SPECIAL FEATURE- Outsourcing Formulation Development & Manufacturing: CDMOs Are Making Their Supply Chains More Resilient & Secure

Growing R&D activities, personalized medicines, large-scale production of biologics, and access to new technologies are some of the biggest reasons why the contract development and manufacturing organization (CDMO) market is expected to practically double from $168 billion this year to $318 billion by 2034.1

“Contract development services are in high demand as pharmaceutical companies face challenges in bringing products from development to market quickly and efficiently,” says David Crawford, Associate Director – Manufacturing, Almac Pharma Services. “Companies are increasingly seeking development-driven CDMOs that offer fully integrated services, ensuring a seamless transition from pharmaceutical development to industrial-scale manufacturing. This approach accelerates time-to-market, mitigates risks, and optimizes resources.”

Mitigating risk and optimizing resources are also presenting challenges for CDMOs, particularly in the current geopolitical environment: the uncertainty of potential tariffs placed on incoming materials; waiting to see if The Pills Act passes; and the passage of The BioSecure Act – the latter two borne out of the pandemic. The PILLS Act (aka Producing Incentives for Long-term Production of Lifesaving Supply of Medicines) was introduced in February by Representative Claudia Tenney (NY-24) to promote the domestic production of generic medicines through tax incentives and reducing reliance on India and China for these drugs. Similarly, The BioSecure Act prohibits executive agencies (i.e., FDA, CDC, and NIH) from contracting or extending loans or grants to any company with current or future commercial arrangements with a “biotechnology company of concern,” such as those located in China.

As a CDMO founded in response to global supply challenges during the COVID-19 pandemic, Resilience has a deep interest in the evolving landscape of trade policies and tariff regulations. “We recognize the uncertainty these changes can create for our partners,” says Cyril Kelly, Senior Manager, Procurement-Distribution, Logistics, Warehouse and Transportation. “We’ve begun taking steps to help mitigate concerns. Through continuous, ongoing monitoring, our supply chain team is closely tracking tariff developments and assessing the impact on suppliers and products based on country of origin while also considering how to minimize disruptions to overall supply chain. We’re leveraging supply chain engineering to reduce risk exposure and deliver targeted support that helps our partners interpret Harmonized Tariff Schedule classifications, assess general tariff exposure, and maintain compliance with international trade laws. We can facilitate conversations with trusted partners who specialize in cross-border transaction assessments to help further navigate these changes with confidence and help alleviate risk.”

In fact, many life science leaders view the current geopolitical conditions as an opportunity. “Contract manufacturing appears to be more in demand, perhaps due to the global geopolitical conditions creating uncertainty in the marketplace,” says Janice Cacace, Executive Director Pharmaceutical Development, Bend Bioscience. “With the push toward US manufacturing, and uncertainty in the feasibility of some offshore supply, plus tariff negotiations, we have seen an increase in requests for tech transfer projects for clinical and commercial manufacturing to customers who are looking to de-risk their overseas supply chain. We can no longer rely on the ‘just- in-time’ operations of previous years, and the tariff situation has become a key risk factor. So, we are shoring up the supply chain and sourcing alternate suppliers as risk dictates. We are derisking by sourcing materials earlier in the development phase through to commercial manufacturing to ensure robust and continuous supply. This has resulted in the discovery that several basic OSD ingredients have different behaviors in formulations, despite being similar in description. Upfront understanding of these differences will save time and decrease risk in any future development program.”

In addition to sourcing earlier, CDMOs are strengthening their supply chains in other ways as well. “To navigate these geopolitical uncertainties, we are enhancing our supply chain resilience by diversifying our supplier base and investing in domestic manufacturing capabilities,” says Dr. Richard Johnson, Chief Scientific Officer & Founder at Upperton Pharma Solutions. “These measures aim to mitigate risks, ensuring uninterrupted service to our clients.”

Likewise, Aragen has proactively implemented a dual-sourcing strategy to improve supply chain resilience for critical active/inactive materials, functional and specialized excipients, consumables and packaging components, particularly those sourced from geopolitically sensitive regions. “We are also expanding our qualified vendor base across multiple geographies, to ensure business continuity and regulatory compliance,” says Vaibhav Sihorkar, Vice President & Head – Formulations Solutions, Aragen Life Sciences Ltd. “These efforts are closely aligned with our supply chain digitization and quality risk management practices, allowing us to maintain reliable clinical and development supply timelines for our global clients.”

While pharmaceuticals were initially exempt, the possibility of significant tariffs on pharmaceutical imports could have profound implications for the global pharmaceutical industry and CDMOs with operations largely outside the US. By concentrating on cost management, cultivating strategic partnerships, prioritizing robust compliance, proactively managing risk, and embracing holistic supply chain transformation, CDMOs are proactively turning tariff-related complexities into competitive advantages.

At Abzena, for example, the company is reshaping its supply chain strategy to thrive in a complex global market. “In the current geopolitical landscape, and among recent discussions about tariffs on pharmaceutical products and the BioSecure Act, our fully integrated, US-based manufacturing model offers a strategic advantage, often delivering a 25% price edge over many international competitors,” says Dr. Campbell Bunce, Chief Scientific Officer of Abzena. “By leveraging domestic partners for sterile filling, lyophilization, and packaging, we effectively manage the entire supply chain from monoclonal antibody (mAb) production to final drug product within the United States. This approach helps us minimize the unknown risks posed by global trade shifts for our customers.”

More insight from these and other life science leaders follows in this exclusive Drug Development & Delivery annual report.

Abzena: Fully Integrated Approach Takes Best Molecules to Development

Abzena’s flexible and customizable approach across a broad range of formu­lation and manufacturing services for bio­logics and bioconjugates enables the CDMO to support a product throughout its entire lifecycle – from initial pre-formula­tion studies and generation of a formula­tion to support toxicology, first-in-human (FIH) clinical trials through to clinical in-use studies, formulation optimization, robust­ness, device interaction studies all the way through commercial scale manufacturing. This enables customers to utilize a single organization for all their formulation, an­alytical and manufacturing requirements, which streamlines and de-risks the process and allows any experience and learnings to be shared across teams. This first-hand knowledge of the product can then be ap­plied to rapidly solve any complex prob­lems that may arise downstream.

“By offering a fully integrated, ‘discov­ery through manufacturing’ approach, and extensive expertise across antibody engineering, analytics, bioassay, biocon­jugation, cell line development and scale up, we are able to design, optimize and select the best molecules to take into de­velopment, increasing their likelihood of clinical success,” says Dr. Campbell Bunce, Chief Scientific Officer of Abzena.

With regard to client success, a cus­tomer came to Abzena with a monoclonal antibody (mAb) formulation that had per­formed well in Phase I clinical trials, but the client wanted to transition from intra­venous (IV) to subcutaneous (SC) adminis­tration for subsequent clinical studies and commercialization. The target concentra­tion was 150mg/mL, which, while being stable, significantly exceeded the viscosity limit for SC injection devices (20cP). At this concentration, the formulation exhibited a viscosity of 34cP, making it unsuitable for use with standard SC delivery devices, he explains.

To address this, Abzena’s formulation team undertook a screening process to identify viscosity-reducing excipients. Sev­eral buffers were tested to determine their impact on viscosity without compromising stability. This process revealed an excipient that reduced viscosity to within the accept­able range for SC injection while main­taining the biologic’s stability. Stress testing confirmed that the selected excipient did not introduce instability.

“In fact, it marginally improved the protein’s resistance to aggregation under accelerated conditions,” says Dr. Bunce. “The reformulated product successfully met all requirements for SC delivery and progressed to clinical studies.”

He does attribute Abzena’s client suc­cesses in part to the company’s leveraging of artificial intelligence (AI) and machine learning (ML) to create a model that can predict formulation stability over long-term storage using early-stage data. “This model is particularly beneficial in projects with tight timelines driven by customer needs,” he says. “Through the generation of high volumes of qualitative data across multiple analytical parameters, we are expanding the potential of AI and ML towards optimizing manufacturing processes, which can dramatically reduce development timelines and costs in ways that were previously unimaginable. By un­derstanding and integrating such ad­vanced tools, there is potential to analyze complex biological systems more precisely, leading to faster and more effective out­comes. At Abzena, we actively seek out and incorporate these new technologies into our processes so that we can offer our customers more efficient development pathways, ultimately helping to bring their products to patients more quickly and at a lower cost.”

Adare Pharma Solutions: 3D Screen Printing for Personalized & Precision Therapies

Adare Pharma Solutions offers fully integrated CDMO services, from early-stage development through to commercial manufacturing and packaging. The com­pany specializes in innovative oral solid dosage forms – including multiparticu­lates, orally disintegrating tablets, sprinkle formulations, and other patient-centric technologies – that help sponsors over­come hurdles in adherence and therapeu­tic performance.

“We’re large enough to offer a full range of global capabilities, yet agile enough to give every project the attention it deserves,” says Steven Facer, Senior Vice President of Sales and Marketing, Adare Pharma Solutions. “We integrate seamlessly with our customers’ teams and values, bringing a customer-first mindset to every engagement. We don’t see ourselves as service providers, we see ourselves as long-term partners invested in shared success.”

He says that Adare is seeing growing interest is in fully integrated partnerships that span the entire lifespan of a project’s journey. As sponsors face increased pres­sure to manage timelines, reduce risk, and bring complex therapies to market effi­ciently, they want to work with strategic CDMO partners that can deliver end-to-end support and maintain continuity throughout the program lifecycle.

Adare Pharma Solutions has em­braced technology in drug development. A notable example is its partnership with Laxxon Medical to provide customers with advanced 3D screen printing capabilities. “This additive manufacturing technology allows for the precise, layer-by-layer con­struction of drug formulations with inte­grated immediate, extended, delayed, and sequential release, all in a single tablet,” says Mr. Facer. “It also allows for the incor­poration of multiple APIs with distinct phar­macokinetics. Unlike traditional laser or nozzle-based methods, the 3D screen printing process is scalable from lab to commercial production. This offers spon­sors a transformative solution for personal­ized and precision therapies, helping them achieve smarter, more targeted drug deliv­ery without compromising cost or volume.”

Adare is also taking proactive steps to structure its operations to help customers navigate global challenges, including the impact of tariffs. Mr. Facer says the CDMO maintains a strong network of develop­ment and manufacturing facilities in both the US and Europe to provide flexibility and access while minimizing disruption from tariffs or other trade-related pressures.

“We’ve also invested in diversified sourcing strategies and flexible operations, and we’re actively supporting customers who are reshoring manufacturing to the US or strengthening their presence in Eu­rope,” he adds. “Our goal is to help spon­sors safeguard supply chains, ensure continuity, and deliver results in an unpre­dictable landscape.”

Almac Pharma Services: Tailor-Made Solutions for Complex Formulations

Almac’s formulation development and manufacturing services offer comprehen­sive support from early-stage clinical de­velopment to commercial manufacturing and packaging. Services include formula­tion development, specializing in develop­ing solid and liquid oral dose formulations, ensuring that drug products meet patient needs. Process Development and Scale-Up provides pre-formulation studies, process development, scale-up, validation, product launch, and ongoing commercial supply. Manufacturing Operations address various dosage forms, including tablets, capsules, stick packs, and sachets.

“What makes us unique is our com­mitment to quality, our ability to solve com­plex challenges through a wide range of expertise and experience, and our ability to offer tailor-made solutions for every sin­gle client,” says David Crawford, Associate Director – Manufacturing, Almac Pharma Services. “By leveraging our single-source platform, clients benefit from reduced timelines and simplified project manage­ment, making us a reliable partner in the industry.”

Mr. Crawford says that both contract manufacturing and contract development services are in high demand, particularly due to the increasing complexity and vari­ety of drug modalities that require special­ized manufacturing capabilities. There is also demand for the development and manufacture of high potent and pediatric medications as well as for personalized medicines.

Almac Pharma Services successfully resolved the development issue for a client who faced challenges with its formulation and GMP manufacturing process. The client wished to develop a low dose, uni­form formulation across multiple dosage strengths. The formulation needed to re­main stable across the product lifecycle. Almac Pharma Services recommended a detailed development plan, including:

• Powder characterization of both non-GMP and GMP batches;
• Development of lab-scale prototypes with extensive tablet testing (weight, hardness, friability, disintegration, disso­lution, and content uniformity);
• Accelerated stability programs to ‘stress test’ formulations;
• Statistical design of experiments to ex­plore critical process parameters and critical material attributes;
• Engineering batches using GMP equip­ment to confirm the manufacturing process;
• Comprehensive in-process testing and stability packaging;
• GMP Clinical and Registration batches with associated stability studies;
• Scale up, prototype batches;
• Process Performance Qualification (PPQ) batches, with enhanced sampling and testing regimes to gain better prod­uct understanding; and
• A robust Continuous Process Verification (CPV) program to monitor product vari­ables and shifts to aid product knowl­edge and to enable proactive interventions, if required.

“As a result, we developed a robust manufacturing process and formulation leading to a successful clinical study and product approval,” says Mr. Crawford.

Aragen Life Sciences Ltd.: Accelerating the CMC Path with Clinical DP & DS Delivery

Aragen operates as a fully integrated CRDMO, offering end-to-end solutions that take new chemical entities (NCEs) from discovery, through clinical candidate nomination, to CMC, through the phase-appropriate drug substance/drug product development and manufacturing. The company aligns drug substance (DS) and drug product (DP) development under one roof, ensuring that formulation strategies are both scientifically grounded and oper­ationally seamless across the molecule’s lifecycle, says Vaibhav Sihorkar, Vice Pres­ident & Head – Formulations Solutions, Aragen Life Sciences Ltd.

“Within this ecosystem, formulation sciences play a pivotal role, serving as the bridge between exploratory research and clinical execution, and eventually translat­ing discovery into clinic through integrated formulation excellence,” he says. “Our formulation CRDMO capabilities begin with pre-formulation support during the discov­ery phase, offering salt and polymorph screening, solid-state and particle engi­neering, bio-relevant solubility profiling, excipient compatibility, and pharmaceuti­cal developability assessments. These are tailored to determine whether a molecule is CMC-enabling or CMC-challenging.”

Mr. Sihorkar says that this is a critical distinction that shapes the path to the clinic. Formulations designed for preclini­cal studies must not only achieve target ex­posures in rodent and non-rodent models, but also withstand the rigor of scale-up, stability, and manufacturability.

“Our deep technical strength lies in solving formulation challenges for a wide spectrum of difficult-to-develop molecules, including poorly soluble ‘brick dust’ com­pounds, chemically or physically unstable actives, and high-dose drugs with poor flow or compressibility profiles,” he says. Technologies such as spray drying, hot-melt extrusion, nanosizing, lipid-based systems, multi-particulates, and long-act­ing injectables are applied based on a compound’s bio/pharmaceutical needs and physicochemical properties. For in­stance, in amorphous solid dispersion de­velopment, Aragen assesses drug-polymer miscibility using advanced thermal analy­sis, computational prediction of interaction energies, and solid-state NMR, ensuring molecular-level dispersion and long-term physical stability. Design of Experiments (DoE) is applied to optimize process pa­rameters and control particle size, mor­phology, and residual solvents – each influencing downstream scalability and bioavailability.

Mr. Sihorkar says Aragen clients are increasingly seeking early, scientifically in­formed formulation strategies to support IND-enabling studies and de-risk clinical entry. The CRDMO supports this with sci­entifically sound clinical DP strategy de­ployment, developing validated analytical methods, clinical batch manufacturing, and packaging for FIH through Phase 2 trials. “Our solutions range from drug-in-capsule (DiC) and drug-in-bottle (DiB) ap­proaches to simple (tablets, capsules) and complex (micronization- and SDD technol­ogy-based) oral solid dosage forms, in­jectables, and modified-release systems,” he explains. “This integrated approach al­lows us to go beyond formulation support and truly accelerate the CMC path with clinical DP and DS delivery.”

A recent case illustrates Aragen’s problem-solving capability. An NCE with low aqueous solubility failed to meet sys­temic exposure targets even after prior micro-sizing, nanosizing and SDD at­tempts by other vendors. The Aragen team reassessed the molecule’s developability through comprehensive physicochemical and solid-state profiling, based on princi­ples of molecular pharmaceutics. “We de­signed tailored polymer selection that provide Tg and/or viscoelastic advantages to optimize and maintain both solubility advantage and extended stability from crystallisation, reformulated it using a re­fined spray drying strategy,” he explains.

The reformulated compound achieved over 3-fold improvement in pre­clinical exposure, allowing the client to progress through regulatory toxicology and initiate clinical material manufactur­ing at Aragen’s site, all executed under one integrated program. “We also inte­grated newer and upcoming technologies like Atomic Layer Deposition (ALD), nano-structured lipids and second-generation LAI technologies that offer precise and im­proved solubility, stability, and release con­trol,” he says.

Ardena: Translating Complexity Into Clinical Reality

Ardena is a fully integrated CDMO and Bioanalytical CRO with a core focus on precision medicine and the develop­ment of innovative, complex therapeutics. Formulation development and manufac­turing services span small-molecule APIs, high-potency APIs (HPAPIs), controlled substances, and advanced drug products, including nanomedicines. Seamless inte­gration of services across the development lifecycle allows Ardena to mitigate risks, ensure smooth project execution, and ac­celerate time-to-clinic. A dossier-centric approach ensures regulatory considera­tions are embedded from the outset, align­ing scientific development with compliance expectations.

“Today’s innovators are seeking flex­ible, science-led partners who can support fast-moving programs with the right ex­pertise at the right time,” says Ariane De Ganck, Chief Commercial Officer at Ar­dena. “Our integrated model was de­signed with exactly that in mind: helping our customers translate complexity into clinical reality.”

In recent years, the company has ob­served a growing need for agile and phase-appropriate development. “Early-phase programs often require rapid itera­tion and adaptability, which our integrated platform is well-equipped to provide,” she says.

A testament to Ardena’s problem-solving capabilities is its collaboration with Race Oncology in manufacturing the first cGMP batch of bisantrene formulation, RC220. Faced with the challenge of meet­ing stringent quality standards for intra­venous human clinical trials, Ardena provided comprehensive support, ensuring compliance with regulatory requirements from the EMA, FDA, and TGA. “Our integrated approach facilitated the successful production of the drug product, demon­strating our commitment to excellence in pharmaceutical development,” says Ms. De Ganck.

Technological advancements play a pivotal role in enhancing Ardena’s formu­lation development and manufacturing processes. The CDMO is actively incorpo­rating digitization, machine learning, and process automation to support data-driven decision making and enable more agile and dynamic workflows. “Alongside our $23 million investment in a state-of-the-art nanomedicine facility in Oss, the Netherlands, which features GMP-compli­ant cleanrooms, advanced process devel­opment laboratories and integrated ana­lytical capabilities, we are also expanding our bioanalytical services footprint in both Europe and the US,” explains Ms. De Ganck. “In bioanalysis, we are deploying machine learning tools to streamline data interpretation and enhance the robustness of complex assay workflows.”

In addition to expanding investments in facilities and equipment, Ardena is ex­panding its ability to address potential im­pacts from tariffs and regulatory changes such as the BioSecure Act. “We are proac­tively strengthening our supply chain re­silience.,” she explains. “Our strategic expansion into North America, marked by the acquisition of Catalent’s Somerset, New Jersey facility, enhances our ability to manage material supply and regulatory compliance across regions. This facility, a Center of Excellence for advanced oral dosage forms, complements our European operations and reinforces our global man­ufacturing capabilities.”

Ascendia: Map Out Challenges Early to Optimize Formulations

Ascendia offers enabling formulation platforms for addressing the challenges associated with poorly soluble or bioavail­able drugs across all modalities. As more and more new molecules being discovered are poorly soluble and less bioavailable, Ascendia’s core technologies can help ex­pedite the development by reducing time and saving cost.

“Our seamless approach offers a unique value proposition for all clients working with high melting and/or higher logP molecules,” says Shaukat Ali, PhD, Senior Director, Scientific Affairs & Techni­cal Marketing, Ascendia. “For example, in cases where the molecules behave like brick dust or hydrophobic, AmorSol® re­quiring the appropriate polymers and sol­ubilizers can be used to further expedite from proof of concept to optimized formu­lations with the desired solubility and bioavailability. In other cases, if the mole­cules are lipophilic, EmulSol® or NanoSol® might be better options for bringing those molecules to clinic.”

Ascendia’s four enabling solubiliza­tion technologies offer a 180-degrees ho­listic approach to resolve the challenges with NCEs. “Tailored formulations for an API coupled with timely delivery are key at­tractions to our clients,” he says. “Building trust starting with “promises made and promises kept” to meet the deadlines for developing formulations with FDA ap­proved excipients, invaluably expedite the in vivo testing for pharmacokinetics (PK) data in animals, which are essentials for IND filing to initiate the human clinical tri­als. Thus, it is essential to map out the ear­lier challenges to understand the efficacy of an API in the formulations and to opti­mize the right ones for scale up for addi­tional pre-clinical data in higher animals like dogs and monkeys among others, and to start the clinical studies.”

Ascendia’s contract manufacturing ca­pability handles controlled substances (Category 3-5) and highly potent mole­cules (OEL 1-4). In addition, clean rooms are specifically designed to handle aseptic with fill-finish coupled with lyophilization capabilities with 50L manufacturing batches for clients working with small and large molecules and biologics. Further­more, Ascendia’s capabilities utilize a Delta Vita Gamma Vita for nanosuspen­sions wet milling in ISO 5 clean rooms, of­fering additional values for clients interested in scaling up larger batches ranging from 600mL to 25L and 100L for clinical trials and commercial manufactur­ing. LipidSol®-enabling technology is unique for small and large molecules en­capsulated in lipid nanoparticles and poly­meric nanoparticles for modified and extended release, and long-acting in­jectable drugs. Dr. Ali says: “Coupled with our new microbial lab and latest water for injection (WFI) plant with 1000’s of liters of capacity offers a unique value proposition for our clients for seamless transition from early phase to later phase clinical develop­ment.”

Leveraging its technical expertise and manufacturing practices for injectable and oral drug products under cGMP, Ascendia continues to play an important role in de­veloping drugs for clinical trials and com­mercial manufacturing. Located in the northeast region of the US, Dr. Ali says that Ascendia is well positioned to handle proj­ects – both aseptic and non-aseptic – de­spite new regulations, tariffs, and the BioSecure Act. “Drug manufacturers with intent to expedite challenging molecules are looking for CDMOs to streamline time and save cost without compromising clin­ical trials and drug products,” he says.

Bend Bioscience: In-Vitro Permeability Ranks Formulations

Bend Bioscience was formed in 2024 through the merging of Bend Bioscience, Oregon, with CoreRx, Florida, and Socie­tal CDMO, Georgia, to broaden the new company’s capabilities to include early de­velopment, spray drying, and solubility en­hancement, and expanded solid dose commercial-scale manufacturing. The new company offers clinical-scale development for spray drying, particle engineering so­lutions, suspensions and microsuspen­sions, solid dose development, and clinical and commercial manufacturing of cap­sules, tablets, mini-tablets, granulates, and particulates. These services are built across vertical integration of design – formulation and process determination based on the Target Product Profile (TPP); develop – process scale-up and analytical; and man­ufacture – at clinical and commercial scales.

“As a CDMO, we encounter develop­ment issues on a regular basis,” says Janice Cacace, Executive Director Pharma­ceutical Development, Bend Bioscience. “Whether from solubility or physical prop­erties, new molecules don’t often behave as expected during formulation and/or scale-up.”

For example, a client was not achiev­ing the bioavailability results they wanted for a suppository dosage form. One of the tools Bend uses for formulation selection is in-vitro permeability through a bio­mimetic membrane, which was used to evaluate the in-vitro permeability of the API out of different suppository formulation bases, alone, and with permeability enhancers.

“We were able to discern that concen­tration and particle size were not contribut­ing factors, but that the root cause was the API had a preference to stay in the original lipophilic suppository base and not diffuse, making it unavailable,” she explains. “The in-vitro permeability results enabled us to rank formulations from different bases and enhancers, leading ultimately to a lead product that displayed improved bioavailability.”

Bend Bioscience is developing tools that enable the ability to ‘learn’ from the breadth of drug delivery, and in particular structure-formulation patterns with respect to TPPs and then apply that knowledge to active development programs to save time and decrease risk. For instance, in devel­opment, AI is helping to understand and predict scale-up parameters in the spray drying process. “Our goal is to incorporate AI tools in process design and, ultimately, for it to be the ‘holy grail’ in automating and managing our processes throughout commercial manufacturing operations,” she says.

BioDuro: Delivering In-Vitro/In-Vivo Results In Just 4 Weeks

BioDuro delivers integrated preformu­lation, formulation development, and manufacturing services. Its formulation team is co-located with the API and DMPK teams, enabling accelerated IND-enabling services through seamless cross-functional collaboration.

“Our preformulation services are grounded in rigorous scientific analysis,” says Dr. Hong Li, Vice President of Formu­lation at BioDuro. “We conduct compre­hensive physicochemical profiling – assessing pKa, logP, stability, and hygro­scopicity assessments – to support optimal candidate selection and proactively ad­dress potential delivery challenges.”

For example, strategic salt and poly­morph screening is employed to enhance crystal form stability and drug perform­ance and advanced bioavailability en­hancement techniques – including amorphous dispersions, co-crystals, and lipid-based formulations, which enable ef­fective delivery of poorly soluble com­pounds.

BioDuro’s formulation capabilities support a broad range of dosage forms, including oral solids, injectables, topicals, and ophthalmics. A proprietary Solution Engine solubility platform is designed for speed and flexibility, with more than 100 successful IND filings. Dr. Li says: “We rou­tinely deliver IND-ready formulations in 8-12 weeks, including animal PK studies. Utilizing cutting-edge enabling technolo­gies such as spray-dried dispersions and hot-melt extrusion, we provide phase-ap­propriate formulations tailored to each stage of development, from preclinical through to commercial production.”

In fact, Dr. Li says there is increasing demand for integrated IND programs that can reduce both development timelines and overall costs. She says this can be at­tributed to a rising number of projects stemming from orphan drug designations and fast-track programs where CMC time­lines are becoming more compressed.

BioDuro also has seen growing de­mand for development services, driven largely by the increasing complexity of drug molecules and the emergence of new therapeutic modalities such as GLP-1s, peptides, and antibody-drug conjugates (ADCs). Dr. Li explains that these innova­tions require advanced formulation strate­gies and highly customized development approaches, capabilities that many phar­maceutical companies may lack in-house.

In addition, the growing prevalence of poorly soluble compounds has led to heightened interest in proven bioavailabil­ity enhancement technologies such as spray-dried dispersions and hot-melt ex­trusion. When paired with in vivo PK stud­ies, these services are becoming increasingly popular for their ability to ac­celerate and de-risk development.

As an example, one biotech client ap­proached BioDuro with a highly challeng­ing early-phase API characterized by extremely poor solubility, limited available material, and an accelerated development timeline. “Speed and precision were essen­tial, as the compound needed to advance rapidly toward preclinical evaluation,” says Dr. Li. “Due to the molecule’s poor solubil­ity, we identified amorphous solid disper­sion (ASD) as the optimal strategy to enhance bioavailability. Spray drying was selected as the enabling technology, given its shorter development timeline and min­imal material requirements.”

BioDuro’s team began with compre­hensive in silico modeling, screening more than 20 polymer/API combinations. “This virtual approach enabled rapid excipient selection without consuming any API and was completed within a single day,” she says.

Guided by the modeling results, the team minimized experimental screening by focusing only on the most promising API/excipient pairs. With a strategically de­signed experimental plan, a formulation was developed within two weeks using less than 100mg of API.

Subsequently, the DMPK team con­ducted two rounds of rodent pharmacoki­netic (PK) studies to select the optimal ASD formulation. Compared to in vitro dissolu­tion alone, in vivo PK data provided a more accurate assessment of product per­formance, she says. This stage was com­pleted in less than 10 days.

“The result was a complete data package, including both in vitro and in vivo results, delivered in just four weeks,” says Dr. Li. “The final formulation demon­strated over a 12-fold improvement in bioavailability compared to the unformu­lated (neat) API. With robust PK data in hand, the client was able to initiate drug product manufacturing with us and move confidently toward IND filing.”

Bora: Improved a Drug Product’s Stability Up to 12 Months

Bora offers development and manu­facturing services for a broad range of dosage forms including OSD, semi-solid, liquid, ophthalmic and sterile injectable products. In Maple Grove, MN, Bora houses quality control labs and dedicated R&D to support phase-appropriate prod­uct and analytical development, and seamless scale-up to cGMP clinical and commercial production of oral solids, powders, and liquids.

“Our expansive global network in­cludes facilities across the US, Canada, and Taiwan, with the flexibility, global ca­pacity, and robust infrastructure to support complex development and manufacturing for a broad range of drug products,” says Helen Clark, PhD, Senior Technical Direc­tor, Bora. “With our experience in scale up, and expansive global network of commer­cial-scale capacity, we are seeing demand from clients looking to establish domestic supply centers, and from “friendshoring” (a preference for manufacturing and sourcing from countries considered geopolitical allies) initiatives for regional supply.”

One client recently approached Bora to establish a formulation strategy for an oral solution. The client’s API was not sta­ble at high temperatures and high humid­ity. To fully understand the reasons, Bora conducted API stress studies to confirm the reaction pathway. These included a com­plex forming agent (betadex) to facilitate the solubility of the API and provide better stability of the drug product. The study is ongoing, but at room temperature condi­tions Bora has helped improve the drug product’s stability up to 12 months, ex­plains Dr. Clark.

Within Bora, technologies are trans­forming formulation development by en­hancing precision, speed and data-driven decision-making, which can significantly reduce the time and costs associated with early-stage R&D, she says. In manufactur­ing, for example, the use of automation, such as isolator-based technology for aseptic fill/finish, can help streamline com­plex tasks and reduce human error and contamination risks, enabling faster, safer, and more efficient manufacturing of es­sential therapies.

“With integrated data systems and AI-powered operational efficiency, develop­ment and manufacturing teams can make proactive, predictive, and data-driven de­cisions at every stage, from formulation to fill/finish, ultimately accelerating timelines and bringing high-quality, life-saving products to market faster and at scale,” says Dr. Clark.

Catalent: Formulation Strategies Meet Aggressive Timelines

Catalent provides comprehensive for­mulation development and manufacturing services across all major therapeutic modalities, including small molecules, bi­ologics, and advanced therapies. Services span the entire product lifecycle, from pre­clinical formulation design and analytical method development through clinical manufacturing to commercial production and global distribution. William Wei Lim Chin, PhD, Senior Manager, Scientific Mar­keting, Catalent, says that what distin­guishes Catalent is its integrated, end-to-end approach. Scientific and tech­nical teams collaborate across develop­ment, analytics, delivery, and supply to reduce complexity, accelerate timelines, and support formulation strategies that meet patient and program needs.

He says: “Whether designing modi­fied-release oral forms for chronic condi­tions, scalable fill-finish processes for biologics, or supply logistics for cell and gene therapies, Catalent adapts technolo­gies and workflows to fit clinical and com­mercial goals.”

Digital tools, automation, and artifi­cial intelligence are being implemented across Catalent’s network to improve client responsiveness, process control, and data integration. In aseptic processing, Catalent has implemented real-time viable particle monitoring systems that detect contamination risks early and allow quicker resolution through automated tracking and traceability. Embedded process analytical tools like Raman spec­troscopy provide real-time process visibility and support upstream quality assurance.

Modern laboratory information sys­tems enable automated calculations and continuous trend analysis. “This gives quality teams reliable insights faster and supports proactive decision-making,” says Dr. Chin. “In cell therapy, Catalent has au­tomated high-throughput assays for flow cytometry, cytotoxicity, and cytokine re­lease, replacing manual testing and im­proving consistency.”

Catalent has observed greater de­mand for contract development, especially from emerging biopharma companies. Dr. Chin says these organizations often seek partners who can provide both scientific insight and operational execution early in development to reduce risk and move pro­grams forward faster. This demand is driv­ing increased interest in integrated programs that combine formulation de­sign, process development, and GMP manufacturing. Catalent supports this need with flexible, phase-appropriate serv­ices that enable rapid iteration, reliable tech transfer, and efficient transitions from early-stage work to later-phase manufac­turing, he says.

Catalent recently supported a sponsor with a poorly soluble API and limited sup­ply that needed to complete Phase 1 trials under aggressive timelines. Traditional fixed-dose manufacturing would have re­quired excessive capsule counts and lengthy stability testing, which would have delayed the study and consumed valuable API, Dr. Chin explains.

“We implemented an on-demand manufacturing approach using a lipid-based formulation and extemporaneous softgel capsule filling at the clinical site,” he says. “Two fill concentrations were de­veloped to cover a 75-fold dose range. Rather than producing multiple finished strengths, intermediate fill material was manufactured under GMP conditions and shipped to the clinical site.”

Clinical pharmacists at the contract research organization were trained by Catalent to fill and seal softgel capsules using manual techniques. Training in­cluded proper handling of nitrogen-filled lipid formulations, capsule sealing meth­ods, fill accuracy, adherence to in-use sta­bility timelines, and batch record documentation. “This ensured consistency, dosing precision, and regulatory compli­ance during trial execution,” he says.

Intermediate stability data and well-characterized materials supported regula­tory approval of this approach. The program reduced API usage by more than 50%, minimized unnecessary batch pro­duction, and enabled the successful com­pletion of the trial within the required 30-week timeline.

CuriRx, Inc.: Integrated Approach Combines Advanced Science With Early-Stage Manufacturing

CuriRx, Inc. is a woman-owned small business and full-service CRDMO special­izing in injectable formulation develop­ment, analytical testing (GMP and non-GMP), and pre-clinical batch manu­facturing for clients worldwide. Its expertise spans a range of molecule types, including complex biologics. CuriRx offers end-to-end services from pre-formulation through dosage form development, including ad­vanced delivery systems such as lyophilized products, nanoparticles, lipid nanoparticles (LNPs) for mRNA, lipo­somes, micelles, and complexation-based formulations. The company supports non-GMP manufacturing for early-stage stabil­ity and animal studies, including prefilled syringe (PFS) fills.

“Our integrated approach – combin­ing advanced formulation science with early-stage manufacturing – helps clients de-risk development and accelerate time­lines,” says Indu Javeri, PhD, President & CEO of CuriRx.

Currently, CuriRx’s contract develop­ment services are in high demand, partic­ularly among early-stage biotech companies seeking solutions for complex delivery challenges and scalable processes. “Our reputation for solving for­mulation issues – especially for biologics and advanced delivery systems – has made us a preferred partner for preclinical and IND-enabling programs,” she says.

Analytical capabilities include chro­matography, spectroscopy, USP/EP meth­ods, and high-resolution LC-MS. CuriRx operates under GLP and cGMP standards and is ISO 9001 certified. Its scientists have contributed to the development of commercial products like Humira, Synagis, Blincyto, and Gattex. CuriRx also formu­lated a personalized peptide vaccine for terminal melanoma patients, whose results were published in Nature.

In collaboration with IAVI and Rocke­feller University (funded by the Gates Foundation), CuriRx developed high- concentration antibody formulations (150mg/mL) for subcutaneous injection, achieving acceptable viscosity and injectability.

“We also helped a client overcome adsorption issues in a bispecific antibody formulation, developing a stable lyophilized product with over two years of shelf life allowing for patent application by the client,” says Dr. Javeri. “In addition, our analytical methods enabled accurate quantification, supporting successful Phase 2 trials.”

Fortis Life Sciences: Streamlining Nanomedicine Development

nanoComposix, now part of Fortis Life Sciences, provides comprehensive formulation development and manufacturing services focused on inorganic and polymeric nanoparticles for therapeutic and diagnostic applications. With core competencies in mesoporous silica, colloidal gold, and PLGA-based systems,  the company supports pharmaceutical programs from feasibility assessment through cGMP manufacturing. “All materials are produced in the US, which minimizes supply chain disruptions, streamlines logistics, and ensures full oversight of production quality—factors of increasing importance in a globally constrained manufacturing environment,” says Stephanie Morris, Nanomaterials Product Manager, Fortis Life Sciences.

A feature of nanoComposix’s approach is translating custom nanoparticle formulations from early research into clinical-grade materials without changing suppliers or platforms. This is achieved through in-house process development, extensive analytical capabilities, and a cGMP QMS geared towards 21CFR Parts 210 and 211 that supports customers with compliance to applicable regulatory requirements. Ms. Morris says: “Clients benefit from tailored nanoparticle design—optimized for parameters such as size, surface chemistry, payload compatibility, and release kinetics—along with reproducible scale-up and batch-to-batch consistency.”

In one recent case, a pharmaceutical company sought to develop a mesoporous silica nanoparticle (MSN) as a delivery vehicle for a cancer immunotherapy. The project began with feasibility testing to evaluate multiple MSN variants and determine which structural properties best supported the therapeutic mechanism of action. nanoComposix tailored the nanoparticle properties to the unique requirements of the immunotherapy, then developed and validated a manufacturing process that scaled production by a factor of 1000. “We produced the material under cGMP conditions for preclinical studies, allowing our client to proceed with confidence into the next development phase,” she explains.

In another engagement, nanoComposix worked with a client developing a PLGA-based nanoparticle immunotherapy. The program began with the integration of the active pharmaceutical ingredient into a biodegradable polymer matrix designed to meet specific delivery and stability criteria. The project progressed through process development, scale-up, and technology transfer, culminating in the production of GMP-compliant material for Phase I and Phase II clinical trials. By managing both formulation and manufacturing under one roof, the program avoided common delays associated with external handoffs or platform changes, says Ms. Morris.

nanoComposix’s focus on formulation flexibility and U.S.-based production has positioned the company to support a range of nanomedicine development strategies. Ms. Morris says: “With growing demand for reproducible and scalable nanoparticle formulations, integrated service models like nanoComposix are playing an increasingly critical role in accelerating clinical development and reducing manufacturing risk.”

Gattefossé: Optimizing Pre-Clinical Lipid-Based Formulations

As drug discovery efforts accelerate, formulators are under increased pressure to advance large pipelines of challenging molecules – often ones with solubility and permeability limitations. Lipid-based for­mulations offer key benefits across several routes of administration. These benefits in­clude improved solubility and enhanced in vivo absorption via the oral route as well as penetration enhancement and effective, patient-friendly formats for topical/trans­dermal products. Gattefossé has estab­lished four Technical Centers of Excellence (TCE Labs) in France, the US, India, and China. These labs aid in the selection and optimization of pre-clinical lipid-based for­mulations; provide tailored, hands-on cus­tomer support; and advance lipid knowledge through education and train­ing, explains Nick DiFranco, Senior Mar­keting Manager – Pharmaceuticals, Gattefossé USA.

“We have taken on a wide range of projects in recent years, including lipid screening for poorly soluble drugs, trou­bleshooting of existing formulations, and optimization of late-stage projects prior to clinical and commercial scale-up,” he says. “While many projects involve early-stage screening and optimization, we also work with customers to troubleshoot and opti­mize existing lipid-based formulations.”

Technical capabilities range from screening/compatibility studies for liquid and semi-solid excipients to the develop­ment of binary and ternary systems that utilize multiple lipids to optimize drug loading, maximize drug exposure, and im­prove product performance. Mr. DiFranco says that Gattefossé also performs in vitro lipolysis and Franz cell diffusion testing to simulate in vivo conditions and guide both oral and topical formulation selection.

“Our TCE labs serve the unique pur­pose of streamlining early-stage pre-clini­cal development to ensure a seamless transition to clinical and commercial for­mulations,” he says. “Gattefossé’s TCE sci­entists act as an extension of our customers’ R&D teams, providing hands-on support to overcome difficulties associ­ated with challenging APIs.”

Recently, a customer approached Gattefossé with a clinical-stage lipid-based formulation that was facing inconsistent dissolution and capsule compatibility is­sues on stability. “After fully investigating the client’s formulation and with our deep knowledge of lipid chemistry, we identified that oxidation was the main cause of these formulation challenges,” explains Mr. DiFranco. “Gattefossé TCE Lab worked to identify the best antioxidants along with recommended levels to address the formu­lation issues and allow the client to suc­cessfully complete their clinical trials.”

In addition to oral offerings, Gatte­fossé specializes in creating topical and transdermal solutions. Mr. DiFranco says clients benefit from hands-on develop­ment support and access to prototype for­mulations for creams, lotions, gels, and ointments. “We enable clients to create ef­fective, patient-friendly products, improv­ing API solubility and skin penetration while optimizing key sensory attributes such as texture, rub-in, absorption, and after-feel.”

LATITUDE Pharmaceuticals Inc.: Formulating Challenging Compounds

LATITUDE Pharmaceuticals Inc. spe­cializes in innovative drug formulation de­velopment and GMP manufacturing services. LATITUDE offers tailored formula­tion development for a variety of drug for­mats, including injectable, oral, topical, ophthalmic, and inhalation products. LAT­ITUDE is particularly adept at producing complex liquid formulations like nanoemul­sions, liposomes, and nanoparticles.

“LATITUTDE distinguishes itself through a small-company approach that includes in-depth expertise, direct connec­tion with our project scientists, flexibility, and rapid provision of quality deliver­ables,” says Matthew A. Singer, PhD, Vice President, Head of Business Development, LATITUDE.

The company has successfully formu­lated challenging compounds, addressing issues like poor solubility, instability, and bioavailability. When appropriate, LATI­TUDE can employ proprietary technolo­gies such as ClearSol™, a solubilization platform for difficult APIs, and PG Depot™, a phospholipid gel depot for sustained in­jectable drug release. LATITUDE also pro­vides GLP and GMP-compliant analytical testing services, supporting clients from preclinical studies through Phase 1 and Phase 2 clinical trials.

Since its founding in 2003, LATITUDE has completed more than 1,400 formula­tion development projects for more than 300 clients, “building a reputation for cre­ative problem-solving, reliability, and rapid turnaround,” says Dr. Singer. “For the many clients that come to LATITUDE with solubility (and often bioavailability) is­sues, we offer a well-defined set of ap­proaches that are highly effective to produce a quality drug formulation.”

He says that while both contract man­ufacturing and development are both in demand. “LATITUDE offers both easy tran­sition of our clients’ formulation projects to LATITUDE’s GMP manufacturing, as well as just one or the other service, if that is the need of our clients,” he explains. “And, like most things, demand goes in cycles. For much of the second half of 2024, our con­tract manufacturing was in greater de­mand by established clients, as seed investment in pharma was slow. However, by the end of 2024 and into 2025, LATITUDE is seeing normal demand for both formulation development and GMP manufacturing.”

Lifecore Biomedical: Taking On Tough Projects Others Won’t

Lifecore Biomedical is a US-based in­jectables CDMO providing clinical to com­mercial process development and manufacturing along with end-to-end services like on-site testing and stability as well as packaging, handling, and steriliza­tion options. The company also manufac­tures sodium hyaluronate, which is used in some of the formulations produced for its partners.

“We’re generally recognized as the ‘ones who do the tough stuff’ that others can’t or won’t undertake,” says Ryan Swanson, PhD, Director of Process Devel­opment, Lifecore Biomedical. “We work with many products that are difficult to filter and fill,  especially complex and high-viscosity formulations (>100,000 cen­tipoise). But we also handle products that are not as challenging. Partners in all stages and with products of varying com­plexity choose us because we can handle the unexpected.”

One of these tailored solutions was a biologic formulation that required preci­sion process engineering. During formu­lation, the molecule needs controls for temperature, light, and shear sensitivity. It involves a multi-step chemical reaction within a sterile mixing environment, and a process that is controlled to within 10 sec­onds. Post-mixing, the final formulation has a gel consistency that is difficult to fill. While these individual process steps and controls may not be challenging, the com­bination of all of them created a complex process that involved building a custom formulation skid and multiple program­mable logic controls (PLCs). “We trans­ferred this formulation into Lifecore as a bench scale process, scaled it for clinical GMP batches, and then scaled it again for commercial supply,” he says.

When it comes to supplies, Lifecore’s customers and prospects understand the current macroeconomic environment that is adding uncertainty to supply chains. Dr. Swanson says that technical transfer expe­rience and ability to scale are becoming more valuable as a result. “These compa­nies are considering alternative geogra­phies for manufacturing their products and they appreciate agility in responding with solutions,” he says. “They appreciate Lifecore’s ability to offer flexible options like plant-in-plant concepts or dedicated filling lines that give them a means of gain­ing control over supply chain uncertainty.”

Lonza: Advanced Synthesis Addresses Unmet Medical Needs

In recent years, small molecules and bioconjugates segments have shown a steady increase to an already high level of outsourcing, and current estimates suggest this trend will continue. There is a sus­tained high level of outsourcing originat­ing from Big Pharma players, but the segment growth is driven by small and emerging companies, many of which lack extensive in-house manufacturing capabil­ities. These companies are advancing new products across various modalities, includ­ing small-molecule active pharmaceutical ingredients (APIs) of any potency and bio­conjugates, including antibody-drug con­jugates (ADCs).

Lonza collaborates with its business partners to embrace innovation and man­ufacture drugs by delivering integrated of­ferings that meet the complex needs of global customers. In Advanced Synthesis, Lonza leverages its expertise in classic and complex chemistry and biochemistry to manufacture APIs and ADCs, addressing the unmet medical needs in oncology, au­toimmune diseases, diabetes, and more.

“Our recent collaborations and in­vestments in Advanced Synthesis reflect our commitment to pioneering next-gen APIs and ADCs using cutting-edge science, smart technology, and lean manufacturing for our customers and their patients,” says Christian Seufert, Head of Advanced Syn­thesis, Lonza.

Within the last decade, 70% of new molecular entities approved by the FDA were derived from small-molecule APIs. Global trends, like population growth and aging, are accelerating the need for faster, more efficient drug development. Artificial intelligence (AI), machine learning (ML) and robotics are driving optimization of developing and manufacturing of APIs. Their structural complexity presents a chal­lenge in drug development, particularly synthetic route design. In general, APIs often require complex synthesis that may exceed 20 steps, resulting in extended lead times, increased raw material manage­ment, and heightened supply chain vul­nerability. To tackle this, pharmaceutical developers are increasingly using AI to streamline synthetic route design and pre­dict viable pathways that experienced process chemists can use to optimize syn­thetic routes and reduce complexity, he ex­plains.

Lonza recently launched its AI-En­abled Route Scouting Service, combining the company’s process R&D expertise, proprietary commercial supply chain data­bases, and computer-aided synthesis plan­ning technologies. “With access to global chemical supply chain intelligence bol­stered by the predictive power of AI, the Route Scouting Service streamlines API de­velopment by optimizing synthetic path­ways, enhancing supply chain resilience, and ultimately, enabling faster and more cost-effective drug development,” says Mr. Seufert.

In addition, recent ADC commercial launches have driven the ramp-up of com­mercial volumes and intensified pipeline development. This growth, driven by emerging companies, is increasing de­mand for CDMO support to meet chal­lenging timelines while maintaining high innovation, managing complex supply chains, tight timelines, and overcoming regulatory hurdles.

To solve these challenges, Lonza is making strategic investments and collab­orating with research-based partners. For example, a new bioconjugation suite at Lonza’s Ibex® Biopark will support the manufacturing, handling, and contain­ment of highly-potent modalities. In addi­tion, the integration of AI and predictive tools into its ADC development toolbox (in­cluding Synaffix offerings) will help accel­erate the design and development of next-generation ADC pipelines.

Mikart: Catering to Complex Products

Mikart’s formulation development services encompass pre-formulation stud­ies, drug-excipient compatibility assess­ments, and the application of Quality-by-Design (QbD) principles to en­sure robust and scalable formulations. The company recently expanded capabilities with the addition of a state-of-the-art liq­uids and suspensions suite, enabling the development and manufacturing of com­plex suspension products, including ex­tended-release formulations.

Mikart has made substantial invest­ments to enhance its formulation develop­ment capabilities, particularly in response to client demand for robust and reliable liquid dosage forms. The new liquids and suspensions suite in Atlanta exemplifies this commitment. This facility supports a wide range of volumes, from 50L to 4,000L, catering to the development and manufacturing of complex suspension products, including extended-release for­mulations. These advancements are espe­cially beneficial for pediatric and geriatric product development, areas where Mikart has seen increased demand. Moreover, Mikart’s strategic investments in advanced equipment, such as the Korsch XM12 tablet press and the FlexPack NF-150 Hor­izontal Sachet-Packaging Machine, bolster its development and manufacturing capa­bilities.

Mikart has embraced digital transfor­mation to enhance decision-making in for­mulation development and to create more dynamic manufacturing processes. The company transitioned from paper-based quality processes to a digital platform by implementing TrackWise Digital eQMS. This shift streamlined document approvals and training management, reducing ap­proval times from days to less than a day and improving visibility into training com­pliance. Investments in state-of-the-art equipment, such as the Fette® double-sided tablet presses, have enhanced Mikart’s manufacturing capabilities. These machines offer advanced features like au­tomatic weight control and real-time mon­itoring, enabling precise and efficient production of complex oral solid dose products.

Mikart partnered with Nano Pharma­Solutions to utilize their NanoTrans­former™ technology, a solvent-free, nano-granulation process that enhances the solubility of active pharmaceutical in­gredients (APIs). This collaboration allows for the development and manufacturing of nanomedicines, addressing solubility chal­lenges in drug development.

Gus LaBella, Director of Formulation Development of Mikart, explains that one client recently had a prototype formulation of an amphiphilic drug with very poor water solubility. The formulation used a high concentration of propylene glycol that acted as a co-solvent for the API as well as an anti-microbial agent. However, due to safety and regulatory concerns, it was re­quired to decrease the propylene glycol concentration below a certain level. Vari­ous solubility enhancers and surfactants were screened, and they were not effec­tive, he says. Application of heat was not recommended for the API stability. Eventually, maintaining the original ratio of propylene glycol to water was tried by reducing the overall concentration of propylene glycol by 3 to 5 times in the pro­totype. Because the API is amphiphilic in nature, a specific solvent polarity is re­quired to maintain its solubility with less co-solvent. This co-solvent system exhib­ited monomeric solubilization making it a more robust and stable form of solubility enhancement. Although the reduced propylene glycol was not sufficient to act as an anti-microbial, it effectively solubi­lized the preservatives added to the drug product. The formulation remained simple and efficient, avoiding the need to intro­duce multiple additional excipients.

Nanopharm: Developing Stable Formulations for Oral & Nasal Drug Products

Nanopharm is a specialized contract development organization focusing on orally inhaled and nasal drug product (OINDP) development services, including preformulation and formulation develop­ment, device selection and characteriza­tion, and in silico modelling of regional deposition and systemic bioavailability. The company also offers GMP fill/finish and release/stability studies for early clin­ical development.

“Nanopharm has significant experi­ence working with generic OINDPs and has collaborated with FDA for the past 10 years on developing clinically relevant in vitro and in silico methods to accelerate approval,” says Gemma Budd, General Manager, Nanopharm.

There is a growth in the market for OINDP due to an interest in targeting local delivery to the lungs or nose, as well as re­purposing drugs to offer faster onset or higher bioavailability compared to oral dosage forms, and to overcome patient resistance associated with injections – or even to target direct delivery to the brain. Growth in biologic molecules also makes it more difficult to deliver orally, so nasal and inhalation dosage forms are increas­ingly popular.

“The kinds of projects we work on cover challenges, such as developing a stable formulation with much higher con­centrations of drug compared with oral or injectable dosage forms, as well as opti­mize the device and formulation holisti­cally to enable aerosolization,” she says. “This requires sophisticated formulation strategies, as well as consideration of for­mulation enhancers to increase retention time or accelerate absorption, or particle engineering to preserve drug stability while facilitating delivery and deposition. Fur­thermore, some customers want to target certain regions of the nose or lungs, so we have to optimize the droplet or particle sizes to target these regions and still get high efficiency of dose delivery, which is a very niche area of expertise that not many other CDMOs have.”

 In silico modelling capabilities, such as Simhalation™ and SmartTrack™, allow Nanopharm to factor in disease-specific variables and patient-to-patient variability, which helps to derisk clinical development and refine dosing strategies – a service not available from most CDMOs, she says.

Nano PharmaSolutions: Single Nanoformulation for All Phases With No Solvent or Polymers

Poor solubility remains one of the greatest challenges in pharmaceutical de­velopment. More than 70% of new chem­ical entity (NCE) candidates have poor solubility and therefore poor bioavailabil­ity, which remains one of the main causes of failure for Phase 1 First-in-Human trials. While the number of methods for enhanc­ing drug solubility continues to increase, most of the formulation work is performed after Phase 1 clinical trials due to often-long development time and high quantities of drug required for these solubility en­hancement technology options. However, the regulatory requirements for bridging the safety and human PK studies for intro­ducing enhanced bioavailability formula­tion after the initial Phase 1 study are costly in terms of development time and re­sources. “Solubility-enhancing technology that is suitable at early development stages is more highly desirable now than ever,” says Dr. Kay Olmstead, CEO of Nano PharmaSolutions.

NanoTransformer™ is a scalable drug nanosizing technology that generates nanoparticles of BCS Class II and IV drugs in the 100-300nm medial particle size range. This process uses a physical vapor deposition process used in the aerospace industry to nano-coat these insoluble drugs onto regular excipients using gentle heat and extremely low pressure (<10-6 torr). This N-granulation™ process may be used for animal safety studies as aqueous suspensions as well as for Phase 1 clinical trials without changing the formulation, but instead filling the N-granules into cap­sules, powder-in-capsule, or powder-in-bottle; and as compressed tablets for later-stage clinical trials. Using the same nano-granulation for the base dosage form in all phases of clinical trials removes the need for bridging PK studies required by regulatory agencies for formulation changes during the development phase, Dr. Olmstead explains. “A solvent-free nanoformulation for animal safety studies will ensure the same good exposure of drug is maintained in both animals and humans.”

The NanoTransformer N-granulator is a high-vacuum drug nano-coater, en­abling the production of nanodrugs under cGMP conditions. The development time for nanoformulation is rapid and requires very little API, making this process suitable for preclinical studies as well. Industrial vacuum nano-coaters can generate hun­dreds of kilograms of nanoparticles; there­fore, scale-up to production-sized batches is achievable.

“Solubility and bioavailability en­hancement outperforms solid dispersion techniques like spray drying,” she says.

Nano PharmaSolutions offers GMP manufacturing of clinical supplies of nanomedicines at its co-manufacturing fa­cility at Mikart, LLC (Atlanta, GA). Mikart is a contract development and manufac­turing organization (CDMO) with capabil­ity in developing and manufacturing oral solid and liquid dosage forms. “GMP op­eration of NanoTransformer technology at Mikart with smooth tech transfer from Nano PharmaSolutions and manufactur­ing capability for finished dosage forms for various formats (capsules, tablets, nanosuspension, pediatric formulations, etc.) provide an easily scalable solution for difficult formulations in all development stages,” says Dr. Olmstead. “This differen­tiated, solvent-free, nano-granulation process for drug development and manu­facturing provides biotech and pharma­ceutical companies with a new solubility enhancement technology that has environ­mental sustainability, well suited for new drug development as well as life cycle management of commercial drugs.”

Pii, A Jabil Company: Delivering Agility When It Counts

 In silico modeling is changing how formulation development happens at Pii, a Jabil Company. “Instead of purely lab-based trial and error, our scientists use computational simulations to predict how drug candidates behave – how they dis­solve, interact with excipients, or degrade over time,” explains John Fowler, CEO, Pii, A Jabil Company. “This early insight helps reduce risks, saves valuable API, and fo­cuses lab efforts on formulations with the highest potential, speeding up develop­ment while improving confidence.”

On the manufacturing side, robotics play a growing role, especially in fill-finish operations for parenteral drugs, like ADCs and biologics. Automated systems bring speed, precision and consistency, reducing human error and contamination risk. Mr. Fowler says: “They allow for faster line changeovers and easier validation, which is critical when working with small batches or complex drug products. This dynamic manufacturing approach helps meet tight timelines and ensures product quality re­mains high.”

He says that what sets Pii, a Jabil Company, apart is the seamless integra­tion of drug and device development and manufacturing. Mr. Fowler explains that this combined capability simplifies supply chains and accelerates time to market – especially for complex combination prod­ucts like autoinjectors or prefilled syringes. “Having both drug formulation expertise and advanced device engineering in-house means we can collaborate closely to optimize product design, regulatory pathways, and commercial-scale manu­facturing,” he says.

Supply chain resilience is a key focus as well. The BioSecure Act and ongoing tariff uncertainties have pushed many to rethink where and how they source mate­rials. Pii leverages Jabil’s deep supply chain network and multi-source procure­ment strategies to mitigate risk. “Our on-shore and near-shore manufacturing sites keep critical processes close to patients, reducing delays and increasing oversight,” he says. “This approach supports regula­tory compliance and provides agility to navigate disruptions without sacrificing cost or continuity.” By integrating digital modeling, ad­vanced automation, combined drug-de­vice expertise, and strategic supply chain management, Pii and Jabil are shaping more informed, flexible, and reliable phar­maceutical development and manufactur­ing processes, claims Mr. Fowler. “It’s about making smarter decisions early and having the operational agility to deliver when it counts.”

Quotient Sciences: Using Technology to Bridge Studies & Formulations

Quotient Sciences has a breadth of formulation and manufacturing services for small molecules and synthetic peptides across a range of dosage forms. Matt Pa­terson, Chief Strategy Officer, says that Quotient Sciences’ Translational Pharma­ceutics® platform – a disruptive approach to drug development that integrates drug product formulation and manufacturing with clinical testing – sets the company apart. “The integration of services im­proves decision-making while reducing time and white space, so milestones can be achieved as efficiently as possible, shortening drug development timelines as a whole.”

Asma Patel, Vice President, Integrated Development Services at Quotient Sci­ences explains how the platform ad­dressed a product development challenge for one client. “We worked on a project for Rigel Pharmaceuticals, which was develop­ing R552, a small molecule RIPK1 inhibitor for autoimmune and inflammatory disor­ders. Preclinical data showed potential sol­ubility issues and, therefore, the client wanted to evaluate a range of formula­tions for the first-in-human (FIH) study. Leveraging the Translational Pharmaceu­tics platform, we conducted an adaptive FIH study to develop lipid and solid disper­sion (SDD) formulations to enhance solu­bility. These formulations underwent rapid, iterative testing, allowing for immediate adjustments and optimization.”

The study found that R552 was gen­erally safe and well-tolerated, with linear pharmacokinetics and no significant food effect. The SDD formulation proved effec­tive in overcoming solubility challenges. Bridging studies were then conducted to transition from a suspension to a more pa­tient-friendly SDD tablet formulation. “Using this approach, Rigel was able to achieve proof-of-concept milestones in a more streamlined and efficient manner,” she says.

Translational Pharmaceutics is com­monly used to bridge from simple formu­lations suitable for FIH studies to drug products that are scalable for proof-of-concept and later stages of clinical testing. To take this a step further, Mr. Paterson says Quotient Sciences also has an ongo­ing AI program aimed at improving deci­sion making and productivity in formulation design. “Combining our ex­tensive clinical experience and modelling and simulation expertise, the integration of AI will enable more informed and efficient decision-making, hence optimizing the formulation development process.”

Recipharm: Modeling Platform Accelerates Development

Recipharm has a fully integrated of­fering for drug substance and drug prod­ucts (for development and commercial supply), oral formulations, and sterile fill finish. Its complete offering ranges from API route scouting to commercialization.

Recipharm’s ReciPredict platform ac­celerates process development and tech­nology transfers. “ReciPredict combines statistical modelling and simulation to fa­cilitate product development, technology transfer and manufacture of drug products efficiently and reliably,” explains Dr. Uwe Hanenberg, PhD, Head of Product Imple­mentation, Recipharm. “It enables data driven, informed decisions by applying data science and digital technology to de­velop and manufacture drug products.”

ReciPredict was recently applied when Recipharm experienced a ‘sporadic’ Out of Specification (OOS) in the assay of a sterile liquid formulation in vials. Dr. Ha­nenberg says: “By translating the manu­facturing process and the analytical process into a mathematical model and using historical data to feed into it, we were able to identify and eliminate the root cause for the sporadic OOS.”

Resilience: Robust Data Platform Eliminates Inefficiencies

Resilience provides development and drug substance and drug product manu­facturing for biologics, vaccines, cell and gene therapy, and nucleic acids, hands-on support and regulatory guidance, and scale-up to commercial drug product manufacturing – all within North America. Resilience’s quality procedures and regu­latory experience safeguard BLA filings, prioritizing overall program success. Their network of facilities was designed to meet the highest industry standards, ensuring quality assurance and regulatory integrity that mitigate risks for its partners’ IND fil­ings and clinical trial timelines. They are ready to support new platform technolo­gies, process and analytical development programs, or drug substance or drug product manufacturing needs, while meet­ing timelines with dedicated capacity, and the ability to tailor resources to support in­novative projects.

The CDMO is witnessing growing de­mand in cell therapy, drug substance bio­logics, and sterile fill/finish for injectable products, particularly where downstream manufacturing and commercialization ex­pertise are critical. One especially promis­ing opportunity is the accelerating momentum behind GLP-1 therapeutics, which have expanded beyond diabetes management to include obesity, weight loss, and even conditions like sleep apnea.

Resilience has built a data platform that supports data processing and helps to increase efficiencies by streamlining cross-organizational communications between procurement, finance, supply chain oper­ations, project management, and more. The program interconnects 30 data prod­ucts across six domains, enabling near real-time reporting for more than 25 ap­plications and reducing human error by eliminating the need for manual data transfer and transcription.

“This allows us to provide a transpar­ent and centralized visibility of quality, ERP, lab, and process monitoring data to our clients in almost real-time and allows us to accelerate manufacturing timelines by re­ducing batch cycle times,” says Chuck Lemire, Vice President, Enterprise Systems, Resilience. “While currently used as an in­ternal tool, Resilience is now transforming our cloud-based capability into an app that clients can utilize to remotely and se­curely access their data, see the status of their program, and integrate to their own systems.”

Following tech transfer for develop­ment, a client approached Resilience with an incredibly tight timeline to produce a small drug substance batch. Their process was not yet very robust and was at risk for fairly routine failures, explains Mr. Lemire. The Resilience team was enlisted to fortify the process to help ensure the run would be successful so they could maintain their timeline.

“Utilizing our industry-leading Data Platform allowed us to monitor critical at­tributes in near real-time, with automated alerts for any trend towards out of specifi­cation,” he says. “Additionally, we synced video of the bioreactor to the data sets to provide our scientists immediate observa­tion into the operation. This empowered them to take action the moment an alert was sent. As we anticipated, there were is­sues during the run, however our team was able to intervene immediately and prevent any batch failure. Additionally, given the data sets recorded, we were able to provide development feedback to the client on how to improve their manufac­turing process further. Overall, the combi­nation of data, automation, and our experienced scientists facilitated successful completion of a critical asset and led to rapid improvement of their process.”

Samsung Biologics: Synchronizing Systems & Experience

Samsung Biologics adapts a stepwise screening matrix to find the best formula­tion condition. As biologic modalities evolve, the company continues to update that matrix by leveraging the scientific ex­pertise and experience of its formulation scientists.

“Our capabilities and technical readi­ness can cover liquid and frozen formula­tions as well as lyophilization for drug substance (DS) and drug product (DP),” says Heonchang Lim, Director of Formu­lation Development, Samsung Biologics. “Since the launch of our services, we have implemented around 100 projects for di­verse molecules – from monoclonal and multi-specific antibodies to Fc-fusions – and successfully formulated all of them.”

The growing molecular complexity of biologics has propelled Samsung Biologics to develop a data-driven approach to identify the ideal formulation type for each molecule. Its approach synchronizes cut­ting-edge systems and cumulative project experience. To further enhance the relia­bility and efficacy of the product, a tailored formulation strategy is developed with a high-throughput developability assess­ment. Additionally, a collection of data- driven insights – critical for issue identifi­cation, process traceability, and agile problem-solving – can be simultaneously implemented during formulation via sim­ple forced degradation studies upon client request.

Mr. Lim says: “Our formulation scien­tists are responsible for performing the de­velopability assessment, formulation development, and small-scale non-GMP DP manufacturing. The most critical re­sponsibility is development, as the primary goal is to attain optimal formulation con­ditions regardless of a molecule’s charac­teristics.”

Attaining a higher concentration can be challenging. Instability at high concen­trations, pH shifts, and viscosity issues can emerge at any stage of formulation. “Sev­eral months ago, we managed to achieve a concentration level of 266mg/mL, sur­passing the 200mg/mL target,” he says. “But, the pH condition was also adjusted to 0.51. Extrapolating a solution from our cumulative project experience, we promptly decided to leverage offset buffers to tackle the issue. The optimum, stable pH condition was achieved after imple­menting tangential flow filtration with the offset buffers.”

In terms of technological advances, Samsung Biologics leverages robot han­dlers – equipped with cameras that can identify visible particles, color, and turbidity – to reduce human error in formulation sample screening. A smart lab notebook system conducts robust data collection and analysis, adhering to good document practice standards. Generated data are recorded, sorted, and analyzed, enabling audit trails and process traceability tests.

Serán: Spray Drying Experience Makes or Breaks a Program

Developing complex molecules to treat human disease presents unique chal­lenges. Serán helps clients overcome these obstacles by offering a range of drug de­livery and formulation strategies designed to optimize bioavailability. Final dosage forms include capsules, tablets, multi-par­ticulates, and powder-in-bottle formats. Solid dosage forms are engineered to ad­dress solubility challenges and enable controlled or extended-release profiles.

“With decades of experience in parti­cle engineering, including advanced tech­niques like spray drying, Serán brings deep expertise to every stage of develop­ment,” says Rod Ketner, PhD, Serán. “Our solid-state analytical capabilities allow for thorough characterization of crystalline and amorphous APIs and drug products. These services are supported by compre­hensive analytical offerings and a GMP-compliant QC lab for release testing and stability studies.

Our strength lies in our scientific foun­dation, technical expertise, and collabora­tive team culture, ensuring smooth transitions from early development to commercial manufacturing.”

Serán focuses on the clients’ target product profile to make improvements in processes and delivery methods that help well-formulated medicines reach patients faster, says Dr. Ketner. “Innovation moves technology forward, but it’s our ability to apply proven strategies to new problems that drives success,” he says. “This is espe­cially critical with complex technologies like spray-dried dispersions (SDDs), where ex­perience can make or break a program.”

While known for spray drying and en­hancing bioavailability, Serán also sup­ports a range of conventional oral dosage forms. Dr. Ketner says: “Our focus is al­ways on choosing the simplest, most effec­tive solution tailored to the client’s molecule, the patient population, and their development goals.”

ten23 health AG: A Holistic Approach to Primary Packaging

ten23 health offers development serv­ices for sterile dosage forms for molecules such as biologics, peptides, oligonu­cleotides ADCs, viral vector, including for­mulation, process, and analytical development. Dr. Hanns-Christian Mahler, Chief Enablement Officer & Board Mem­ber, ten23 health AG, explains that the company’s formulation development ap­proach is holistic and includes the choice of primary packaging, and leverages rel­evant processes to ensure suitability and representativeness.

ten23 also provides manufacturing services for sterile drug products – from manufacturing of preclinical study material to stability study material to reference stan­dard. Isolator-based GMP filling lines process RTU primary packaging and pro­duce clinical to commercial sterile prod­ucts, including vials, syringes or cartridges.

Dr. Mahler is proud that ten23 health moves programs from development into GMP manufacturing, facilitating such (pos­sibly challenging) handovers for cus­tomers, that would otherwise transfer between CDMOs. “Our GMP manufactur­ing system is high-end technology, using robot-assisted filling of RTU containers, that, together with a clever choice of man­ufacturing processing materials and process, enables the precision of filling and stopper setting.

He describes a couple of instances where ten23 health has successfully helped clients with formulation challenges. “We have customers approaching us for specific issues they encountered with their formulations and process (developed else­where),” he says. “One was when the bio­logics API was precipitating upon dilution on sodium chloride bags. The prior formu­lation was developed closely to its edge of failure and with a focus of only ‘thermal stability,’ with the stabilizers having been diluted too much in the infusion bag. We supported an immediate ‘quick-fix’ solu­tion and embarked on developing a suffi­ciently robust, and usable formulation.”

In another example, ten23 health as­sessed polysorbate degradation, leading to particle formulation and non-compli­ance. The company supported trou­bleshooting of the customer’s process to improve product quality.

Upperton Pharma Solutions: Finding the Best Nasal Device for Your Formulation

Upperton provides comprehensive nasal formulation development services, covering both liquid and dry powder for­mats for multi-dose and single-dose deliv­ery. Capabilities include selecting the most suitable nasal device for a formulation from a range of options, ensuring optimal delivery performance, says Dr. Richard Johnson, Chief Scientific Officer & Founder at Upperton Pharma Solutions. Upperton also offers in-house characteri­zation of the final dosage form, including performance testing in nasal models such as the Alberta Idealised Nasal Inlet (AINI).

“Our team has deep expertise in par­ticle engineering, enabling us to develop and manufacture dry powder formulations for nasal delivery – especially relevant for biologics, peptides, and vaccines,” he says. “A key differentiator is our work at the forefront of nose-to-brain delivery, includ­ing partnerships involving proprietary de­vices in this emerging area. This work builds on our broader experience across other challenging dose forms, such as oral solids (tablets, capsules), pulmonary (sin­gle- and multi-dose), and sterile injectable liquids and powder products.”

Clients developing dry powder nasal products face a challenge when scaling up from milligram to gram and eventually kilogram-scale production at a time when API supplies are likely to be limited, he ex­plains. This is particularly challenging as particle size and morphology needs to be maintained at all stages of development. “In one case, we addressed this by apply­ing a stepwise scale-up strategy using our spray drying technology and expertise, al­lowing us to match particle specifications at small and intermediate scales,” says Dr. Johnson. “This approach enabled us to manufacture small batches for early test­ing and seamlessly progress into the clinic. The outcome was faster clinical entry, with a scalable process that consistently deliv­ered the same particle quality – batch after batch.”

Over the last two years, several high-profile products, such as Neffy, approved by the FDA in 2024, have demonstrated that drugs traditionally delivered by injec­tion can be effectively administered nasally, says Dr. Johnson. “This shift has sparked significant interest in nasal deliv­ery, especially for emergency-use and treatments that require fast-onset of ac­tion,” he says. “As a result, we’ve seen growing demand for early-phase formula­tion development, particularly for Phase 1 and Phase 2 programs. Companies are increasingly exploring nasal routes for bi­ologics, peptides, and other small mole­cules, driven by the potential for improved patient compliance, rapid onset, and non-invasive delivery. This trend is also pushing more of these types of projects into late-stage manufacturing.”

Upperton has introduced automated device filling capabilities using Fill2Weight tech­nology, which allows for precise and consistent filling of nasal delivery devices – both liquid and powder formulations. This system ensures high fill accuracy and efficiency, especially important for single- and multi-dose nasal products. On the as­sembly side, Upperton is expanding capabilities to support semi-automated and automated as­sembly of nasal devices, including integration of components and in-process checks. He says: “These technologies help us maintain tight quality control, reduce manual handling, and support scalable manufacturing as products move into later phases.”

Reference

1. Pharmaceutical CDMO Market Set to Surpass $315.08 Billion by 2034, Driven by 7.24% CAGR, GlobeNewswire, May 6, 2025, https://www.globenewswire.com/news-release/2025/05/06/3075216/0/en/Phar­maceutical-CDMO-Market-Set-to-Surpass-315-08-Billion-by-2034-Driven-by-7-24-CAGR.html.