SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Meeting Demand for Biologics & Specialty Drugs
Increasing patent expirations of major drugs, the growing burden of chronic diseases, and elevated global awareness of vaccines are leading to a surge in outsourcing formulation development services. Industry experts say these trends put a value on the global pharmaceutical CDMO Market at $160.12 billion in 2020, and could reach $236.61 billion by 2026,1 while the North American CDMO market is expected to reach $101.1 billion by 2030.2 As more pharma/biopharma companies opt to partner with CDMOs, much of this activity is occurring in the early phase of development with the goal of overcoming risk, along with saving time and money as a drug passes through the development pipeline.
This annual Drug Development & Delivery report highlights the formulation development and manufacturing offerings from some of the leading CDMOs to address a myriad of challenges – from complex compounds to poor solubility to dual-release profiles.
Adare Pharma Solutions: Formulating Child-Friendly, Broad-Range Dosing
A European-based pharmaceutical company wanted to improve its pancreatic enzyme product (PEP) delivery to patients who have difficulty swallowing several capsules a day, especially children with cystic fibrosis (CF) and other conditions. Providing a broad dosage range for optimal symptom control and precise dosing was also a requirement.
Adare Pharma Solutions scientists paired the API with Adare’s MMTSTM
Minitabs technology as it can be sprinkled onto soft foods (<5pH). Adare was also able to expand the dosage range to 40,000 USP units.
“This method has been proven effective, safe, and well-tolerated in treating pediatric CF patients (ages 1-6 years old) in a Phase 3 pediatric study, and a broad dosage range from 3,000 to 25,000 USP units was also proven,” says Luigi Boltri, Senior Director Pharmaceutical Sciences, Business Support & New Technologies, Adare.
In another situation, a particularly bitter pediatric macrolide in powder form was brought to Adare for needs beyond just taste masking. The API also needed fast release due to a narrow absorption window, a smooth syrup mouthfeel acceptable to children and infants, more than 7 days of taste masking after suspension, and drug loading suitable for its high dose.
Adare scientists paired the API with its Microcaps® taste-masking technology platform and coated with a pH-dependent polymer.
“Rapid release was demonstrated in vitro and in vivo, achieving the targeted bioequivalence,” says Mr. Boltri. “The API’s particle size distribution (in the range of 100-200μ) remained virtually the same minimizing any possibility of a gritty mouthfeel while also achieving over 10 days of taste masking in extemporary suspension. A high drug load of up to 70% was also achieved.”
According to the Food and Drug Administration and the Orphan Drug Designation program, orphan status applies to drugs and biologics defined as “those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the US, or that affect more than 200,000 people, but are not expected to recover the costs of developing and marketing a treatment drug.” Due to the high costs and low demands of the drug product, it is important to efficiently use API supply during the formulation process.
Dr. Elsie Melsopp, Head of Solids Formulations for Alcami, says the company successfully helped a client overcome an API supply shortage using Quality by Design (QbD) studies to successfully formulate an orphan drug product. The client needed full development and product readiness with an extremely short supply of the API. In addition, the scale-up batch was small because of the low volume of product demands of their orphan drug.
Considering that small batches present a challenge in proving robustness of the processing equipment, the Alcami project team, in collaboration with client team members, prepared a failure mode, effects, and criticality analysis (FMECA) of the formulation and process. As a result, the team identified and prioritized studies that would provide the necessary product and process understanding needed to develop a control strategy, ensure the reproducibility of the product, and meet its intended safety, efficacy, stability, and performance profile regardless of the manufacturing scale.
The QbD studies were designed concisely to minimize the use of the API and evaluate the critical product parameters that could affect the product quality attributes of the drug product, per FDA’s QbD guidance.
“Alcami supported this product with supply constraints and successfully developed a capsule formulation for two dosage strengths,” she explains. “The formulations group performed studies at a micro-laboratory scale using a scientifically-based approach to identify a lead prototype. The results provided a formulation amenable to two dosage strengths by applying a proportional dosing weight method.” The product is currently in late-stage development with the New Drug Application filing expected late 2021.
Increased complexity in dosage form design has led many to work with a specialty CDMO to resolve compound issues, accelerate the product development timeline, and reduce cost in development and manufacturing.
As a CDMO, Ascendia has invested heavily in drug delivery technologies, such as EmulSol, NanoSol, and AmorSol, which are versatile for use in delivery of small molecules, biologicals, and large molecules. “Our technologies can cover almost all new compounds with different challenging properties (BCS II, III, IV and biologicals); we have generated 6 patents using our technologies in house or for our clients,” says Jim Huang, PhD, CEO, Ascendia Pharmaceuticals.
He explains how one client was in search of a specialty CDMO for complex sterile injectable nanosuspension for an unstable compound. “Using NanoSol technology, we were able to develop a stable sterile suspension by controlling the impurity generation during manufacturing process, resulting in a transition to a proof-of-concept study in a timely matter.”
Ascendia is also expanding its GMP capacity for discovery to later stage development of sterile and non-sterile dosage forms.
August Bioservices: Late-Stage Trial Services
According to Marty Henehan, Vice President of Commercial Development for August Bioservices, a US-based CDMO with formulation and manufacturing expertise, the benefits for pharma companies partnering with CDMOs for clinical and commercial-stage manufacturing are several-fold. “First and foremost, it is important to remember that late-stage clinical trial products are being used to treat real people – to confirm the drug is safe and effective, to assess any potential side effects, and to compare the drug being evaluated to current treatments. Therefore, the stakes can’t be any higher from a human care perspective.” Mr. Henehan adds that pharma companies who have reached the later phases of the clinical trial process have painstakingly managed their development processes over several years and want to avoid making a preventable mistake so late in the game.
As product pipelines are expanding industry-wide to include generics, biosimilars and biologics, new technologies and capabilities are being required of CDMOs to support the unique formulation and manufacturing specifications of these molecules. “August has experience formulating, manufacturing, and launching products in the finished dose pharmaceutical industry – both branded and generic – with a strong focus on injectables across a multitude of presentations (prefilled syringes, vials, IV bags),” he says.
He adds that August has state-of-the-art instrumentation and more will be added in a 2021 expansion project and a 2023 new facility build. “We currently have a high-speed vial line and we are adding a prefilled syringe line, an IV bag line, lyophilization, and terminal sterilization capabilities this year. On the analytical side, we also have an Extractables and Leachables testing program, in addition to formulation and analytical services.”
As an experienced provider of fill-finish services, Baxter BioPharma Solutions’ laboratory is well-equipped to evaluate formulations containing a biologic, evaluate the physical behavior of lyophilized formulations, and to isolate and identify particles. One of the instruments utilized for studying lyophilization is the tunable diode laser absorption spectroscopy (TDLAS) for analyzing the flow of water vapor from the product chamber to the condenser. The data from TDLAS is used to develop a primary drying design space. The instrument is also available for use at full-scale. Three of the lyophilizers are capable of controlling ice nucleation for studying the effect of freezing conditions on drying time and product quality.
Wendy Saffell-Clemmer, Lead Scientist/Research and Development, Senior Director at Baxter BioPharma Solutions shares an example of a successful resolution of a problem that occurred during manufacturing a lyophilized product that exhibited severe vial fogging. “Lyophilized formulations can exhibit dried solution above the surface of the dried cake and the dried solution can appear in the area of the vial where the stopper seals in the neck,” she says. “This not only affects appearance, but can be a risk to quality assurance.”
The reason for vial fogging is not entirely clear and can be random, she adds. Some risk factors are the presence of a surfactant and the variability in vial surfaces. A product manufactured for one client often appeared with low levels of vial fogging. However, one batch exhibited more than 90% of vials with severe fogging that reached into the neck of a vial. The Baxter Research and Development laboratory studied the effect of different vial types on the extent of fogging and helped the client identify a vial that worked well with their product. The product returned to full-scale manufacturing using the new vial that has a hydrophobic surface and no fogging occurred on any of the vials.
CycloLab: Cyclodextrin-Based Formulations
CycloLab Cyclodextrin Research & Development Laboratory Ltd. develops improved formulations of low water solubility and poor bioavailability by applying various cyclodextrins. As a result of cyclodextrin complexation, the pharmacokinetic parameters of these “guest” compounds may become significantly more favorable, says Dr. Istvan Puskas, Research Chemist at CycloLab. “Compared to traditional drug formulations, wherein a surfactant and/or a co-solvent is applied for the same purpose, using cyclodextrins is still regarded as an inventive approach.”
When an innovator applies to get approval for a new cyclodextrin-based composition of a known drug compound, the question of bioequivalence is raised by the pharmaceutical authorities even for injectables, he explains. The innovator must demonstrate bioequivalence of a classically solubilized composition to a complex, cyclodextrin-based formulation. Traditional animal studies to justify bioequivalence are demanding in terms of cost, duration of test, and documentation, including sensitive ethical issues. To bypass this difficulty, biowaiver data such as in vitro permeation studies are often found just as convincing as in vivo results in the approval process, says Dr. Puskas.
CycloLab conducts comparative simple and reliable in vitro tests using a reference marketed product and an innovative cyclodextrin-based formulation regardless if the new composition is developed by CycloLab or previously elaborated by the study sponsor. By conducting in vitro permeation studies, the customer may get insight into the physical state of the dissolved drug in simulated biological fluids or in human plasma. By analyzing the permeation rates of the drug from the reference marketed product and from the cyclodextrin-based complex through different semi permeable membranes, the justification of bioequivalence might be established. The method is based on the discrimination of free and cyclodextrin or protein bound portion of the drug substance.
To further illustrate the nature of drug-cyclodextrin interactions, computer modeling on the noncovalent association, aggregation studies in different dilution states may be performed. In addition, competitive cyclodextrin binding studies are provided in human serum albumin as well as in whole plasma. CycloLab’s study report on the experimental data is issued ready for submission to relevant authorities to support the approval process.
In 2020, Emergent announced a $75 million investment into its Canton, Massachusetts drug substance facility to increase the campus footprint and expand its manufacturing capabilities into viral vector-based gene therapy. The investment includes a state-of-the-art, multi-suite operation up to 1000L in scale. The expansion will bolster Emergent’s integrated CDMO service offering for development and manufacturing of viral vector-based gene therapies.
“Emergent’s extensive experience in viral vectors and vaccine development provides a solid background in the capabilities and know-how needed for the scale-up and production, in addition to the processing and purification of cells and viruses for advanced therapies,” says Catherine Hanley, Vice President & Interim CDMO Business Unit Head, Emergent BioSolutions.
A new Groninger® FlexPro 50 filling suite located at the Emergent Camden Drug Product facility in Baltimore enhances capabilities for aseptic fill/finish processing. The FlexPro 50 utilizes isolator-based technology for aseptic processing of pre-sterilized syringes, cartridges, and vials, and can support liquid or lyophilized products, says Ms. Hanley.
Additionally, a viral drug product facility in Rockville, Maryland is currently undergoing a 58,000 sq. ft. expansion that will include a state-of-the-art high speed fill/finish line with fully integrated isolator technology and an automated inspection, labeling and packaging line, enhancing capabilities in large-scale fill/finish manufacturing of viral biotherapeutics and vaccines.
Finally, the Winnipeg, Manitoba, Canada development and manufacturing site houses a state-of-the-art Vanrx® SA25 Aseptic Filling Workcell. “This provides our clients with a high level of sterility assurance through an automated handling, filling, and closing process, designed to minimize line losses.”
Lubrizol Life Science Health (LLS Health) recognizes a growing need for aseptic manufacturing capacity that can bridge the gap from clinical to commercial scale and accommodate complex processing steps. To this end, the company has continued to invest in its proprietary SteriMillTM technology, which enables aseptic nanomilling for nanoparticulate suspensions suitable for parenteral administration (such as intravenous injection), long-acting injectables, and ophthalmic formulations. The SteriMill platform is one of several solubility and bioavailability enhancement techniques that Lubrizol deploys.
LLS Health has also invested over $10 million in its commercial manufacturing facility, building upon its decades as a clinical GMP manufacturer and allowing Lubrizol to partner with clients as they go to market. The commercial facility opened in 2019 and features 6,000 sq. ft. of purpose-built processing space to scale-up products that employ nanomilling or other formulation steps prior to filling. LLS Health’s ISO 5 filling line is equipped for 2-30mL fills in vials, and the company is also bringing its clinical experience with ophthalmic bottles to the commercial space. The first pre-approval inspection of the site will take place in the second half of this year, positioning LLS Health to support existing clients and new projects in need of commercial production, says Robert Lee, PhD, President, CDMO Division of LLS Health.
A client reached out to LLS Health looking for technology to improve oral delivery of a poorly water-soluble API and provide intellectual property protection of their asset. After brainstorming with the client, Dr. Lee says LLS Health applied its patented LyoCell® technology to develop a formulation with high drug loading, taste masking, and a manufacturing process that could be scaled for use in an oral liquid formulation.
“LyoCells are lipid-based particles that possess powerful drug-solubilizing properties and are compatible with a variety of APIs, whether small molecule or biopharmaceutical,” he says.
LLS Health is currently scaling the LyoCell manufacturing process to thousands of liters of concentrate that will be incorporated into the client’s final product. The scaled manufacturing process will be transferred back to the client for future production.
Metrics Contract Services: Mitigating Time, Cost, & Risk
To enhance services at Metrics, the company has continued to invest in the single campus model where a dosage form can go from initial concept to global commercial supply under a single FDA registration. Technology transfer will always add cost and take more time. “To mitigate cost, time and risk, we believe in offering scale-up solutions in like-equipment and the benefit of team continuity under a common quality system as a sponsor’s product navigates the clinical pathway to commercialization,” says John Ross, President, Metrics Contract Services.
A client came to Metrics needing to convert a drug-in-capsule to a formulated capsule for a Phase 2a clinical study. The drug was highly potent and moisture sensitive, requiring %RH of less than 30% at all times during handling and manufacture, explains Brad Gold, PhD, Vice President, Pharmaceutical Development, Metrics Contract Services.
Given the high potent banding, development and manufacture had to occur behind hard-wall isolation. Use of HEPA-filtered inlet and outlet air would be required. The idea of combining clean/dry compressed air, with ultra-low moisture contribution as ‘make-up’ for some inlet air, was presented and engineered, as a solution.
Dr. Gold says Metrics demonstrated, through several dry runs, that this approach was a good solution to controlling humidity levels inside a containment isolator. “Formulation prototypes and clinical trial material were manufactured successfully, with state-of-the-art control for operator exposure. Moreover, the critical quality attribute of humidity level during manufacturing was addressed, as Metrics was able to effectively operate its high potent containment isolators with acceptable differential pressure, while simultaneously controlling %RH to under 30%.”
For the past decade, Quotient Sciences has created a delivery platform that integrates drug product and clinical testing activities to achieve program acceleration. To support this further, Quotient recently acquired Arcinova, the UK-based CDMO, because of its expertise and capability in early-stage drug substance and bioanalysis work.
“We see a great opportunity for investing in and integrating drug substance services into our existing drug product and clinical testing platform,” says Sarah Stevens, Vice President Drug Development Sciences, Quotient Sciences.
Drug substance manufacturing often sits on the critical path in early development with drug product manufacturing and clinical trial initiation routinely suffering from late API supply, she says. As one of the major causes of project delays, it is important for biotech companies to work closely with API manufacturers early in the development process to ensure the drug substance is not only supplied on time, but that potential formulation or downstream challenges have also been identified or flagged up front.
“The investment in this capability will enable the integration of drug substance, drug product, and clinical testing capabilities – all under one organization with a single Project Management function,” she says.
In this environment, chemists work hand-in-hand with formulators and biopharmaceutics experts, sharing information about the properties of the molecule and troubleshooting formulation strategies. Drug product manufacturing scientists work alongside clinical teams, ensuring that the needs of the clinical trial and patient groups are met.
She says: “This will cut through more industry silos by combining a range of drug development capabilities, creating additional timeline savings for our clients and ultimately helping to get new drug molecules to patients, faster.”
Recipharm is continuously looking to improve its aseptic fill-finish capabilities for sterile liquids, and lyophilized products, says Torkel Gren, Science & Technology Officer. “This will be important for a lot of biologics and biosimilars because the two important characteristics of most biomolecules are that they have none or very low bioavailability and their stability is limited. This means that they have to be administered by injection and, in many cases, lyophilization is needed to get a product with acceptable shelf life.”
Recipharm is also working to in crease its dedicated manufacturing capability for small batches of GMP drug substances in addition to large batches for commercial.
“We are committed to providing the infrastructure and capacity to support customers through the drug substance and drug product development process to bring these innovative small-molecule treatments to clinical trial,” he says. “With our investment, we will continue to support customers in both areas as a single, integrated supplier, minimizing delays from tech transfers between partners.”
One customer recently approached Recipharm for help repurposing some registered drug substances as fixed-dose combination for a new indication. To achieve the right effect, one of the ingredients had to be delivered through modified release. “We proposed delivering one of the API in minitablets and the other in coated pellets; the minitablets and pellet were then filled into capsules,” Mr. Gren explains. “This approach avoided incompatibilities between the substances and provided both immediate and modified release. Moreover, the proposed technology allowed the drug-containing components to be adjusted independently of each other, minimizing development timeframes.”
Recro: Investing in Oral Solid Dose Development
Recro continues to strategically invest in new capabilities to serve the needs of the oral solid dose pharma industry. Supply chain disruption risks and the re-onshoring movement have prompted many companies to look for US-based CDMOs and CMOs for either primary or second source development and manufacturing. To serve this growing need, in the past year Recro added various capabilities and service offerings.
“One of our clients came to us with a risk mitigation and supply chain security plan for one of its commercial products,” explains Richard Sidwell, Vice President and Chief Scientific Officer. “They preferred a US manufacturer mainly to have a secondary source, but it was also crucial to have improved distribution in their critical market. We saw this as an opportunity to install larger-scale equipment and expand our high shear granulation and fluid bed capabilities.”
In 2020, Recro completed the construction of two new processing rooms and installed a Freund-Vector VFC-120MX Flo-Coater fluid bed as well as a Freund-Vector GMXB-400 high shear granulator. Both of these installations are now fully qualified and in use for client projects.
Another client had a need for a multiparticulate capsule with a high drug load. The challenge was that the API appeared to exhibit unusual physical behavior in the drug layering suspension formulation, explains Dr. Sidwell. “We suggested performing a series of small-scale suspension preparations and film casting to identify a formulation that would enable a path forward for the drug-layering process. After several quick experiments, we confirmed the behavior we were seeing was related to a physical drug-excipient interaction that happened in the presence of water. By careful selection of excipients and process solvents for the spray suspension, we were able to resolve the issue and successfully produced the desired drug-loaded pellets.”
Abzena: Expediting Timelines in Formulation & Manufacturing
When one of its partners required a formulation to support long-term storage for early-phase clinical studies and had no manufacturing capabilities or formulation experience, they turned to Abzena. An additional challenge was very low drug substance available. “To overcome the challenges, we suggested a large formulation screen and a pre-formulation study to accelerate and refine the candidate selection,” describes Campbell Bunce, PhD, Chief Scientific Officer of Abzena. “A 50% improvement in stability was seen in the lead and backup formulations when compared to our partner’s control.”
These results led to the partner discontinuing their preferred excipient and adopting the new formulations. As both lead and backup were similar, the client decided to combine the technologies used in both formulations and utilized this in development of their product. The formulation was also patented, helping to secure the IP and commercial rights of this lead candidate.
In addition to formulation studies, Abzena has invested in optimizing analytical workflows that support selection of the best, de-risked lead drug candidate to progress to development and manufacture, says Dr. Bunce. This extends into development of a new cell line expression platform that allows material to be produced very early to truncate development timelines. The expedited timelines are achieved using the material for analytical method, formulation, and downstream development.
“It is important to invest in breadth and depth of skill sets around a diverse range of mammalian expression systems that align with the older cell lines used for out-of-patentbiologics, as well as modern systems with improved productivity,” he says. “This allows versatility around supporting biosimilar and novel biologics manufacture and it is critical to respond to the global demand, across a range of therapeutic areas. This not only extends manufacturing capacity, but ensures flexibility around scale of manufacture and constant innovation around processes to shorten timelines.”
Aurigene Pharmaceutical Services: Pellet-Filled Capsule for Dual-Release Formulations
Early clinical phase formulations are often simple powders, granules, drug-filled capsules, or injectables. It can become challenging when a modified-release product needs to be developed for preclinical and first-in-human studies. Limited availability of the drug substance, the requirement of flexibility in dosing, and tight timelines are major challenges for such projects. Aurigene Pharmaceutical Services (formerly Dr. Reddy’s CPS) has had quite a few of these experiences. One is a highly water-soluble, high-dose drug that needed a modified-release profile with two components: immediate release and slow release.
“The small biotech that approached us had worked with another CDMO for early development and developed polymer-coated tablets,” explains Rashmi Nair, Director, ROW Business at Aurigene Pharmaceutical Services. “However, for dose-ranging studies, they were planning to evaluate six doses in clinical Phase 1 trials. Making six tablet strengths and optimizing each of them was a herculean task and neither cost nor time-efficient. When we took up the project, we decided to work backward from the therapeutic rationale of the product, the competitive landscape of marketed or other clinical programs, and a formulation that could be closer to a commercial formulation.”
Aurigene designed a pellet-filled capsule formulation. Immediate-release pellets and slow-release pellets were manufactured separately through the Wurster coating process, which is easily scalable, says Ms. Nair. A rotary filling machine filled these pellets into capsules. “By varying pellet fill, we created different doses from 20mg to 200mg. The beauty of this formulation was that we could use the same formulation for the clinical Phase 1 and 3 studies.”
For commercial manufacturing, the formulation was the same, the process was modified with high-speed guns for Wurster coating, and to prevent static charge and agglomeration, a pure steam generation step was introduced during polymer coating.
Today, this is a commercial product. A life cycle extension product was created by utilizing the same slow-release formulation and adding another drug as immediate-release granules.
Genezen is a CDMO entirely focused on cell and gene therapies, with specific expertise in lentiviral vectors. The company has recently received a growth equity investment from Ampersand Capital Partners. The funding is being used to build an initial 25,000-sq. ft. cGMP-compliant lentiviral vector production facility as part of a multiphase master plan for the development of a 75,000-sq. ft. site. The site will offer multiple cGMP production suites, including capabilities for host cell expansion, host cell banking, and viral vector production via transient transfection and producer cell lines.
Genezen will also deliver a full suite of process development capabilities to support cGMP and commercial readiness, upstream and downstream process improvements, research grade and preclinical vector production, and analytical assay development and validation from the site. “Capabilities to develop producer cell lines will help reduce dependence on GMP-grade plasmids, an investment in state-of-the-art closed systems will ensure safety of the product and reduce risks of human error, and in-house QC assays will speed release testing,” says Pratima Cherukuri, Chief Scientific Officer at Genezen. “This single-campus approach is increasingly appealing for pharma companies as it de-risks development and scale up.”
She adds that the new site offers fixed-bed bioreactor technology, enabling Genezen to offer a closed lentiviral vector production platform culminating in aseptic fill-finish of vector products into sterile bags for use in cell therapy. The site will also build on existing adherent platforms (cell stacks and fixed-bed bioreactors) and refine existing suspension platforms to offer improved scaling for larger production volumes. Analytical testing services, including unique Recombinant Competent Lentivirus assays (extended culture and PCR methods) for end-of-production release and patient sample testing are also available.
Idifarma: A Focus on Complex & High-Value Drugs
Idifarma has implemented several technologies to provide a comprehensive service for the development and manufacture of Dried Powder Inhalers (DPIs), including spray drying and encapsulation, and has agreements with various relevant entities for the use of the latest technologies for the characterization of DPIs, says Alfredo Gomez, Head of Site at Idifarma.
“We continue to invest in spray drying technology for highly potent drugs,” he says. “Our focus on complex and high-value drugs has recently led us to invest in a software tool for a continuous control system of the process to analyze as many parameters as possible, for a complete guarantee of compliance with specifications as well as for rapid process optimizations.”
Samsung Biologics: Expanding Capacity for End-to-End Support
Samsung Biologics assist clients with developing and manufacturing product pipelines in an expedited timeline. The CDMO has been maximizing operational efficiency and expanding capabilities for end-to-end outsourcing support, and its latest efforts include the construction of a fourth plant, which, upon completion, will give Samsung Biologics a 620KL of total capacity.
Samsung Biologics also continues to upgrade its capabilities to accommodate clients by investing in single-use technology and additional aseptic filling capacity. In addition, the opening of a new R&D Center in San Francisco expands the company’s global presence, says James Choi, Senior Vice President and Chief Information and Marketing Officer, and Head of Investor and Global Public Relations, at Samsung.
To enhance its development services, the company has launched a proprietary cell-line, S-CHOice, which facilitates high performance to enable rapid advancement to IND approval. Samsung Biologics continues to support traditional fed-batch manufacturing by implementing N-1 perfusion technology at the cell culture stage to accommodate rising demand in the latest technology that enhances cell density.
Stelis Biosource: New Manufacturing Technology for Lyophilization & Viral Vectors
Stelis Biosource has expertise in biosimilars as well as vaccines and other biotherapeutics. The company is focused on growing its capacity, capabilities, and knowledge to scale up in the cell and gene therapy space. According to Dr. Anand Khedkar, Sr. Vice President, R&D, Stelis Biosource, the company is investing in various manufacturing platforms for both drug substances and drug products.
“We already have microbial and mammalian platforms and are about to commission a viral vector manufacturing platform,” he says. “We are also in the process of researching and integrating other platforms to help bring new kinds of therapeutic products to the market. On the drug product side, we have invested in high-speed vial lines, a high viscosity prefilled syringe filling line as well as a cartridge filling line. We have created dedicated facilities for viral vaccines, high viscosity products, monoclonal antibodies and other products. We also have the capability to manufacture lyophilized vials.”
Vibalogics: Manufacturing Viral Vector Vaccines & Gene Therapy
Global demand for CDMO services is at an all-time high, fueled by broadening biologics pipelines. Vibalogics is investing in global infrastructure expansions in both the existing clinical cGMP facility in Germany and the establishment of a new US facility in Massachusetts. Driven by a $150 million investment and a 110,000 sq. ft. facility, Vibalogics will enable the market with further contribution to the overall global supply of manufacturing services for oncolytic viruses, viral vector vaccines, and viral vector gene therapy products, says Joe Sinclair, VP of Business Development & Corporate Strategy for Vibalogics. “We are preparing for the future expansion of this space with a complete suite of virotherapy services and end-to-end service solutions,” he says.
Investment in both novel and widely-utilized production and analytical platforms has enabled Vibalogics fit-for-service across a broad class of products and range of customers’ needs in viral production, he continues. Modular design and multi-product considerations within the facilities enable a variety of products and processes. Emerging trends in utilizing suspension cultured cell substrates and a need for larger capacity has driven Vibalogics to invest in state-of-the-art technology, such as 2,000L scale bioreactors, with ongoing evaluation of platforms at 4,000L and higher.
Vibalogics is also heavily focused on plant design considerations and process capabilities to allow for aseptic production routinely required for viruses of larger size that cannot be sterile filtered. S
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