The global prefilled syringes market (PFS) is poised for substantial growth, with an estimated valuation of $10 billion in 2026, expected to reach $19.3 billion by 2033, driven by rising demand for biologic drugs, increasing prevalence of chronic diseases, and the growing adoption of self-administered drug delivery systems.1 While conventional PFS dominate the sector, there is growing interest in dual-chamber PFS – freeze-dried drugs and diluents in separate chambers – necessitated by precise and convenient medication administration. In addition, the growth of the biopharmaceutical sector, particularly in biologics and biosimilars are fueling the need for specialized delivery systems such as dual-chamber prefilled syringes, which ensure the stability and proper administration of complex medications to treat chronic diseases. Thus, a market valued at approximately $199 million in 2026 could reach $334 million by 2033.2

As the market swells, so too do CDMO expansions to accommodate the growth in parenteral manufacturing. Over the last year, several CDMOs are proceeding with capacity additions to existing locations and building new sites. This annual Drug Development & Delivery report highlights many of these CDMOs as well as innovations in the PFS sector.

Aptar Pharma: Closure Performance for GLP-1 & Sensitive Biologics

The injectable market’s center of grav­ity has shifted. Where formulation complex­ity was once the primary design constraint, today’s drug developers must contend with the full system: a high-concentration bio­logic sensitive to primary packaging con­tact, a subcutaneous self-injection that demands predictable gliding forces for au­toinjector integration, a vaccine formula­tion that cannot tolerate cold-chain excursions. Primary packaging components sit at the intersection of all of it.

“Highly sensitive drugs are shaping today’s injectable landscape across the entire lifecycle, from formulation to patient administration,” says Olivier Simon, Global Business Development Director at Aptar Pharma. “That’s the environment for which Aptar Pharma designs.”

Aptar Pharma’s answer is Premium­Coat® – a coated closure platform span­ning plungers for prefilled syringes, plungers for cartridges, and stoppers for vials, unified by a single rubber formula­tion (6720GC Bromobutyl) and a consis­tent ETFE film. The material consistency is deliberate: where separate qualification programs would otherwise be required for each container type, a common platform lets developers transfer learning across formats rather than rebuilding it from scratch, he explains. With cartridge for­mats for large-volume subcutaneous de­livery added recently to the portfolio and cross-platform compatibility data continu­ing to accumulate, PremiumCoat is de­signed to grow with the pipeline it serves – across biologics, vaccines, and self-ad­ministered injectables.

Mr. Simon presented performance data at the 2026 PDA Parenteral Packag­ing Conference. Force profile studies on the 1mL long plunger – conducted across three syringe platforms, three batches, and accelerated stability conditions out to 12 months at 40°C – demonstrated stable, low break-loose and gliding forces with minimal inter-syringe variability. Viscosity testing extended this further: at diverse and realistic CP values, injection forces re­mained within ranges considered achiev­able for patients with rheumatoid arthritis, a relevant benchmark for immunology and other high-concentration biologic in­dications, he explained at the conference. Machinability testing across vacuum and vent tube stoppering equipment from three machine makers confirmed ETFE film in­tegrity post-insertion – a practical consid­eration that frequently surfaces late in fill-finish development.

“The question we keep coming back to is how closure design enables consistent delivery performance across the drug-de­vice-patient ecosystem,” says Mr. Simon. “That framing keeps us focused on what actually matters to our customers, not just the component in isolation, but how it per­forms in the system.”

BD Pharmaceutical Systems: Advancing Development with Reduced Risk

BD Pharmaceutical Systems provides primary drug containers and delivery solu­tions for injectable and parenteral drugs, as well as advanced drug delivery systems and services (ZebraSci) to support end-to-end system needs. With a focus on glass prefillable syringes (PFS) and integrated systems, the PFS portfolio is designed to support drug development from early clin­ical phases through commercial scale while reducing risk across the drug life cycle, explains Mehdi Megdoud, Global Marketing Director, Prefillable Syrings, BD.

The key needs BD Pharmaceutical Sys­tems aims to address are: drug-container compatibility for sensitive biologics; in­jectability challenges linked to higher vis­cosity and larger volumes; reliability, quality, and supply resilience at commer­cial scale; and combination product readi­ness, including autoinjector and delivery device compatibility. To support biologics/biosimilars, vaccines, and self-administered chronic therapies, BD offers:

• BD Hypak™ for Biotech and BD Neopak™ Glass Prefillable Syringes designed for compatibility with sensitive formulations;
• BD Neopak XSi™ Glass Prefillable Sy­ringe, featuring a proprietary cross linked silicone coating to reduce sub-vis­ible particles without introducing new chemistry; and
• BD Neopak XtraFlow™ Glass Prefillable Syringe developed to improve flow per­formance for higher viscosity drugs and larger volumes by reducing pressure drop during injection.

“These container solutions are com­plemented by technical documentation, stack up analysis, and early development support to de-risk regulatory and scale up phases,” he says.

Raising the bar for PFS solutions are cell and gene therapies and antibody drug conjugates by introducing higher drug sen­sitivity to surfaces and particulates, smaller batch sizes with very high value per dose, and increased formulation complexity, in­cluding viscosity and stability constraints, explains Mr. Megdoud. As a result, this is driving demand for enhanced glass sur­face control and coatings to mitigate par­ticulate and compatibility risks, precision manufacturing and tighter specifications, and early, collaborative container-closure evaluation during development.

“As a result, PFS are no longer viewed as commodity components but as critical elements of the overall drug product de­sign,” he says.

BD frequently partners with pharma­ceutical companies facing challenges re­lated to injectability of high viscosity biologics in larger volumes. In one repre­sentative collaboration, a pharma partner experienced long injection times and high injection forces when progressing a viscous biologic into a PFS-based combination product. BD supported the program through early technical engagement, in­cluding injectability testing, and container–device compatibility assessments, Mr. Megdoud explains. The program lever­aged BD Neopak XtraFlow Glass Prefill­able Syringe, designed to improve flow performance while maintaining compati­bility with autoinjector platforms.

He says: “This approach helped our partner advance development with re­duced technical risk, improved patient us­ability targets, providing greater confi­dence ahead of scale-up.”

Bora Pharmaceuticals: PFS for Rare & Orphan Diseases

As demand grows for more complex, innovative therapies, the pressure to de­liver them safely and efficiently is driving new expectations for drug delivery systems, like prefilled syringes (PFS). In fact, PFS have become a critical part of how these therapies reach patients.

Bora Pharmaceuticals’ facility in Balti­more, MD, specializes in PFS products for a variety of therapeutic areas, including for rare and orphan diseases. Shipping prod­ucts to more than 40 countries, the 87,000-sq. ft. site provides full service, end-to-end, aseptic sterile fill/finish capabilities with full analytical services of micro, sterility, QC an­alytical and environmental monitoring, in­cluding method optimization.

The facility specializes in lyophiliza­tion. “Complex therapeutics, particularly biologics, require high standards and ex­treme care to match client and patient

standards,” says Aeliya Jafri, Senior Man­ager of Commercial Operations and Drug Product, Bora Pharmaceuticals. “By fully in­tegrating its advanced lyophilizer into the fill line, Bora reduces human contact with products during the manufacturing process to provide stringent quality control and im­prove product yield. As a result, lyophilized parenterals are stabilized for distribution, leading to increased success during the conversion to packaging.”

Lyophilization and parenteral manu­facturing is particularly important for the rare and orphan drug needs for pharma clients and patients. Given the niche cate­gory that these therapies fall under, the Baltimore facility has experience with global regulators, ensuring operations are compliant with Annex 1 requirements, in­cluding PUPSIT implementation, as re­quired for EU distribution.

With tech transfer capabilities for process and lyophilization, including cycle development, Bora continues to invest in its Baltimore facility. The site is expanding a commercial-scale lyophilization process that will offer parenteral manufacturing ca­pabilities. In addition, the facility is in­stalling its next phase of isolator technology, building off its Groninger Flex Pro 50 isolator filling line.

“For CDMOs and their clients, the most vital aspect of drug delivery is strong, collaborative partnerships,” says Ms. Jafri. “In order to optimize product formulation and PFS design, process development en­gineers and operational excellence teams collaborate with customers to strengthen drug effectiveness while streamlining end-to-end manufacturing.”

Recently, Bora’s expert team further refined its aseptic fill-finish process for a lyophilized product, launching a full engi­neering run to evaluate process parame­ters, she explains. The site installed high-speed cameras to analyze needle position­ing, fill speed, and dispense timing prior to lyophilization. “This process improved system efficiency and product yield,” she says.

Credence MedSystems: A Leaner Approach to Injection Systems

Autoinjectors have played an impor­tant role in the evolution of injectable drug delivery. Understanding the factors driving their implementation gives guidance to as­sess their future role, especially as the mass adoption of certain therapies creates intense pressure on the sustainability ini­tiatives taking root in the industry.

They were originally developed to meet a specific and urgent need: rapid self-administration of antidotes in military settings, allowing for urgent drug delivery under extreme stress. This transition into civilian healthcare began with the emer­gency treatment of anaphylaxis, and then evolved again for use for self-injection treatment for migraines and for autoim­mune diseases such as multiple sclerosis, where patients often experience dexterity issues. In these cases, ease of use was not just a convenience, but a necessity. Today, the landscape has changed again. In areas such as metabolic disease and GLP-1 therapies, many patients do not face the same urgency, physical limitations, or bar­riers to self-injection as they once did. This raises an important question: can we con­tinue to justify the widespread use of sin­gle-use autoinjectors in all therapy areas?

“The scale of the challenge is signifi­cant,” says Sian Eden, Commercial Direc­tor, Credence MedSystems. “Hundreds of millions of autoinjectors are produced an­nually, primarily designed as disposable single-use devices. As sustainability be­comes a central priority for the pharma­ceutical industry, this model warrants re-evaluation. If we revisit the original pur­pose of autoinjectors – providing safe, simple, and effective drug delivery – we can ask: is there a way to deliver these same user benefits with a fraction of the material?”

The Credence Companion® Safety Syringe System offers an alternative to what has become the status quo, she says. Designed to integrate needle safety directly into the syringe, it eliminates the need for bulky add-on mechanisms that increase material use, weight, and volume. At the same time, it delivers some of the features associated with autoinjectors: clear end-of-dose feedback with a ‘click,’ needlestick protection, visibility of the drug, and ease of use in home settings. Beyond the user experience, the sustainability and opera­tional efficiency advantages are substan­tial. Reduced material, lower weight and smaller device size translate into lower manufacturing impact, more efficient transport, and decreased packaging re­quirements. “These efficiencies are partic­ularly valuable in cold chain logistics, where space and weight directly influence cost and environmental footprint,” says Ms. Eden. “The result is not only a more sustainable solution, but also a lower total cost of ownership.”

For therapy areas that still benefit from assisted delivery, Companion en­ables reusable and manual injector plat­forms that leverage its inherent safety and usability features, providing an additional pathway that retains user-centric design while further reducing waste.

“While autoinjectors remain vital in certain contexts, their universal application is no longer to be presumed. By challeng­ing assumptions and embracing smarter design, the industry can benefit from ‘In­novation Without Change’ – preserving what patients need while significantly re­ducing environmental impact,” she says. “It’s no longer a question of whether we can afford to change. The questions are how and when.”

LATITUDE Pharmaceuticals: Integrated Model Moves from Formulation to Clinical Production

LATITUDE Pharmaceuticals operates as a formulation-focused CDMO with an emphasis on injectable/parenteral drug formulation. It provides end-to-end serv­ices spanning preformulation, formulation development, analytical testing, and GLP/GMP manufacturing of sterile injecta­bles for both preclinical and early clinical-stage programs. These include a range of parenteral formats such as intravenous, subcutaneous, and intramuscular injec­tion, as well as advanced systems, includ­ing lipid nanoparticles, liposomes, and nanoemulsions.

LATITUDE uses an integrated devel­opment-to-manufacturing model, which allows clients to move from formulation design to clinical trial material production under cGMP, accelerating timelines and reducing technical risk, explains Matthew Singer, PhD, Vice President, Business De­velopment, LATITUDE Pharmaceuticals. The company also offers proprietary drug delivery platforms (i.e. PG Depot, na­noemulsions, and ClearSol™ solubilization technology) that enhance parenteral drug performance.

“These services address critical unmet needs in the injectables/parenteral mar­ket,” he says. “Many drug candidates – especially biologics and poorly soluble small molecules – face challenges such as low solubility, instability, poor bioavailabil­ity, injection-site toxicity, and difficulty achieving controlled release. LATITUDE’s services and technologies help overcome these barriers by improving solubility, sta­bilizing formulations, enabling sustained or targeted delivery, and ensuring sterility and regulatory compliance.”

The most prevalent injectable drug products today are biologics, including RNA- and protein/peptide-based thera­pies. These are commonly delivered via syringe (prefilled or from a vial), autoinjec­tors, and increasingly wearable or on-body delivery systems. LATITUDE Pharmaceuticals supports these products through a range of specialized services and technologies, such as formulation de­velopment for complex injectables (e.g., high-concentration biologics), particle en­gineering, and deaggregation and stabi­lization strategies to improve shelf life and delivery performance. LATITUDE also pro­vides fill-finish support, analytical testing, and process development tailored to par­enteral dosage forms. On the technology side, LATITUDE leverages advanced deliv­ery systems such as long-acting injecta­bles, nanoparticle formulations, and solubility-enhancing platforms.

To address the growing filling and packaging of parenteral drugs, LATITUDE Pharmaceuticals is optimizing its existing footprint to increase productivity and flex­ibility rather than building new sites. This has included repurposing underutilized R&D areas into GMP-compliant manufac­turing space, such as the addition of two negative-pressure suites to support spe­cialized and higher-containment processes and an EMA-compliant cleanroom.

Dr. Singer says: “This strategy reflects LATITUDE’s deliberate choice to remain a small, agile CDMO. A lean structure al­lows LATITUDE to adapt quickly to its pharma and biotech clients’ rapidly changing priorities, scale projects effi­ciently, and provide more responsive, cus­tomized support.”

Lifecore Injectables CDMO: Pushing the Limits for Viscous Formulations

Sterile filtration can be challenging due to low throughput and potential con­centration changes stemming from solu­tion viscosity, retention, or adsorption. The inherent difficulty in filtration of relatively large molecular weight polymers or highly concentrated biologics combined with the complexity of filling of the viscous solutions may force developers to consider alterna­tive terminal sterilization methods, which can sometimes result in undesirable prod­uct attribute changes.

“Lifecore Injectables CDMO provides a unique service for the injectables market related to sterile filtration and aseptic fill­ing of viscous formulations (>50 cen­tipoise) to eliminate terminal sterilization,” says Sheida Jamalzadeh, PhD, Sr. Process Engineer, Lifecore.

Lifecore’s sterile filtration solution uses a proprietary designed, validated, high-pressure sterile filtration (HPSF) system that adheres to sterile filtration guidance. Dr. Jamalzadeh says: “This solution has  earned Lifecore recognition as a CDMO with a differentiated ability to handle com­plex, highly viscous formulations. The sys­tem has been validated in various applications up to 100,000 centipoise.”

Recent products with complicated for­mulations have caused Lifecore to de­velop, expand, and validate the range of the HPSF system. A customer approached with a project that required Lifecore to ex­pand the capabilities of the HPSF system for a solution of >200,000 centipoise. “We’re currently working on a complex formulation that incorporates large con­centrations of Lifecore’s hyaluronic acid (HA), driving the formulation’s viscosity to the range of >200,000 centipoise,” she says. “We’ve successfully developed a process to overcome filtration issues at this increased viscosity, and it is currently under validation. We’ve also overcome addi­tional product flow and holdup challenges with other specialized equipment.”

In addition, while HPSF has tradition­ally been used to address high-viscosity challenges, it has also proven effective for lower-viscosity formulations with specific chemistries and solution attributes that lead to filter clogging under conventional filtration processing conditions. “At lower operating pressures, the material exhibited gel formation upon contact with the filter, resulting in system clogging,” says Dr. Ja­malzadeh. “Implementation of the HPSF design effectively mitigated this issue.”

Lubrizol: Stabilizing Solubility of Injectable Drugs

Injectable and parenteral dosage forms play a key role in treating acute and chronic conditions, and are particularly prevalent in oncology. A 2022 Dupont re­view found that 27.5% of parenteral active pharmaceutical ingredients (APIs) were for oncological therapeutics. Yet, up to 90% of promising APIs in development have poor aqueous solubility – including many of those intended for parenteral delivery. Low solubility negatively impacts dissolution, absorption, and pharmacokinetics, in turn compromising bioavailability and increas­ing formulation complexity. Existing excip­ients or manufacturing techniques can struggle to resolve all of these challenges, increasing the risk that much-needed ther­apeutics fail to reach the market.

“Where drugs for parenteral dosage forms are concerned, the range of suitable approved excipients is limited,” says Matt Finkelhor, Commercial Manager, Global Novel Polymers, Lubrizol. “The formulation challenges and strict safety requirements associated with injectables have limited successful commercialization of novel ex­cipients over the last three decades. Yet, many existing excipients fail to improve solubility sufficiently for today’s challeng­ing “brick-dust” APIs, while some may cause unwanted side effects for patients.”

For many oncology drugs, the dosage regimen is determined not only by the tox­icity of the API but also by that of the ex­cipient. Lubrizol developed its novel Apisolex™ polymer excipient to stabilize and enhance the solubility of BCS Class II and IV APIs for injectable drug formula­tions, opening up access to new and im­proved parenteral drugs, says Mr. Finkelhor. This is especially relevant in on­cology, where intravenous delivery ensures higher bioavailability and lower patient variability compared to oral delivery. “In addition to improving solubility by 102- to 105-fold for APIs, Apisolex polymer sup­ports high drug loading of up to 40%,” he says. “Together, these characteristics en­able greater API delivery in a smaller dose volume, potentially reducing either treat­ment time or dosing frequency to align with the demand for more patient-centric therapeutic regimens.”

Apisolex polymer excipient is based on sarcosine, a non-toxic, non-immunogenic, biocompatible, and biodegradable amino acid. The solubilization mechanism is based on micelle formation. The excipi­ent may be used with standard processing techniques to streamline and speed up manufacturing processes. As a patented technology, it can be used to formulate new APIs and reformulate existing ones to enhance their therapeutic effect and de­liver improved patient outcomes, says Mr. Finkelhor.

Mitsubishi Gas Chemical Co.: Gas Barrier of Multi-Layer Plastic Vials Are 20x Better Than COP

MGC supplies multilayer plastic vials with high gas barrier that addresses the issue of container closure integrity (CCI) and pH shift for cell and gene therapy (CGT) products stored and transported in harsh conditions.

Traditional glass and plastic materials for syringes and vials are filled with prob­lems, says Tomohiro Suzuki, Associate General Manager, OXYCAPT Team Leader, MGC. “Glass suffers from a range of issues – such as high-breakability and poor PH stability – while plastic has an in­sufficient oxygen barrier and UV barrier,” he says. The US FDA and pharmaceutical companies have searched for solutions. Competitors have launched advanced material products, but their oxygen barri­ers and drug stability have been met with criticism.

This led to the creation of OXY­CAPT™, which features the benefits of glass and plastic in a three-tiered, multi­layer, material. OXYCAPT features a water vapor barrier and drug contact layer made from COP (Cyclo Olefin Polymer) and an oxygen and carbon dioxide barrier layer with a high gas barrier polymer. “With low extractables, low protein absorption, and low breakability, all components come to­gether to produce the best high gas barrier material on the market,” says Suzuki. “The OXYCAPT-P Vial has high oxygen and CO2 barrier property, which is about 20 times better than COP. Through UV ab­sorption, OXYCAPT protects drugs better than COP and Glass Type I by cutting off UV light below 300nm.”

Noxilizer: Providing a Preferred Option for Terminal Sterilization of PFS

Noxilizer is a commercial manufac­turer of NO2 sterilization, which is becom­ing the preferred choice for biologic combination products such as prefilled sy­ringes that cannot tolerate traditional ster­ilization methods, says Christopher Thatcher, President and CEO, Noxilizer.

When sterilizing syringes and autoin­jectors, high temperature can lead to de­naturation or degradation of biologics. Pressure changes can force the plunger to move, allowing microbes and sterilant to contaminate the drug product, known as ingress.

Mr. Thatcher says that NO2 provides many benefits over other sterilization methods, including an ultra-low tempera­ture process (10°C-30°C) that maintains drug integrity; minimal vacuum option to prevent stopper movement and contami­nation of the drug product; surface sterili­zation with low to no residuals to enable use of polymer syringes/car tridges/vials; short cycle times (6-12 hours including aeration time) to support supply chain ef­ficiency; flexible critical process parame­ters for custom cycles; and a system that is simple and safe to bring in house to re­duce manufacturing time and supply chain risk.

He points to a study that compared ethylene oxide (EO) gas, vaporized hydro­gen peroxide (VHP), and NO2 gas sterili­zation. “As with other studies, this study found that for the EO- or VHP-sterilized sy­ringes, the ingress of EO and hydrogen peroxide (H2O2) molecules were detected in the filled WFI,” he says.

Additionally, EO-adducted or oxidized HSA molecules were observed in the HSA-filled syringes. In contrast, the NO2-steril­ized syringes exhibited immeasurable ingress of NO2 and protein degradation was not detected in HSA-filled syringes.

“This is important for any company delivering biologics in a PFS,” he says. “We encourage companies who are at the early stage of developing a biologic prod­uct to be delivered in a prefilled syringe to identify a partner with a technology best suited to preserving product integrity in  PFS, and then to work with their partner from early design through expose and re­turn and feasibility studies to validation, regulatory filing, and ultimately commer­cialization. This can help minimize the sur­prises and support your project’s success.”

PCI: Seamless Support from Clinic to Commercialization

PCI is a CDMO providing integrated end-to-end sterile injectable drug and drug device development, manufacturing, combination product assembly, testing and advanced packaging solutions. PCI sup­ports most complex parenteral therapies, from small-scale orphan drugs to large-volume small molecule and biologics in vials, prefilled syringes, autoinjectors, pens, and on-body injectors.

“Our solutions support biopharma companies in optimizing dosing and pro­viding convenient, easy-to-use patient-centric therapies to patients,” says Dawn Manley, Director Global Technical Sales, PCI.

In the area of pharma development, PCI provides First-in-Human early-phase studies through to commercialization and beyond, providing scalable formulation, process, and analytical support. New Cen­ters of Excellence in Bedford, NH, and León, Spain, support high potent and non-potent small molecules and biologics across vials, syringes, and cartridges, with expertise in lyophilization, IND readiness, drug-device combinations, long-acting in­jectables, and ophthalmic development.

PCI’s sterile fill-finish capabilities span early clinical to global commercial supply, delivering aseptic manufacturing, lyophilization, and scalable vial, syringe, and cartridge filling across North America and Europe. “With Annex 1-compliant technologies, scientific expertise, together with co-located pharmaceutical develop­ment laboratories, PCI delivers flexible, modality-agnostic sterile development and commercialization solutions,” she says. “And, to meet the increased need for iso­lator-based syringe and cartridge filling, we are adding additional high-speed pre­filled syringe and cartridge capabilities in North America and Europe to support batch sizes up to 200,000 complemented by fully automated visual inspection sys­tems.”

Device agnostic final assembly and packaging of drug-device combinations includes prefilled syringes, needle safety devices, pens, autoinjectors, and on-body injectors, with automated assembly, func­tional testing to ISO standards, and scala­bility from clinical to high-speed commercial lines processing 3-300ppm.

Patient-centric secondary packaging, labeling and kitting, cold chain storage and distribution, and late-stage cus­tomization support worldwide launches and lifecycle management for injectable and combination products.

“Combined, these investments rein­force PCI’s status as an integrated CDMO for injectable solutions, providing seamless support from clinical trial supply through commercial launch, supported throughout by global capacity, technical expertise, and deep scientific knowledge,” says Ms. Manley.

SCHOTT Pharma: Supporting Glass & Polymer Platforms for Sensitive Biologics

Ready-to-use (RTU) primary packag­ing is becoming increasingly important across parenteral development and com­mercial supply, with prefilled syringes (PFS) leading adoption as an integrated drug containment and delivery solution. By sim­plifying preparation and reducing in-process handling, PFS solutions can improve operational efficiency in clinical settings and support smooth and stan­dardized workflows in fill-and-finish pro­cessing. These advantages translate into opportunities to reduce complexity and total cost across the product lifecycle. At the same time, PFS formats align with the continued shift toward self-injection and homecare applications, where usability and reliable performance are critical.

“In today’s market, vaccines and bio­logics remain key drivers of PFS demand, alongside chronic therapies that increas­ingly rely on device-assisted self-injection,” says Michelle Roos, Global Product Man­ager Polymer Solutions, SCHOTT Pharma.

For glass PFS, SCHOTT Pharma offers platforms such as syriQ® (for vaccines) and syriQ BioPure® (for sensitive biolog­ics). The syriQ BioPure platform is manu­factured from FIOLAX® Type I Borosilicate Glass and engineered to address biologic-specific risks such as drug container inter­actions while supporting consistent functionality and compatibility with autoin­jectors and safety systems.

For polymer PFS, SCHOTT Pharma’s SCHOTT TOPPAC® platform uses Cyclic Olefin Copolymer (COC) to enable robust handling, precise dimensions, and design flexibility for advanced IV connectivity and device integration. Injection molding en­ables stable, repeatable quality within tight specifications. Cross-linked siliconization is intended to support low particle levels and controlled silicone behavior, helping address the needs of sensitive biologics, explains Ms. Roos. The platform is also de­signed to maintain container closure in­tegrity during cold-chain handling and storage, and it is available in standardized nest-and-tub configurations that support efficient processing on established fill-and-finish lines.

Emerging advanced therapies – such as cell and gene therapies (CGTs) and an­tibody drug conjugates (ADCs) – are in­creasing the technical demands placed on primary containers and are accelerating the shift toward ready-to-use formats where appropriate. CGTs, in particular, often depend on tightly controlled cold-chain logistics at ultra-low or even cryo­genic temperatures, which elevates requirements for mechanical robustness and reliable container closure integrity under extreme conditions.

In parallel, ADCs’ complex and po­tent formulations can increase sensitivity to factors such as light exposure and drug container interactions, underscoring the need for packaging systems that protect stability and performance throughout the product lifecycle. Against this backdrop, SCHOTT Pharma supports development programs with complementary PFS plat­forms: glass syringes engineered for sen­sitive biologics (e.g., syriQ BioPure) and polymer PFS options designed for deep-cold storage and transport, where temper­ature resilience is a critical constraint, says Sven Pohle, Global Product Manager Glass Syringes, SCHOTT Pharma.

As injectable products and delivery systems become more integrated, success­ful PFS platforms increasingly depend on partnership across the full ecosystem: pharma companies, primary packaging and device suppliers, fill-and-finish equip­ment vendors, and CDMOs.

“SCHOTT Pharma actively builds strong, long-term collaborations to align container design, components, and processability early, thereby reducing downstream rework,” says Mr. Pohle. “For pharma companies, early involvement of key partners helps confirm drug stability with the right container choice while also establishing a supply chain and industrial­ization pathway that supports fast time-to- market and scalable capacity from clinical to commercial.”

Simtra BioPharma Solutions: Advancing Parenteral Manufacturing in a More Complex Injectable Landscape

The rapid growth of injectable thera­peutics – particularly biologics and highly potent molecules – is placing unprece­dented demands on parenteral manufac­turing and primary packaging systems. At Simtra BioPharma Solutions, the focus is on providing advanced sterile fill-finish and packaging services that help pharma­ceutical innovators safely and efficiently bring complex injectable products to mar­ket while maintaining quality and patient safety.

Monoclonal antibodies, long-acting injectables, antibody-drug conjugates (ADCs), and targeted therapies now rep­resent a significant portion of the develop­ment pipeline. These molecules often have challenging characteristics, including high viscosity, sensitivity to shear, and limited stability windows. “Simtra offers flexible manufacturing platforms capable of filling multiple container formats – including vials and prefilled syringes – across clinical and commercial scales,” says Greg Sacha, PhD, Global Senior Scientist, Simtra Bio­Pharma Solutions. “Our technologies are designed to deliver precise dosing, mini­mize product loss, and support stringent particulate and sterility requirements.”

Like many CDMOs serving the in­jectable market, Simtra is planning and executing significant capacity expansions to support sustained growth in parenteral drug manufacturing through the end of the decade. These investments include ad­ditional high-speed isolator sterile filling lines, expanded visual inspection capabil­ities, and enhanced secondary packaging operations. The goal is to provide cus­tomers with end-to-end services – from clinical supply through commercial launch – while maintaining flexibility to accommo­date evolving product requirements, says Sacha.

Strong partnerships are essential when addressing the technical challenges associated with advanced parenteral products. In one collaboration, a pharma­ceutical partner faced issues related to sy­ringe functionality and variability during administration. “By working closely across development, testing, and packaging teams, Simtra helped identify the root causes through performance testing and process optimization,” he says. “The result was a more robust PFS configuration that improved dose delivery consistency and improved the patient experience.”

Singota Solutions: Supporting the Evolving Complexity of the Parenteral Market

Singota Solutions provides integrated contract development and manufacturing services for sterile injectable drug prod­ucts, with a focus on bridging early-phase development through clinical and com­mercial supply. Within the parenteral mar­ket, Singota addresses a persistent gap between formulation development, fill/fin­ish readiness, and regulatory-compliant manufacturing, says Tim Wilson, Manager, Business Development & Marketing. “By combining formulation development, an­alytical support, aseptic processing, and cold-chain logistics under one operational framework, Singota reduces technology transfer friction and accelerates timelines for complex injectable programs,” he says. “This is particularly relevant for emerging modalities where traditional, linear devel­opment models introduce risk and delay.”

Today’s parenteral landscape is dom­inated by biologics, including monoclonal antibodies, peptides, and increasingly complex large molecules requiring precise handling and stability control. These prod­ucts demand robust formulation strategies, low-shear processing, and stringent par­ticulate and sterility assurance. Singota supports these needs through capabilities in preformulation, formulation optimiza­tion, aseptic fill/finish, and analytical char­acterization. In addition, Singota operates specialized environments for temperature-controlled storage and distribution, as well as transportation simulation studies to en­sure product integrity across the supply chain – an increasingly critical requirement for regulatory submissions.

Cell and gene therapies (CGTs) and antibody-drug conjugates (ADCs) are ma­terially reshaping the prefilled syringe (PFS) and broader parenteral market. These modalities introduce heightened sensitivity to shear stress, temperature excursions, and container-closure interactions. As a result, there is a growing need for cus­tomized fill strategies, low-volume preci­sion dosing, and enhanced compatibility studies between drug products and deliv­ery systems. For PFS in particular, chal­lenges around viscosity, aggregation, and extractables/leachables are more pro­nounced.

“Singota’s approach emphasizes early integration of formulation and con­tainer considerations, ensuring that device compatibility and manufacturability are addressed in parallel rather than sequen­tially,” says Mr. Wilson.

To meet increasing demand, Singota continues to invest in expanding its sterile manufacturing footprint, capabilities, and supporting infrastructure. These expan­sions are designed to support commercial readiness and operations, enhance aseptic fill/finish capacity, increase flexibility for small-batch and personalized medicines, and strengthen cold-chain and GMP stor­age capabilities. The goal is to enable Sin­gota to support a diverse pipeline, ranging from traditional biologics to next-genera­tion therapies.

A representative partnership high­lights this integrated model. A biotech client developing a temperature-sensitive biologic for clinical trials faced challenges related to formulation stability and ship­ping validation for regulatory submission. He explains that Singota collaborated closely with the client to optimize the for­mulation for improved stability under real-world conditions, while simultaneously executing transportation simulation studies to generate data supporting distribution robustness and product stability. The re­sulting dataset enabled a defensible regu­latory package aligned with expectations from agencies such as FDA and EMA.

“By aligning development, manufac­turing, and distribution considerations early, the program avoided delays and re­duced downstream risk,” says Mr. Wilson.

Terumo: Integrated Development Derisks Global Launch of a PFS

Sustained growth in biologics, com­plex injectables and combination products is continuing to place pressure on par­enteral filling, assembly, and packaging  capacity, while also increasing the techni­cal complexity of development and com­mercialization programs. In response, Terumo has further strengthened its inte­grated CDMO model to address these evolving requirements across the full life­cycle of parenteral drug products, from early development through to commercial supply.

“Rather than concentrating on individ­ual outsourced steps, this model brings to­gether formulation optimization or stabilizing, primary container selection and design, sterile fill and finish, device in­tegration and final packaging within a sin­gle, coordinated technical and quality framework,” says Michele Guasti, Global Product Manager, Terumo Europe.

This integrated approach supports earlier identification and mitigation of risks related to drug-container and drug-device interactions, enables more efficient tech­nology transfer between development and manufacturing stages, and facilitates smoother scale-up to commercial vol­umes. He says: “As regulatory expectations for combination products continue to in­crease, cross functional teams with expert­ise spanning drug product development, device engineering, process development and quality play a central role in ensuring alignment between technical design deci­sions and regulatory strategy, while also helping customers reduce supply chain complexity and timelines to market.”

A practical illustration of this ap­proach was provided during the develop­ment and global launch of a biosimilar antibody delivered via a prefilled syringe (PFS) combined with both a safety device and an autoinjector for self administration. The pharmaceutical company faced mul­tiple, interrelated challenges, including se­lection of an appropriate primary container, and ensuring reliable functional performance when the syringe was inte­grated with secondary delivery devices, Mr. Guasti explains. Terumo conducted com­prehensive compatibility and performance assessments in parallel to evaluate the be­haviors of the syringe when combined with commercially available safety devices and autoinjectors. These studies included analysis of critical functional parameters, such as break-loose and glide force, ro­bustness during handling and transport, and consistency of dose delivery across defined storage conditions and throughout shelf life.

Device assembly processes were de­veloped and validated under controlled conditions, with particular attention to process robustness, human factors consid­erations and the documentation require­ments associated with regulated combination products. “By coordinating formulation optimization or stabilizing, container selection, device compatibility testing, fill-finish activities, and assembly within a single development program, po­tential technical and regulatory issues could be identified and addressed earlier than would typically be possible had a fragmented outsourcing model been se­lected,” he says. “This integrated develop­ment strategy helped to de-risk the pharmaceutical company’s program and supported a successful multi-region launch across Europe, the United States and Japan, supplying both hospital-based and home-use settings.”

References

1. Prefilled Syringes Market to Reach US$193 Billion by 2033, Persistence Market Research Pvt Ltd., April 20, 2026, https://www.einnews.com/pr_news/906876742/prefilled-syringes-market-to-reach-us-19-3-billion-by-2033-expand­ing-at-9-8-cagr-persistence-market-research,
2. Dual Chamber Prefilled Syringes Market Size and Forecast – 2026 to 2033, Coherent Market Insights, March 27, 2026, https://www.coherentmarketinsights.com/industry-reports/dual-chamber-prefilled-syringes-market.