SPECIAL FEATURE - PFS & Parenteral Delivery: Innovation Is Focused on Patient-Centric, Smart & Sustainable Solutions

At the October PDA Universe of Pre-Filled Syringes and Injection Devices conference, two injection devices took center stage. The Innovation Award was presented to Crux Product Design and Pfizer for a 3D imaging and analysis of large- volume viscous injections with fast delivery rates in a porcine model. Their study takes steps toward providing high-resolution micro-CT visualizations with quantitative analysis of spatial injectate distributions and tissue responses (backpressure, bleb/wheal formation, leakage, intramuscular, and intradermal penetration) for different volume, viscosity, and rate combinations. For the first time, the interactions between injected formulation and tissue layers (including blood/lymph vessels) are shown in detail with 3D reconstructions and X-ray video for real-time visualization of fluid transport through SC tissues. The Partnership Innovation Award was presented to AstraZeneca and Team Consulting for a mechanical solution for reusable autoinjectors designed to realize cost and sustainability benefits.

Just this month, Halozyme Therapeutics, Inc. announced that argenx received FDA approval of VYVGART® Hytrulo prefilled syringe for self-injection to treat generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy. The 20- to 30-second single-dose subcutaneous injection was developed as part of argenx’s partnership with Halozyme’s ENHANZE® technology, which enables high-volume biologics delivery.

VYVGART followed ANI Pharmaceuticals, Inc. FDA approval of Purified Cortrophin® Gel in a prefilled syringe. This new presentation will be available in 40 USP units/0.5mL and 80 USP units/mL single-dose options through Cortrophin Gel’s established specialty pharmacy network. The prefilled syringe reduces administration steps for patients using Cortrophin Gel, which remains available in 5mL and 1mL vials.

This development and approval activity illustrates the expanding market for prefilled syringes (PFS), expected to reach $28 billion by 2032.¹ The market is driven by the prevalence of chronic disease, greater use of biologics and biosimilars, and the ever-growing trend of self-injection. These trends in PFS as well as advancements in autoinjectors and innovations in parenteral delivery are featured in this exclusive Drug Development & Delivery annual report.

Aenova: Additional Fill-Finish Capacity of 40 Million PFS/Vials Goes Live in 2026

As a leading global CDMO for the human and animal health pharmaceutical industry, Aenova has strong expertise in sterile manufacturing at its Latina site (Italy). Over the last two years, more than 30 million euros have been invested to offer customers modern, Annex 1-compli­ant, aseptic filling technology for sterile dosage forms, in particular vials and PFS. This new production is fully operational and a further fill-finish line with a capacity of 30 to 40 million PFS and vials will go live in 2026. Aenova is also currently investing along the entire process of man­ufacturing infrastructure, analytical capa­bilities, and cold chain warehouse, providing customers a comprehensive portfolio in the fill-finish area. The Latina technical team provides functional solu­tions and assures process reproducibility and reliability for accurate filling dosing and plunger position systems (with +/-1% accuracy), considered cutting edge for biologics autoinjector assembly, says Annalisa Barile, Vice President Operations, Aenova.

“As a result, Aenova will be able to offer its customers additional production capacity for PFS and vials using the isola­tor technology, enabling them to respond quickly to market demand, for example for diabetes medication,” she says. “Cus­tomers also benefit from differentiated technologies with development and large-scale manufacturing capabilities for small molecules and biologics. Additionally, Aenova has regulatory approval for many countries.”

Aenova offers a full range of tech­nologies to contain human intervention to provide proper Class A continuity and to ensure that product is protected from con­tamination. The current line, under oRABS, is suited for hydrogen peroxide sensitive products. The Ready-to-Use (RTU) technol­ogy also ensures the highest standards in terms of sterile assurance and foreign par­ticles reduction, she says. The line has 100% IPC for weight checks, ensuring a robust and reliable filling process and can run various formats, filling from 0.5mL to 10mL syringes or vials. “Thus, Aenova of­fers its customers the necessary flexibility in formats,” says Ms. Barile.

Cold chain capabilities with ultra-freezers for drug substance and extensive 2-8°C storage space complete the offering for a risk-free transportation process. An automatic visual inspection machine and manual or semiautomatic machines are qualified and run commercial products.

Aktiv: Patented Autoinjector Technology Accommodates Various Containers

Aktiv offers the PenPal autoinjector platform, which enables delivery of complex injections. PenPal is a gas-driven autoinjector platform with ultra-high per­formance reliability and capabilities to ac­commodate any standard glass syringe or cartridge up to 5.5mL. The device can de­liver high concentration drugs at a con­trolled injection rate. “This technology platform allows pharmaceutical partners to use different sized primary containers, and any needle gauge and length, without making any significant changes to the ac­tual autoinjector device,” says Amir Genosar, CEO of Aktiv.

Aktiv has demonstrated injections of over 100,000cP using PenPal’s high-pres­sure injection configuration. The patented technology applies pressure in equilibrium to both the primary container plunger and the external container walls simultaneously, thereby preventing high stress dur­ing the injection delivery. PenPal architec­ture consists of six molded components and four off-the-shelf components, pre­sented in two subassemblies for integra­tion with the filled primary drug container.

Aktiv CTO Greg Langley says that pa­tients benefit from the device performance reliability and unique human factors of the PenPal platform. “Audible, visual, and tac­tile feedback are presented to the user, and automatic needle retraction eliminates the current problematic practice that re­quires the user to count before manually removing the needle. The device also fea­tures an easy-to-inspect 360-degree in­spection window. Dose ranging becomes extremely simple with PenPal because the primary drug container can be filled to any desired level without making any changes to the device.”

Artcraft Health: Answering a Need with a No-Fail Training Device

“When it comes to patient-initiated in­jection delivery, you could do a lot worse than not training patients – you could train them ineffectively,” says Marty Mason, Sen­ior Director of Demonstration and Training Devices at Artcraft Health. According to Mason, this is a growing problem. Phar­maceutical companies and clinicians are becoming increasingly frustrated with au­toinjector training devices that do not last as long as expected or whose sounds and motions are inconsistent. As a result, pa­tients do not receive training that mirrors the use of a real commercial device, clini­cians lose faith with the brand, and com­plaint calls stack up.

The situation grows more complicated when you consider that patients are being trained on injecting themselves with a nee­dle – not an easy task even in the best of training circumstances. Artcraft Health Chief Creative Officer Stephanie Murrin says: “Many patients struggle with needle anxiety and self-injection, particularly those who are injection naïve. This can be a real barrier to treatment initiation and adher­ence. The right education that helps build skills, knowledge, and confidence is critical to get patients over that hurdle, so they have a positive experience and outcome.”

Artcraft Health, a full-service health education agency that partners with phar­maceutical, biotech, healthcare service, and medical device companies, recog­nized the need for a reliable training device that could help ensure successful patient onboarding. The result was demoX™an electronic autoinjector training device. DemoX is designed to replicate any com­mercial autoinjector, and it delivers five times as many demo cycles (at least 1,000) as traditional training devices, so clinicians can be better equipped to provide the training their patients need. Mason says: “With demoX, patients can be set on a path for more successful outcomes from the start.”

During the development of demoX, Artcraft Health focused on including fea­tures that would help make the device fool­proof for training. They also strove to match the commercial experience as closely as possible for a seamless transition from training to real use. Some of the fea­tures include a reset button, audible click sound, and plunger drop motion – all of which are identical to the commercial de­vice. DemoX also has a built-in demonstra­tion counter that provides an audio readout of the number of uses to date so clinicians can monitor how long the device lasts. It also includes an early lift-off notifi­cation that alerts the user when demoX has been lifted from the skin too early.

“In addition to developing a training device that serves an unmet need, it feels good to know that we can offer a sustain­able and cost-effective choice,” Mason says. “DemoX can reduce the number of trainers needed, contributing to reduced cost, waste, and carbon footprint.”

Bora Pharmaceuticals: Mitigating “Unknown Unknowns”

Bora Pharmaceuticals is a full-service global CDMO with a network of facilities specializing in the development and man­ufacturing of complex oral solid, liquid, and semi-solid dose forms, ophthalmics, biologics, and sterile injectable pharma­ceutical products for both clinical and commercial supply. At its Baltimore, MD, sterile fill-finish facility, Bora manu­factures and packages a portfolio of clini­cal and commercial sterile injectable products, including both small molecules and biologics. The site’s capabilities for vials, syringes, and cartridges are de­signed for flexible and scalable manufac­turing, supporting a variety of batch sizes, with approximately half of current products having a rare disease indication.

From PFS to autoinjectors to other for­mats, patient-centric drug delivery is con­tinuously evolving to better serve patients. “Bora stays at the forefront of patient-cen­tric solutions with its state-of-the-art Groninger FlexPro 50 isolator filling line, which features an integrated lyophilizer and capabilities for filling PFS, cartridges, and vials,” explains Tara Lorenz, Senior Director of Commercial Operations at Bora Pharmaceuticals. “Whether a client’s autoinjector uses a syringe or a cartridge as the primary container, Bora provides technology solutions that will ultimately benefit patients.”

For PFS, advances in plunger and needle design have resulted in enhanced product delivery, particularly for viscous products, while also reducing the risk of devices clogging. Key design elements that have improved the patient experience in­clude ergonomic features to reduce the force needed to inject with a device, safety features such as retractable needles and shielding mechanisms, and customization and flexibility options for delivery such as multi-dose variants or designs to sup­port delivery – from microdoses to larger volumes.

The next generation of PFS innovation will continue to improve the patient expe­rience with a focus on personalized medi­cine. “These designs may include the integration of smart technologies and AI, which will demand careful consideration of factors such as ensuring safety and reg­ulatory compliance, securing patient data, and designing user-friendly interfaces,” says Ms. Lorenz. “Real-time monitoring and predictive maintenance may well en­hance reliability, while seamless integra­tion with healthcare systems could improve data management. Balancing cost-effec­tiveness with benefits is crucial to the adoption of these features, however con­sideration of these elements would ensure smart injectable devices are safe, effective, and beneficial for healthcare providers and patients.”

Bora has extensive experience in tech transfer. Ms. Lorenz says a Bora client markets its PFS product in several config­urations, including as a prefilled autoinjec­tor and an on-body injector. Bora successfully supported the tech transfer and commercial launch of this product, building a trusted partnership along the way. She says this collaboration was driven by Bora’s technical expertise, transparency, responsiveness, and agility in mitigating “unknown unknowns.”

“The partnership with Bora was trans­formative for this client as with Bora’s sup­port it was able to meet an important milestone that ultimately enabled them to provide chemotherapy patients with im­mune support and enhance their quality of life,” she says.

Catalent Biologics: At the Intersection of Science, Engineering, & Digital Integration

Catalent Biologics provides compre­hensive CDMO services for injectable and parenteral products, leveraging more than 30 years of expertise in process develop­ment, formulation, and manufacturing. A state-of-the-art facility supports biologics, biosimilars, vaccines, and sterile injecta­bles from pre-clinical development through commercialization.

“We address critical market needs through our integrated approach to pre­filled syringe development and manufac­turing, with specialized capabilities in high-viscosity formulations, combination products, and device assembly,” explains Andrea Como, Vice President, General Manager, Core Biologics, Catalent. “Our isolator technology and flexible filling lines accommodate various container formats for vials, syringes, and cartridges while en­suring product integrity and sterility. By of­fering end-to-end capabilities from early development through small-scale com­mercial manufacturing, we help pharma­ceutical companies overcome the complex technical challenges of combination prod­ucts while accelerating time-to-market for life-changing therapies.”

Patient-centricity has fundamentally transformed PFS development. User test­ing across diverse populations, including patients, caregivers, and healthcare providers, has become essential to identify critical design requirements. This feedback drives innovations in ergonomics, intuitive operation, and safety features. Catalent begins every design process by addressing patients’ needs. Mr. Como says this ap­proach considers factors such as age de­mographics, dexterity limitations, cognitive abilities, and prior device experience.

“For instance, we’ve implemented larger pull tabs for patients with limited hand mobility and optimized packaging text for those with visual impairments,” he says. “Our recent investment in autoinjec­tor device assembly machines enables us to provide customers and their patients with solutions that not only ensure accu­rate medication administration but also enhance the overall treatment experience. Additionally, considering the entire patient journey has expanded our focus beyond the device itself to include packaging ac­cessibility, storage requirements, and dis­posal considerations.”

The future of PFS innovation lies at the intersection of formulation science, device engineering, and digital integration. “Catalent is positioned at this intersection, working to deliver the next generation of injectable solutions that prioritize patient needs while addressing the technical chal­lenges of increasingly complex biologic therapies,” says Mr. Como.

In fact, he is witnessing significant ad­vancements in addressing high-viscosity and high-concentration biologics, which have traditionally posed delivery chal­lenges. Novel syringe materials, optimized spring mechanisms, and advanced flow-rate controls are enabling comfortable de­livery of complex formulations.

Secondary packaging is also evolving beyond mere protection to become an in­tegral part of the user experience. Smart packaging with temperature monitoring, authentication features, and patient instructions is enhancing safety and com­pliance. Additionally, environmentally sustainable materials are becoming in­creasingly important as the industry ad­dresses its ecological footprint.

Looking ahead, connected devices represent the next frontier, he says. Autoin­jectors with digital capabilities will provide real-time injection data, medication re­minders, and integration with healthcare systems. “This connectivity will enable more personalized treatment regimens and improved adherence monitoring,” he says. “The most transformative innovations will likely come from collaborative devel­opment approaches that bring together expertise in formulation, device design, human factors, and manufacturing processes.”

Congruence Medical Solutions, LLC: Accurate & Precise Microliter Dosing with PFS

Congruence Medical Solutions, LLC is engaged in the design, development, and supply of drug delivery device solutions addressing unmet, emerging and hard-to-solve problems in microliter dosing, injec­tion of viscous/high-dose drugs, and minimizing drug waste at the point of in­jection. Recently, the US FDA cleared the company’s Microliter Dosing Syringe as an Ophthalmic Syringe with an indication for use in microliter volume injections into the eye (intravitreal).

According to Glenn Thorpe, Head – Sales, Business Strategy, Congruence Medical Solutions, LLC, this device was de­veloped to improve patient safety by en­abling accurate, precise microliter dosing, and by providing high quality drug contact materials. “The latter is addressed by using a prefillable syringe in a user-filled configuration, enabling access to advan­tages of prefillable syringes for applica­tions where prefilling is not feasible,” he says. “In the case of sensitive applications, such as injections into the eye, there is benefit from high quality materials of con­struction of prefillable syringes, including silicone-free.”

The Microliter Dosing Syringe is avail­able as a 510(k) cleared device in various models from 9 microliters to 100 micro­liters and has been shown to be accurate within 3 microliters with 95% confidence levels, Mr. Thorpe says. A number of human factors studies have shown high acceptance and preference (>80%).

He adds that because the device em­ploys a prefillable syringe, transition to a prefilled embodiment is seamless and can leverage the experience of non-prefilled embodiment. The device enables a stan­dard ISO-11040-compliant PFS to admin­ister precise microliter volumes.

“Given the significant overall risk in drug product development, we anticipate that more drug development programs in sensitive applications could employ prefill­able syringe to minimize the risk from un­known and unpredictable leachables from hypodermic syringes,” says Mr. Thorpe. “The device also preempts the need for dose markings on the syringe barrier be­cause dose metering is controlled by the device.”

Credence MedSystems: Advancing Intravitreal Drug Delivery

Intravitreal injections are a common treatment for retinal diseases such as age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion. As these conditions rise in prevalence and in­novator molecules come off patent, the pharmaceutical landscape is expanding to include not only innovative biologics and gene therapies, but also a growing num­ber of biosimilars that require intravitreal administration.

John Merhige, Chief Commercial Of­ficer, Credence MedSystems, Inc., says the Credence MedSystems Micro-Dose™ Sy­ringe System provides a critical solution to support the precise, safe, and sterile deliv­ery of these therapies – offering microliter-level accuracy, a clinician-centric design that supports proper use in clinical set­tings, and compatibility with terminal ster­ilization as well as secondary packaging to enable sterile-field use.

“Intravitreal dosing demands excep­tional precision,” he says. “Many oph­thalmic therapies, including biosimilars of anti-VEGF agents such as ranibizumab and aflibercept, are administered in small volumes where dose variability can impact efficacy or cause complications like ele­vated intraocular pressure. The Micro-Dose Syringe System is engineered to deliver consistently accurate microliter doses, ensuring that the drug products are administered within their narrow therapeu­tic window. This is particularly important as biosimilars enter the market and clinicians must maintain confidence in their consis­tent performance.”

Sterility is another critical factor in in­travitreal therapy. Infections such as en­dophthalmitis, though rare, can be devastating and are more likely when aseptic techniques or sterile integrity are compromised, says Mr. Merhige. The Micro-Dose Syringe System is compatible with terminal sterilization methods, ensur­ing that the drug-device combination ar­rives sterile and ready-to-use. Effective terminal sterilization, however, also de­pends on secondary packaging design. The Micro-Dose packaging must be specifically engineered to support sterilant penetration while preserving barrier in­tegrity and device performance.

“This design ensures reliable steriliza­tion without compromising ease of use or functionality – helping pharmaceutical companies meet regulatory requirements for combination products while streamlin­ing logistics and handling for healthcare providers,” he says. “This capability is vital, especially in outpatient and ambulatory surgical settings where these procedures are typically performed.”

Equally important is the clinician-cen­tric design of the Micro-Dose System, which promotes proper administration by enhancing clinician control and confi­dence. Its ergonomic form factor reduces user fatigue and time of injection while en­abling the precision required for ocular in­jections, explains Mr. Merhige. The system’s design facilitates the use of sili­cone-free and crosslinked silicone syringes that would otherwise present challenges associated with higher break loose and glide forces.

“If higher forces do present chal­lenges, Credence can employ its Force-As­sist™ technology to further improve control and comfort for clinicians during adminis­tration,” he explains. “Combined with its prefilled, ready-to-use format, the device minimizes preparation steps, reduces con­tamination risk, and improves workflow ef­ficiency in high-throughput retinal practices.”

The Credence Micro-Dose Syringe System meets the evolving needs of intrav­itreal drug delivery. As evidence, Credence is collaborating with a leading pharma­ceutical manufacturer for the deployment of Micro-Dose in an intravitreal dosing ap­plication. “With the global intravitreal in­jection market projected to exceed $10 bil­lion by 2028 (according to Grand View Research), driven by the increasing burden of retinal diseases and the rise of biosimi­lars and advanced therapies, this system offers a reliable, precise, and user-friendly solution that prioritizes safety, compliance, and patient care in retinal disease man­agement,” he says.

LATITUDE Pharmaceuticals: Integrated Approach Accelerates Timelines

LATITUDE Pharmaceuticals specializes in advanced drug delivery solutions, with a significant focus on injectables and par­enteral formulations. LATITUDE offers comprehensive services for the develop­ment of sterile products, including preclin­ical and clinical-stage parenteral formulations such as solutions, nanosus­pensions, nanoemulsions, liposomal for­mulations, and lipid nanoparticles. LATITUDE’s services span formulation de­velopment and analytical testing to clinical trial material (CTM) manufacturing under cGMP.

By offering flexible cGMP manufactur­ing capabilities with a focus on Phase 1 and Phase 2 CTM, LATITUDE is especially suited to meet the needs of emerging biotech companies and early-phase clini­cal programs. Matthew A. Singer, PhD, Vice President, Head of Business Develop­ment, LATITUDE Pharmaceuticals, says: “Our integrated approach accelerates de­velopment timelines and reduces technical risk, providing a seamless transition from formulation to first-in-human studies.”

LATITUDE addresses critical needs in the pharmaceutical industry by enabling the development of challenging injectable products, particularly those with poor sol­ubility and/or bioavailability, stability is­sues, or requiring targeted delivery. “LATITUDE’s expertise in solubilization, advanced formulation, and their applica­tion to injectables helps our clients over­come even the most difficult formulation barriers. LATITUDE supports a wide range of actives, including small molecules and biologics,” says Singer.

When providing secondary packag­ing for LATITUDE’s pharmaceutical drug product manufacturing, key considerations focus on tamper-evidence and preserving product integrity throughout the chain of custody. Tamper-proofing is critical to deter and detect unauthorized access. Features such as tamper-evident seals, shrink bands, breakable caps, and tamper-indi­cating adhesives are typically incorporated into LATITUDE’s secondary packaging. These components comply with regulatory guidelines (e.g., FDA 21 CFR, EU FMD) to ensure legal and safety standards are met.

To safeguard medicine integrity, pack­aging must provide protection against, and monitoring of, environmental factors such as temperature fluctuations, mois­ture, light, and oxygen. “The materials that LATITUDE uses are durable and provide a robust barrier to prevent contamination or degradation of the container,” he says. Se­rialization and track-and-trace technolo­gies like 2D barcodes or RFID tags can also be considered to ensure traceability and accuracy.

Lifecore Biomedical: An Injectables CDMO Ensuring Serialization & Safety

As an injectables CDMO, Lifecore Biomedical enables partners to comply with regulatory requirements for packag­ing, such as those set forth in the US Drug Supply Chain Security Act. “Our engineer­ing team has helped our partners imple­ment a variety of secondary packaging techniques such as tamper-evident seals on carton flaps that tear away the carton’s artwork when opened,” says Tony Bassette, manufacturing engineering supervisor, Lifecore Biomedical. “For quality control, we use sensors that measure and verify correct placement of the seals. Also, we heat-seal Tyvek pouches, creating a robust seal that is tamper evident.”

Another aspect of packaging protec­tion relates to serialization of products. For instance, one of Lifecore Biomedical’s partners had the CDMO serialize individ­ual cartons of commercial product. Those cartons are then packed into a six-pack that form a saleable unit, and those units are serialized as well, he explains. Next, four of the units are put into a case that is also serialized. All of the serial data is then aggregated for logistical tracing. This al­lows tracking of each individual carton to its placement on a specific pallet during shipping. Camera systems are utilized throughout the process to ensure that the printed serialization data is accurate and legible, he adds.

Lubrizol: Polymer Can Be Integral to Parenteral Development

Approximately 60% of potential active pharmaceutical ingredients (APIs) under development – and more than 40% of those in reformulation – are poorly water soluble, says Matt Finkelhor, Lubrizol Commercial Manager, Global Novel Poly­mers, Lubrizol. To address this challenge, Lubrizol’s Apisolex™ polymer, a GMP-val­idated, injectable-grade excipient, en­hances the solubility of BSC Class II and IV APIs by up to 50,000-fold. This polyamino acid-based polymer offers a non-toxic, non-immunogenic, biocompatible, and biodegradable alternative to other solubi­lizers while allowing for higher drug load­ing, he says.

“Low solubility drugs present signifi­cant challenges in pharmaceutical devel­opment, often leading to limited bioavailability and efficacy,” says Mr. Finkelhor. “This can restrict treatment op­tions and hinder the development of po­tentially valuable therapeutics. Apisolex polymer enables formulation of low solu­bility drugs, for intravenous or subcuta­neous administration, expanding the range of viable drug candidates.”

Apisolex polymer technology can be an integral solution for parenteral drug development projects where traditional ex­cipients or other formulation techniques have failed or where a patent-protected technology is desired, he explains. Apisolex allows for the development of APIs that were previously unable to progress, while avoiding the adverse ef­fects associated with other solubilizers. In addition, Apisolex polymer offers the po­tential to deliver some APIs by the subcu­taneous route due to higher solubilization properties.

“The polymer is a versatile, efficient, and safe excipient technology employing a poly (amino acid) chemistry to overcome the challenges of existing solubilizers,” says Mr. Finkelhor.

Apisolex technology holds robust patent protection in the US and interna­tionally, which allows for applications with new chemical entities via IND/NDA and drug products entering the market via the FDA’s 505(b)(2) regulatory pathway.

Noxilizer: NO2 Proves to be a Viable Alternative to EO

Noxilizer offers nitrogen dioxide (NO2) sterilization for single-use products like prefilled syringes, autoinjectors, and other medical devices. 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/car­tridges/vials; and simple and safe to bring in house to reduce manufacturing time and supply chain risk, explains Maura O. Kahn, Senior Vice President, Commercial, Noxilizer.

Companies may access NO2 steriliza­tion by purchasing and installing sterilizers in their own facility or their CMO or utilize contract sterilization services. “NO2 is a leading alternative to ethylene oxide (EO),” she says.

Noxilizer has successfully participated in a three-way partnership with a global biotech company and a CMO. The drug product is filled by the biotech company and shipped to the CMO where assembly and packaging take place. The biotech company installed a Noxilizer sterilizer in the CMO.

“Now, the manufacturing time has decreased from six months to two months because assembly, packaging, steriliza­tion, and final packaging happen in one location,” Ms. Kahn describes. Addi­tionally, the drug product is only shipped once during the manufacturing process versus three times when using contract sterilization.

“While all partnerships take effort, we have set up standard weekly and monthly calls/meetings,” she adds. “Each quarter, we meet in person. The result is that we are keeping communications flowing among the three companies. The product is now on the market and patients and physicians have access to another choice in their treatment.”

Noxilizer has several other customers awaiting regulatory approvals at the FDA and EMA.

PCI: Scalable PFS Solutions Speed Clinical to Commercial Transition

PCI is a CDMO that provides inte­grated end-to-end sterile injectable drug development, manufacturing, combination product assembly, and advanced packag­ing solutions to increase product speed to market. The company has launched more than 90 products each year over five decades of service. Spanning the cycle from development to commercialization, PCI offers injectable drug delivery solutions for large- and small-molecule therapies. Integrated sterile drug manufacturing, in­jectable assembly, testing, and packaging solutions optimize dosing for patients.

“Patient-centric solutions are pro­foundly reshaping the design and use of prefilled syringes in the pharmaceutical in­dustry,” says Bill Welch, Executive Director Market Development at PCI. “As therapies become more specialized and the focus shifts toward enhancing the patient expe­rience, prefilled syringes are increasingly prioritizing usability, safety, and conven­ience.”

For patients managing chronic condi­tions who require frequent injections, pa­tient-centricity is critical and emphasizes ease of use, particularly for self-adminis­tration. He says that modern PFS designs now feature ergonomic grips, clearer la­beling, and intuitive handling features, en­abling patients and caregivers to administer treatments safely and confi­dently, outside clinical settings.

When it comes to sterile fill-finish, final assembly, testing, and packaging re­quire rigorous attention to quality, preci­sion, and regulatory compliance. CDMOs like PCI Pharma Services are investing in scalable final assembly and packaging technologies to ensure consistent, high-quality PFS production, including ad­vanced aseptic prefilled syringe fill-finish capabilities and device testing systems.

PCI takes a collaborative approach when partnering with biopharma compa­nies to ensure the success of their prefilled syringe programs. From engaging early during the sterile drug product develop­ment/manufacturing stage, facilitating proactive clinical discussions and guidance on device strategy, qualification and selection through to actual PFS introduc­tion during clinical trials packaging de­sign, scale-up, regulatory readiness, and commercial launch.

“Every stage of development is driven by a shared commitment to the patient,” says Mr. Welch. “We work closely with our partners to align drug delivery, aseptic fill­ing, container closure selection, device functionality, human factors, labeling, test­ing, and packaging into a cohesive ecosystem – one designed to optimize us­ability, safety, and ultimately, therapeutic success. Device agnostic scalable tech­nologies, complemented with an estab­lished range of PCI-owned tooling, allows our client partners to progress through clinical trials to commercialization with re­duced investment and within an acceler­ated timeframe.”

SCHOTT Pharma: Advances in Large-Volume Subcutaneous Drug Delivery

SCHOTT Pharma is a drug contain­ment and delivery system provider with a portfolio of prefillable polymer and glass syringes, cartridges, vials, and ampoules. SCHOTT Pharma has addressed the grow­ing need for large-volume prefillable sy­ringes and devices for subcutaneous (SC) drug delivery with its new syriQ BioPure® 5.5mL glass PFS that can be used in an autoinjector, and the SCHOTT TOPPAC® infuse polymer syringes with a filling vol­ume of up to 50mL for use with the KORU™ Near Body Device infusion sys­tem.

“Patient-centricity continues to be cru­cial,” says Dr. Sven Pohle, Global Product Manager Glass Syringes at SCHOTT Pharma. “Both patient and user experi­ence are improved through a shift from in-hospital, intravenous administration to SC administration in a homecare setting and by new SC drug formulations that allow reduced injection frequency. The develop­ments of large-volume, high-dose SC medications and of large-volume contain­ers and devices, such as autoinjectors and pumps, support this patient-centric trend. For this purpose, the syriQ BioPure 5.5mL glass PFS has been developed as a co-de­sign with the YpsoMate® (Ypsomed) 5.5 autoinjector, with careful consideration of how to optimize patient comfort and ease of use of the system.”

For SC formulations larger than 5.5mL, polymeric PFS and infusion pumps can be used for at-home administration. “SCHOTT TOPPAC infuse 10, 20, and 50mL PFS are designed for use in the KORU infusion system, which is a reusable pump with a broad volume range and a patient-centric design,” says Christoph Za­uner, Head of Product Management Poly­mer Solutions at SCHOTT Pharma.

Tamper-evidence is an important fac­tor for protecting patient safety in PFS packaging. SCHOTT Pharma’s latest PFS innovation is the next-generation of SCHOTT TOPPAC infuse PFS that utilizes a tamper-evident cap-and-label system de­veloped in collaboration with SCHOTT Pharma’s Alliance to Zero partners. The Alliance aims to reduce carbon footprint with sustainable packaging solutions that ensure product and patient safety.

Several features of the new system im­prove safety and reduce medicine and packaging waste. The Cyclic Olefin Copolymer (COC) material used in SCHOTT TOPPAC syringe barrels is break-resistant and offers longer shelf life through increased stability compared to PP, says Mr. Zauner. A new, functional label can provide oxygen and light protection, and it covers the syringe shoulder com­pletely to provide a first-opening indication for each syringe, which reduces the possi­bility that usable medicine will be dis­carded. An RFID chip can be integrated into the label to enable automated inven­tory and digital first-opening indication. The new system uses an optional card­board box as a secondary package in place of the traditional plastic blister pack­age. The box protects the PFS against me­chanical impact and dust, yet it is easier for users to open and to recycle. It also saves space during transport, which can reduce carbon footprint.

“Through collaboration, SCHOTT Pharma has created a packaging system that meets the needs of their customers, health­care providers, and patients, while also im­proving sustainability,” says Mr. Zauner.

Simtra BioPharma Solutions: Patient-Centric Innovation

Prefilled syringes are becoming the preferred method of delivery for patients and providers alike due to the expansion of injectable therapies, especially biologics and specialty pharmaceuticals. Their con­venience, safety, and dose accuracy make them ideal for at-home administration. This shift comes with a heightened focus on patient-centric design that demands new levels of collaboration between phar­maceutical companies and contract devel­opment and manufacturing organizations (CDMOs).

“PFS are often used directly by pa­tients, many of whom may have limited dexterity or impaired vision – such as eld­erly populations,” says Greg Sacha, PhD, Global Senior Scientist, Simtra BioPharma Solutions. “Features like large print grada­tions and ergonomic plungers are no longer optional; they are critical for ensur­ing adherence and confidence during ad­ministration. Usability studies and human factors engineering must be integrated early in the development process to reduce the potential for error and discomfort.”

In addition, performance must be val­idated through rigorous testing. During development, PFS undergo extensive sta­bility studies to ensure integrity over the product’s shelf life. Among these, break force and glide force testing are crucial. These tests evaluate the force required to initiate and maintain plunger movement within the syringe. “If the force is too high, patients may hesitate or be unable to com­plete administration,” he says. “In some cases, “chattering” – when the plunger moves unevenly – can disrupt dose deliv­ery and cause patient anxiety. Addressing these challenges early on reduces the risk of compliance issues later.”

Secondary packaging also plays a pivotal role in both user experience and safety. Individually sealed blister packs help guard against tampering and make it easy to identify compromised doses. This approach also aligns with healthcare provider needs, facilitating automated medication dispensing in hospitals and nursing units. Dr. Sacha says: “As packag­ing technology advances, incorporating smart features – such as time-temperature indicators or tamper-evidence tech — will likely become more prevalent, supporting better monitoring and traceability through­out the supply chain.”

Looking ahead, innovation is focused on minimizing residual volumes within the syringe after injection. Especially in high-cost biologics, even small losses can lead to significant waste. Future designs may optimize plunger mechanics or barrel coatings to ensure a more complete dose is delivered, maximizing efficiency and re­ducing overall drug fill volumes.

Partnerships between pharma innova­tors and CDMOs are central to bringing these complex products to market. Suc­cessful collaborations integrate packaging and device development from day one, he says. For example, many innovator com­panies have specialized teams dedicated to both primary and secondary packaging. Their insights into patient use cases and protection requirements ensure the final product meets regulatory and manufactur­ing standards and improves the patient ex­perience.

“CDMOs with expertise in human-centered design, robust testing protocols and flexible manufacturing platforms will be best positioned to meet the needs of both drug developers and the patients they serve as the demand for self-administered injectables grows,” he says.

Stevanato Group: Cutting Injection Time in Half

Ready-to-Use (RTU) containers, in­cluding syringes, vials, and cartridges are the DNA of Stevanato Group. Focusing on the parenteral market, the company sup­plies containers, drug delivery systems, and assembly and testing equipment – all supported by analytical and device testing services. Biologics, especially highly concentrated formulations enabling dose frequency reduction, require optimal con­tainer/device compatibility and minimal interaction between drug and materials used, potentially leading to protein aggre­gation, inorganic extractables, underdos­ing, and delamination.

In response, Stevanato Group devel­oped the Alba® prefillable syringe plat­form, which features a new cross-linked coating and involves a plasma treatment designed to minimize interaction between the drug and its container. “One standout feature of Alba syringes is their ultra-low sub-visible particle content, enhancing compatibility with biologic drugs and en­suring patient safety,” says Daniel Mar­tinez, Head of Product Management DCS & Analytical Services, Stevanato Group. Alba syringes can be supplied with a spe­cial Thin Wall (sTW) needle with an in­creased internal diameter. This innovation lowers the extrusion force and reduces in­jection time by nearly 50%, he says.

Cutting injection time was the goal of one customer. This leading pharmaceuti­cal company reported out-of-specification injection times with a PFS intended to be used in an autoinjector for its high-con­centration monoclonal antibody (mAb) product. A study conducted by the Technol­ogy Excellence Center (TEC) team revealed an issue with the silicone coating. The sprayed-on silicone leached out when in contact with the drug. As an alternative, the cross-linked silicone coating used in Alba syringes was proposed, significantly reducing the migration of silicone and providing a more stable and predictable gliding force. The customer’s main concern of injection time was successfully met, says Mr. Martinez. In addition, the interactions between the drug and container compo­nents were assessed using both, drug product and a placebo. “This underlines the importance of early collaboration be­tween pharmaceutical companies and the container supplier, able to provide strong, data-driven analytical capabilities and support,” he says.

Prefillable syringes offered by Ste­vanato Group are engineered with several key features to ensure they work seam­lessly with autoinjectors, enhancing the overall injection experience for patients. Tighter tolerances and a controlled dis­tance between the needle tip and the sy­ringe shoulder ensure a consistent injection depth, he explains.

“The designed-in high mechanical re­sistance, including features such as small round flanges and the avoidance of glass-to-glass or metal-to-glass contact, doubles the glass’s resistance, resulting in less breakage during handling and adminis­tration,” says Mr. Martinez. “Another criti­cal factor is a consistent break-loose and extrusion force profile throughout the en­tire product’s shelf life. These features en­sure a reliable patient experience, support timely launches, and minimize total cost of ownership.”

In addition to technological advances, one of Stevanato Group’s next innovations has introduced new sustainability practices focusing on alternative materials and processes enabling more sustainable sterilization techniques while maintaining the overall performance. For example, Stevanato Group communicates regularly with customers on a sustainable version of secondary packaging focused on biopoly­mers and recycled plastic. A bio-circular version of polystyrene and polypropylene that is used to produce secondary packag­ing of syringes has been identified, he says.

West Pharmaceutical Services: Innovations in Safety, Usability & Technology

West Pharmaceutical Services pro­vides primary containment systems and services, enabling pharmaceutical and biopharma companies with a wide range of choices to take their drug through the clinical phases and into the market in vial containment, or in a drug delivery or wearable device that encapsulates a pre­filled syringe or cartridge. From a services standpoint, West works with customers that have a platform or custom device, sup­porting them through design, industrializa­tion, manufacturing, assembly, labeling, and packaging across a network of global facilities. Typically, West works with cus­tomers to procure, qualify, and validate equipment for commercial volumes, but West also has the ability for small-batch clinical volumes to enable expeditious turnaround times for the purposes of de­sign verification testing, human factor studies, and other device services.

“By providing these types of integrated services, we can share our ex­pertise, knowledge and capabilities – es­pecially in the case of emerging pharma/biopharma companies – and therefore derisk the drug delivery device pathway to patient,” says Madhu Raghu­nathan, Senior Director, Technical Services Business Development and Market Strat­egy, West Pharmaceutical Services.

He says that several innovations may advance the current state of drug contain­ment and delivery. First, there is a greater demand for reusability (multiple use) and sustainability, as well the removal of preservatives such as Benzoates, Sorbates, and Propionates that are added to the drug during the formulation phase. “Re­moval of preservatives while ensuring sterility across multiple administration seems at odds with each other, but novel technological solutions can help address this dichotomy,” says Mr. Raghunathan.

Second, technological solutions such as pneumatically powered injection mechanism that support the self-administration of highly viscous bi­ological drugs could become mainstream, as could adoption of smart tags/labels for improved tracking and traceability and safety. He explains that tamper-proofing and safeguarding drug product integrity comes in different varieties. For example, seals – considered to be secondary closure components – perform critical functions such as maintaining pri­mary packaging integrity by firmly holding the stop­per in place, protecting the injection site on the stopper, and providing evidence of tampering.

“Specialized folding box designs, novel closures such as West’s manufactured Daikyo PLASCAP® RUV closure, use of integrated near-field-communication tags, are also increasingly used to ensure tamper-proofing of injectable drugs,” he says.

Innovations in autoinjectors and safety devices are supporting the acceleration of drug delivery from a hospital and clinic setting to home environ­ment wherein the drug is delivered in a PFS format. Mr. Raghunathan says: “Technological advance­ments such as enhanced digital monitoring, im­proved usability and safety features for easier drug administration paired with comprehensive testing and human factors studies, are making it simpler for patients to self-administer drugs.”

Reference

1. https://www.globenewswire.com/news-release/2025/04/10/3059600/0/en/Global-Prefilled-Syringes-Market-to-Cross-USD-28-Billion-by-2032-DelveInsight.html