West Pharmaceutical Services Unveils “Synchrony S1” Syringe System to Speed Drug Packaging Development

West Pharmaceutical Services (NYSE:WST) outlined a new approach to prefillable syringe (PFS) packaging development during a webinar hosted by Pharmaceutical Online, framing the offering as a way to reduce development complexity and shorten timelines for drug developers—particularly emerging biotechnology companies preparing for clinical fill.

Packaging development pressures and the shift to combination products

Dr. Bettina Boltres, Director of Scientific Affairs, Integrated Systems at West, said development teams face increasing pressure from long development timelines, complex regulations, and supply chain challenges. She noted that bringing a medicinal product to market typically takes 10 to 15 years and can require investments of $1 billion to $2 billion. Boltres also said that effective market exclusivity is often reduced to seven to 12 years due to lengthy development and regulatory timelines.

She cited industry trends since 2016, saying the time from first patent to launch has shortened from 16 years to an average of 10.6 years for larger pharmaceutical companies. Boltres added that delays can be costly, stating that a single day of delay can result in losses of around $500,000 in sales in high-value therapeutic areas, while average daily revenues per product have declined by roughly $80,000 to $100,000 in recent years.

Boltres attributed some of the growing burden to syringes being regulated as combination products. She said syringes were historically treated more as container closure systems, where meeting pharmacopeial requirements was sufficient, but are now evaluated as both drug packaging and a device constituent part. That shift, she said, brings additional requirements across regions and agencies, including increased complexity in Europe due to the role of Notified Bodies.

She described the standards landscape as expanding from pharmacopeial requirements (including USP 381 for elastomer components and USP 660 for glass containers) to device-related ISO standards such as ISO 8871 for elastomers and ISO 11040-4 for glass syringes. Boltres also pointed to a growing focus on final-system performance standards, referencing USP 382, USP 1207, and ISO 11040-8, along with differences between USP 87 (elastomer-focused) and ISO 10993 (final-product biocompatibility).

Development teams’ current challenge: building systems from components

Boltres said many teams still assemble a PFS system by sourcing components from multiple suppliers, then testing combinations and compiling specifications and documentation for regulatory submissions. She emphasized that component specifications can be difficult to reconcile due to different formats and units across suppliers—for example, particles, silicone oil, endotoxins, and break-loose/glide force data may be presented differently depending on the component.

She also highlighted practical hurdles such as different lead times and minimum order quantities, and the need to assemble regulatory documentation from multiple PDFs and sources for inclusion in an eCTD submission.

In two audience polls conducted during the session, Boltres said:

• 50% of respondents selected “all three” (regulations, device development resources, and supply chain) as equally heavy pressures, and among those who chose one, time and resources for device development ranked highest.
• 92% of respondents said they recognized the described development struggle when sourcing and qualifying PFS components.

West’s integrated “Synchrony S1” prefillable syringe system

West presented its West Synchrony S1 PFS system as an integrated, verified syringe system supplied as a complete set—including a glass syringe barrel (fixed needle or Luer lock) and a matching plunger, with a needle shield tip or cap—provided from a single verified supplier. Boltres positioned the system as a way to address three stated challenges: designing a syringe system from components, navigating the regulatory process, and avoiding supply chain setbacks.

She said West designed the system “from scratch,” owns the development process, and has completed design verification (DV) testing. West also performs system-level release testing and ships components in aligned quantities on the same pallet, supported by one item number and matching minimum order quantities.

Data packages and system-level specifications

Boltres said West is providing four document packages intended to support customers from early evaluation through submission:

• Scouting Info Package (67 pages): system overview, master specification (including system-level specs), component chemical/physical data, compatibility overviews (needle safety devices, auto-injectors, fill-finish equipment), quality/regulatory information, packaging, shelf life, pallet quantities, drawings, and item numbers.
• Onboarding Package: purchasing and shipping information, SAP item decoder, quality agreements/audits information, and quality certificate details.
• Verification Data Package (80+ pages): DV approach and results, including tests such as needle shield pull-off force, needle pull-out force, needle penetration, flange breakage resistance, break-loose and gliding force, container closure integrity (CCI) tests, deliverable and residual volume, and characterization including biocompatibility and extractables.
• Regulatory Package (80 pages): content intended to be copied into an eCTD submission, including support for non-DMF regions such as Europe and MDR-related requirements.

Boltres said the packages are free, available based on development milestones, and maintained as controlled documents (peer-reviewed and revision-controlled).

She also described a system-level specification approach intended to reduce incoming inspection complexity, providing a single data point per attribute for the full system (including particles, silicone oil, endotoxin, and break-loose/glide), reported on one quality certificate along with component-level measurements.

Manufacturing, compatibility testing, and product scope

Boltres said the manufacturing and system release process centers on West’s plant in Waterford, Ireland, where representative parts are assembled and tested against system specifications before shipment. She said West has more than 200 validated systems for biologics and vaccine applications across multiple sizes and configurations, including 1 mL and 2.25 mL formats, staked needle and Luer lock options, various needle gauges and wall thicknesses, multiple flange styles, and plunger options including NovaPure, FluroTec, and unlaminated plungers.

West also described two “Signature” make-to-stock systems held in Ireland and available for order, with flex and standard quantities:

• 1 mL staked needle with rigid needle shield and 27G or 29G thin wall, 0.5-inch needle, small round flange; NovaPure or FluroTec plunger; 10×16 nest; flex MOQ 12,000 systems and standard 48,000 per order.
• 2.25 mL staked needle with rigid needle shield, 27G thin wall, small round flange; NovaPure or FluroTec plunger; 10×10 nest; flex MOQ 7,500 systems and standard 30,000 per order.

Boltres said the system comes in nest-and-tub configuration and is ETO sterilized. She added that West uses SCHOTT FIOLAX Type I glass compliant with USP 660, EP, and JP, and stated that barrel dimensions follow ISO 11040-4.

During Q&A, Boltres said West does not sell a needle safety device as part of the offering, but has performed compatibility testing with certain needle safety devices. She also said West has tested the system with two leading 1 mL auto-injector suppliers using water for injection (1.0 cP) and 15 cP viscosity, and has additional testing planned. She described work with four fill-finish line manufacturers, including testing de-bagging/de-lidding, in-process handling, feeder bowl sorting, and placement compatibility.

On extractables and leachables, Boltres said leachables testing is out of scope because it must be conducted with the drug product, but West has performed extractables testing included in the Verification Data Package. She also said the Verification Data Package includes transportation and shipping data.

Boltres said the system shelf life is currently two years, based on the component with the shortest shelf life and tied to the sterile claim; she noted this does not determine the drug product shelf life, which is supported by drug product stability studies after filling.

In response to questions on PFAS and sustainability, Boltres said the current system is intended as a “drop-in solution” for today’s market, while West is exploring sustainability considerations and PFAS-related alternatives in future developments.

About West Pharmaceutical Services (NYSE:WST)

West Pharmaceutical Services, Inc is a global developer and manufacturer of components, systems and services that enable the containment and delivery of injectable drugs. The company focuses on high-quality packaging and delivery solutions for the pharmaceutical and biotech industries, producing primary drug packaging components and specialized drug delivery devices used for vaccines, biologics and other injectable therapies. West is known for its elastomeric closures, seals and polymer components that maintain sterility and compatibility with sensitive drug formulations.

In addition to component manufacturing, West provides engineered delivery systems and support services across the product lifecycle.