White Paper

Lessons from the Pandemic: Building a Better Prefilled Syringe

What the COVID-19 pandemic taught the pharmaceutical industry about prefilled syringe design, supply chain resilience, and the critical role of elastomeric components.

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About this White Paper

The unprecedented scale of COVID-19 vaccine production exposed the pharmaceutical industry's dependence on robust, high-quality prefilled syringe components — and revealed gaps in supply chain resilience, material availability, and packaging performance. This report by Datwyler explores the four key challenges of bringing vaccines to market: acceptability, accessibility, affordability, and availability — and how these factors shape primary packaging decisions between vials and prefilled syringes.

From ultra-low temperature storage requirements for mRNA vaccines to the selection of the right elastomer compound for protein-based biologics, the paper walks through the technical and commercial considerations that drive prefilled syringe design. Datwyler's portfolio — including the FM257, FM457, and NeoFlex™ coated plunger platforms — is evaluated against real-world extractable studies and thermal performance data at -50°C, demonstrating container closure integrity across storage conditions.

The report also highlights Datwyler's global manufacturing harmonization, collaborative qualifications with syringe barrel manufacturers, and services including extractable reports, functional performance data, and ready-to-use components — all designed to reduce time to market and total cost of ownership for pharmaceutical and biotech companies.

Prefilled syringes offer significant advantages over vials for vaccines and self-administered biologics — reducing contamination risk, minimizing dosing error, and improving patient experience — making them the preferred primary packaging format for many high-value injectable applications.
Datwyler's FM457 compound and NeoFlex™ coated plunger platform demonstrated superior extractables profiles and maintained container closure integrity at ultra-low temperatures (-50°C), making them well-suited for next-generation mRNA and protein-based vaccines.
Datwyler's globally harmonized manufacturing footprint — with sites using identical raw materials, processes, and specifications across continents — was a critical enabler of rapid, large-scale vaccine component supply during the pandemic, supporting both risk mitigation and time-to-market objectives.

Lessons from the Pandemic: Building a Better Prefilled Syringe

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