Dosage Form
Prefilled Syringe CDMOs
Compare CDMOs manufacturing prefilled syringe products for self-administered biologics and specialty injectables. Filter by syringe format, capacity, and combination product experience.
269 companies listed
About Prefilled Syringe Manufacturing
Prefilled syringes (PFS) are the fastest-growing injectable container format, driven by the shift toward self-administered biologics. PFS offer advantages over vials: reduced overfill waste, improved dose accuracy, simplified administration, and enhanced patient convenience. Manufacturing requires specialized equipment for syringe handling, filling, plunger insertion, and device assembly.
The combination product regulatory framework adds complexity. Prefilled syringes are regulated as drug-device combination products, requiring compliance with both pharmaceutical cGMP and device quality system regulations. CDMOs must manage extractables/leachables studies, container closure integrity testing, device functionality testing, and human factors studies for the delivery system.
Companies (269)
ABFEN FARMA
Turkey
ABFEN FARMA is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
AM Instruments
Italy
AM Instruments is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Frequently Asked Questions
What syringe formats are available?+
Standard PFS formats include: 1mL long (most common for biologics), 2.25mL (for higher-volume SC products), and 0.5mL (for vaccines). Glass barrels dominate, though polymer (COP/COC) syringes are gaining share for compatibility-sensitive products. Staked-needle and Luer-lock configurations serve different administration needs. Nested (tub) presentation is standard for isolator-based filling.
What additional testing is required for PFS combination products?+
Beyond standard drug product testing, PFS require: extractables and leachables studies (from syringe barrel, plunger, needle adhesive), container closure integrity testing (dye ingress, helium leak), functionality testing (break-loose and glide forces, needle penetration), particulate assessment (siliconized syringes can contribute sub-visible particles), and potentially human factors/usability studies if the PFS is intended for self-administration.
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