Capability
Pre-Filled Syringe CDMOs
Compare CDMOs with pre-filled syringe fill-finish capabilities. Filter by syringe format, batch capacity, and combination product experience.
104 companies listed
About Pre-Filled Syringe Manufacturing
Pre-filled syringe (PFS) manufacturing is a specialized fill-finish process for products administered by subcutaneous or intramuscular injection. The syringes arrive pre-sterilized in nest/tub format, are filled under aseptic conditions, and undergo plunger rod insertion, needle safety device assembly, and secondary packaging. PFS filling requires different equipment and expertise than standard vial filling.
Demand for PFS is driven by the shift toward self-administered biologics. Monoclonal antibodies for autoimmune diseases, GLP-1 agonists for diabetes/obesity, and other subcutaneous products increasingly use pre-filled syringes for patient convenience and dose accuracy. Global PFS demand is growing at 8-10% annually, making this one of the most capacity-constrained segments.
Companies (104)
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Stelis Biopharma
India
Stelis Biopharma is a leading, fully integrated biopharmaceutical CDMO based in India (Bangalore) with over 30 years of operational excellence. They brand themselves as 'OneSource' -- a multimodal specialty pharma CDMO with end-to-end capabilities across multiple tech platforms and therapeutic modalities. Their capabilities span biologics (microbial and mammalian cell culture, drug substance and drug product), complex sterile injectables (35 approved ANDAs and 19 commercialized drug products in the US), drug-device combinations (20+ automatic/semi-automatic assembly stations for prefilled syringes, pen injectors, autoinjectors), and soft gelatin capsules (2.4 billion per year capacity). They operate 5 state-of-the-art facilities approved by various regulatory bodies. Syngene acquired Stelis Biopharma's Unit 3 plant in Bangalore for biologics manufacturing.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
LubecaFill
Germany
LubecaFill is a German contract filling company offering sterile filling services for liquid dosage forms using Ready-to-Fill (RTF) technology. They provide filling into pre-sterilized vials, syringes, and cartridges, as well as contract filling of ampoules, oral and topical liquid dosage forms, and diagnostics/laboratory consumables. GMP certification is in preparation.
Frequently Asked Questions
What challenges are unique to pre-filled syringe filling?+
PFS-specific challenges include: syringe handling (nest/tub manipulation without particle generation), silicone oil management (barrier coating to prevent plunger sticking while minimizing sub-visible particles), tip cap integrity (maintaining sterility during storage), plunger insertion force control, and needle safety device assembly. For biologic products, silicone-oil-free syringes (cross-linked silicone or baked-on coatings) may be required to prevent protein aggregation.
What combination product requirements apply to pre-filled syringes?+
Pre-filled syringes are combination products under FDA regulations (21 CFR Part 4), requiring compliance with both drug cGMP and device quality system regulations (21 CFR Part 820). The CDMO must manage dual quality systems, conduct device-specific testing (container closure integrity, functionality, extractables/leachables), and support combination product regulatory submissions.
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