Contract Manufacturing of Monoclonal Antibodies

SIFIN, which was founded in 1991, is a long-established in vitro diagnostics company whose roots can be traced back to the Königlich-Preussisches Schutzblattern-Impfinstitut (Royal Prussian Smallpox Vaccination Institute).

Ever since its founding, SIFIN has produced monoclonal antibodies for the continuously growing demand for its own product portfolio, OEM partners and above all, on a national and international level for in vitro diagnostics manufacturers. Over the years, contract manufacturing in respect to both the range of services and quality management has been tailored to client needs.

Today, starting from an established production cell line, SIFIN offers all necessary services to ensure a steady supply of raw material to the client, be it for laboratory needs (mg) or large-scale production (kg).

Range of services:

• Characterisation of hybridoma cell lines
• Recloning
• Establishment, storage and care of working cell banks
• Production of monoclonal antibodies – in the cell culture supernatant, purified or labeled
• Production of recombinant proteins
• Production of mammalian cell biomass

Certified quality management:

• DIN EN ISO 9001:2000
• DIN EN ISO 13485:2003
• Production of products of Annex II, List A in accordance with IVD Directive 98/79/EC
• FDA-registered manufacturing facilities for monoclonal antibodies (No. 9085844)