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Contract manufacturing monoclonal antibodies
SIFIN GmbH Berlin offers contract manufacturing of monoclonal
antibodies based on your cell line. Benefit from our many years of experience in contract manufacturing of monoclonal antibodies.
SIFIN's effective quality management system enables us to handle all in vitro diagnostic-relevant product groups and markets, including FDA-regulation product groups for the US market.
■ DIN EN ISO 9001
■ DIN EN ISO 13485
■ IVD directive 98/79/EC - list A products
■ FDA approved cGMP production site for monoclonal antibodies since 2004
■ Manufacturing permit for veterinary diagnostic monoclonal antibodies
You supply SIFIN with the cell line and SIFIN provides you with the monoclonal antibodies in quantities ranging from a few milligrams right up to kilograms:
■ Cell culture supernatant (high product concentrations)
■ Purified
■ Conjugated
SIFIN delivers in accordance with agreed specifications by
fixed deadlines, enabling tight coordination with your production
chain.
If you have questions about our range of services or you would like more detailed product specifications (purity tests, specificity tests, etc.) or to arrange process validations, then please contact our Head of Department Monoclonal Antibodies:
Alexander Nagel
Fon +49 30 / 92 70 30-0
Fax +49 30 / 92 70 30-30
E-mail a.nagel@sifin.de |