Bibitec GmbH & Co. KG
Profile
BIBITEC GmbH & Co. KG in Bielefeld is a contract manufacturer of biological active substances. It produces proteins and antibodies using mammalian cells under GMP, up to Phase III.
Services
Evidenced: named on the company’s own website. Unclear: checked, nothing conclusive found.
| Service | Status | EvidenceQuote from the company’s website (German) |
|---|---|---|
| Biologics and ATMP Manufacturing |
Evidenced |
„BIBITEC ist ein Auftragsproduzent (CMO) für die GMP-gerechte Wirkstoffproduktion mit Hilfe von Säugerzellen.“ Source · 10 Nov 2026 ↗ |
Official credentials
Manufacturing authorisation
The competent authority of the federal state authorises the site to manufacture, test or import medicinal products (Section 13 of the German Medicinal Products Act, AMG). Without this authorisation it may not do so.
DE_NW_02_MIA_2024_0017
Bielefeld
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗GMP certificate
The authority has inspected the site and confirmed that it complies with Good Manufacturing Practice (GMP).
DE_NW_02_GMP_2024_0014
Bielefeld
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗Sites
Universitaetsstrasse 27
33615 Bielefeld
Almestrasse 4-8
33649 Bielefeld
Guetersloher Strasse 54
33649 Bielefeld