BIBITEC GmbH & Co. KG
Your partner in biological drug development and production.
We are a Contract Manufacturing Organization (CMO) specialized in GMP-compliant protein production in mammalian cells. At BIBITEC we account for each client's individual needs for customized project support – from the initial idea to the finished product. BIBITEC is licensed to manufacture drug products up to clinical phase III.
As an 100 % subsidiary of Nordmark Pharma GmbH, we can offer a one-stop shop for your products. Together with our partners we can cover the entire value chain from process development to marketed drug products.
Bioprocess Development
Bioprocess Development
We develop and optimize cell culture and purification processes for our clients to produce their active substances efficiently – both for R&D and under GMP conditions.
GMP-Compliant API Production
GMP-Compliant API Production
At our site in Uetersen, we develop and optimize cell culture and purification processes and manufacture our clients’ active substances under GMP conditions in cleanroom environments.
Analysis and Quality Control
Analysis and Quality Control
At BIBITEC, we ensure GMP-compliant active substances through thorough analysis and quality control.
Regulatory Affairs
Regulatory Affairs
We prepare your regulatory documentation, support global registration processes, and provide consulting from early development through product registration.