Services

Full solution provider for mammalian cell culture

BIBITEC offers a full service for process development and GMP manufacturing of biopharmaceutical APIs for clinical trials up to phase III.

We are specialized in the production of:

Non-recombinant (native) proteins
Monoclonal antibodies (mAb)
Antibody fragments (Fab)
Other recombinant proteins (e. g. enzymes, hormones)

In cooperation with Nordmark Biotech, we can accompany your process from cell line development to market supply.

Cell Line

For our clients, we develop cell lines and create master and working cell banks – also under GMP conditions.

USP & DSP Development

For our clients, we conduct R&D and GMP-compliant manufacturing processes to ensure the highest quality and safety.

Formulation

We formulate active pharmaceutical ingredients (APIs) into the desired dosage forms for our clients.

Analytics

We perform comprehensive analytical testing for our clients to ensure the quality, purity, and safety of their products.

Clinical Trial Material

We manufacture Clinical Trial Material for our clients under GMP-compliant conditions for clinical studies.

Market Supply

For our clients, we work together with Nordmark to ensure reliable market supply of their products while complying with all regulatory and GMP standards.

Capacities

Our state-of-the-art production facilities allows for the following production capacities:

Lab scale (up to 2 L) – for development
Pilot scale (up to 200 L) – for clinical trials
Production scale (up to 2.000 L) – for continuous market supply