Bibitec - API Manufacture for Clinical Trials on Humans

Bibitec Gesellschaft für Prozessentwicklung mbH is a subsidiary of NewLab BioQuality AG, Germany. Bibitec is located at the University of Bielefeld and is specialized in the production of proteins derived from mammalian cells. A five-year ErythroPOietin (EPO) project has been recently completed. This project involved the process development as well as the GMP-compliant production of EPO for use in phase III clinical trials. The entire production and purification process was successfully transferred to a third party for large-scale production and market supply.

Our core competences include: mammalian cell culture techniques, upstream and downstream process development, cGMP-compliant production of protein APIs for use in clinical tests (phase I - III), and process optimization and validation studies.

CELL CULTIVATION

Our cell cultivation projects feature: process development and production, batch, fed-batch and perfusion, suspension or microcarriers, defined media and animal component-free conditions, cell culture clarification, cell culture media testing and optimization, and serum-free adaptation.

CULTIVATION SYSTEMS

• Up to 100L bioreactors (stirred tank)
• Up to 10L Wave® bioreactor
• Shaker incubator
• Cellferm-pro®1
• Biostat® B Triple1

PROTEIN PURIFICATION

• Process development and production
• Filtration methods
• Chromatography methods
• Viral safety methods
• HCP and DNA removal
• Process validation studies including
• Cycle numbers, breakthrough and load limits
• Qualification of chromatography media
• Scale-down studies for viral safety and process-related impurity removal

PURIFICATION SYSTEMS

• Our Bioprocess® systems are 3mm isocratic and 6mm gradient.
• ÄKTA® systems include purifier 10, purifier 100 and explorer 100.
• For crossflow filtration we have a filter area up to 6m².

QUALITY ASSURANCE

We hold GMP certification as well as manufacturing authorisation for APIs intended for clinical trials (phase I - III) in humans. We are in possession of validated systems with validation master plan. We also have equipment qualification, site master file, stability testing and qualified dedicated production sites (class D and C).

ANALYTICS

• Cell density and viability (CEDEX®)
• Media nutrients, metabolites, amino acids, vitamins (YSI®, RP-HPLC1)
• Protein quantity and quality (RP-HPLC1, SDS-PAGE, Western blotting, ELISA)
• Glycostructure (HPAEC-PAD1, capillary electrophoresis1, IEF)
• Mass spectrometry (MALDI-TOF1, Quadrupole1)
• Several additional methods including lot-release testing

1In cooperation with the University of Bielefeld.