Production
Facts – State of the art technology
General
Semi-automated processes (PCS7) and automation development in-house
Upstream
Culture/Organism
Bacteria and Yeast Seed Fermentation:
10 L scale (stainless steel)
Main Fermentation:
1000 L scale (stainless steel) Cleanroom class: D
Downstream
Ultimate flexibility through established ball room concept Relevant downstream activities:
- Protein extraction and renaturation
- Ultra-/diafiltration
- Preparative Chromatography
- Pegylation
- Bulk filling of drug substance Cleanroom class: C
R&D/MSAT-Laboratory – Upstream/Downstream
- Verification and/or optimization of established processes
- Development of new processes (10 L scale)
- Support scale-up activities and transfer from pilot plant to industrial scale
Analytics
All up-& downstream activities are supported by our analytical development and quality control department:
- Method development (LC-DAD, LC- RI, HR-LC-MS/MS, GC-FID,GC-MS, ICP-OES, SDS-PAGE, immunoassays)
- GMP/GLP-compliant testing of raw materials, intermediates and final product
- Cleaning validation
- Microbiological analysis