Richter BioLogics

Overview

Richter BioLogics is a leading, Germany-based Contract Development and Manufacturing Organization (CDMO) with over 35 years of experience in microbial-derived biopharmaceuticals. The company operates a development facility and two cGMP-compliant manufacturing facilities specializing in bacterial and yeast-derived products.

Capabilities

Product Classes:

• Recombinant proteins and peptides
• Antibodies (VHH/Nanobodies, Fab fragments)
• Plasmid DNA (pDNA)
• Bacterial vaccines

Process Development Services:

• Strain and fermentation development (E. coli and Pichia production technology)
• Downstream process development
• Process characterization

Manufacturing & Scale-Up:

• GMP drug substance manufacturing
• Bioreactor capacities up to 1,500 litres for microbial fermentation
• Phase I to Phase III and commercial supply capability
• Recent expansion with two additional bioreactors (300L and 1,500L)

Analytics & Quality:

• GMP and development analytical services
• Comprehensive QC testing meeting client and regulatory requirements
• Quality system compliant with cGMP standards of leading regulatory bodies

Regulatory & Quality

Richter BioLogics has been verified by major regulatory authorities including EMA, FDA, ANVISA, PMDA, and MFDS. The company achieved zero findings in its most recent FDA inspection, reflecting operational discipline in batch records, systems, and quality decisions. The organization emphasizes audit readiness as standard practice and maintains consistency in quality management across all operations.