Development and GMP Manufacturing of Biopharmaceuticals

View PDF


Richter-Helm BioTec is a dynamic and expanding biotechnology company located in Hamburg, Germany. Being one of the first biopharmaceutical enterprises in Europe, Richter-Helm has more than 20 years of experience in the development and GMP-compliant production of recombinant proteins, plasmid DNA, and microbial vaccines. With more than 120 employees Richter-Helm offers customized state-of-the-art solutions for all steps in biopharmaceutical projects through contract development and manufacturing services in GMP facilities for microbial production (fermentation scale up to 1,500 L). Beside our strong expertise in Escherichia coli, Richter-Helm successfully produces proteins in yeast (e.g., Pichia pastoris). Thus Richter-Helm is the ideal partner for biopharmaceuticals development by offering material from preclinical and clinical trials to market supply at a large scale. In addition Richter-Helm is the platform of Gedeon-Richter and Helm AG for worldwide licensing options as well as partnerships for codevelopment and marketing of biopharmaceutical development projects.


 

Products and Services

The teams at Richter-Helm have excellent expertise in development and manufacturing of biopharmaceuticals. This knowledge, combined with highest quality standards according to current regulatory requirements, is a prerequisite for reliable and successful collaborations. Richter-Helm offers its customers a full range of biopharmaceutical services

Production of Recombinant Proteins

  • development of production strains (e.g., E. coli and Pichia)
  • optimization of expression in different systems
  • establishment of MCB/WCB, development of fermentation (10–1,500 L) and downstream processes
  • development and validation of analytical methods including bioassays
  • clinical phase 1–3 and commercial GMP manufacturing
  • process validation, in-house QC testing, and release, and stability studies according to ICH.

Production of Plasmid DNA

  • development of production strains and establishment of MCB/WCB
  • development of fermentation (10–1,500 L) and downstream processes
  • development of analytical methods
  • GMP manufacturing for clinical phase 1–3 and commercial manufacturing
  • in-house QC testing and release

Production of Vaccines: Richter-Helm has long-lasting experience in development and manufacturing of microbial vaccines.

Business Development: Richter-Helm offers in- and out-licensing as well as partnerships for codevelopment.

Richter-Helm BioTec is evaluating new development projects to enlarge its own development pipeline and is offering license opportunities for co-development and marketing of biopharmaceutical products.

About the Author

Author Details
Kai Pohlmeyer, PhD, is head of business development at Richter-Helm BioTec GmbH & Co. KG, Nordkanalstrasse 28, 20097 Hamburg, Germany; 49-40-2375-2430; k.pohlmeyer@richter-helm-biotec.eu; www.richter-helm.eu

Leave a Reply