Development and GMP Manufacturing of Biopharmaceuticals

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With Richter-Helm BioLogics and Richter-Helm BioTec, over 20 years of experience in development and manufacturing of biopharmaceuticals and the innovative strength of high-performance teams are coupled with the solid foundation of the owner companies Gedeon Richter Plc. (Hungary) and HELM AG (Germany).

Preclinical to Commercial Supply

Richter-Helm BioLogics offers services for development and manufacturing of biopharmaceutical products from customers in the pharmaceutical and biotechnology industries. Richter-Helm BioLogics develops and produces recombinant proteins, plasmid DNA, and vaccines in microbial systems. Richter-Helm BioTec is responsible for business development, marketing, and sales activities as well as the management of product developments — not only for their own pipeline, but also for joint project development work in collaboration with associate companies. To enlarge the product pipeline, Richter-Helm BioTec is actively seeking for further development projects at all stages. Richter-Helm BioTec can be considered to be the often missing link between biotech companies and the pharmaceutical industry. The worldwide presence allows the company to fully exploit the market potential of the products on a global basis.

Thanks to our years of experience with protein expression systems, plasmid DNA technologies, and GMP manufacturing, we are in a position to offer our customers and business partners a first-class cost efficient service from the development through to the production stage. Our development services comprise the establishment of production strains as well as the development of fermentation and downstream processes for manufacturing of recombinant proteins, plasmid DNA, and vaccines. In our state-of-the-art GMP production facilities, we set up cell banks (MCB and WCB) and produce biopharmaceuticals both for clinical trials and market supply.

Your contact address for all questions and enquiries concerning contract development and contract manufacturing services as well as licensing collaboration opportunities is Richter-Helm BioTec.

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 like the following:

  • Production of recombinant proteins: development of production strains (E. coli, yeast); optimization of expression in different systems; establishment of MCB/WCB; development of fermentation (10–1,500 L) and downstream processes; development of analytical methods including bioassay development; validation of analytical methods; GMP manufacturing for clinical phase 1 to 3; 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; establishment of MCB/WCB; development of the fermentation (10–1,000 l) and downstream process; development of analytical methods; GMP manufacturing for clinical phase 1 to 3; GMP commercial manufacturing; and in-house QC testing and release

  • Production of vaccines: long lasting experience in the development and manufacturing of microbial vaccines

  • Business development: in-and out-licensing; partnerships for co-development.

Richter-Helm BioTec is evaluating new development projects to enlarge their 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.

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