Richter-Helm BioLogics

Richter-Helm BioLogics

Biotechnologieforschung

GMP-compliant microbial production of biopharmaceuticals - Flexibility makes the difference

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Richter-Helm BioLogics is a best in class and expanding Hamburg, Germany-based cGMP compliant contract manufacturer (CDMO) of biopharmaceuticals specialized in products derived from bacteria and yeasts. We are recognized as a partner offering solutions from one source including consultancy services. Over the past 35 years Richter-Helm gained substantial experience in the development and manufacture of different product classes e.g. recombinant proteins, antibody-like scaffolds (VHH, Fab-fragments, Nanobodies), pDNA via our proprietary process RHB-pART, and vaccines. The company currently operates a development facility and two cGMP manufacturing facilities for microbial production. Now Richter-Helm takes the next step reacting to the global demand for CDMO services adding two further production lines of 300L and 1500L volume to its Bovenau production site. Also the development facility in Hamburg has been enlarged to offer capacities for new client projects. The expansion will triple biopharmaceutical production capacity and strengthen Richter-Helm´s position to fulfill customers’ expectations even more. With flexibility, commitment to good manufacturing practice and total transparency our seasoned and motivated teams offer highly specialized contract development and manufacturing services to support the global pharmaceutical and biotechnological industries with process development and supply of products for clinical trials and commercial material. This is constantly verified by major regulatory bodies including but not limited to EMA, FDA, ANVISA, PMDA, Health Canada and MFDS as well as by numerous customer audits.

Website
https://www.richter-helm.eu
Branche
Biotechnologieforschung
Größe
201–500 Beschäftigte
Hauptsitz
Hamburg
Art
Kapitalgesellschaft (AG, GmbH, UG etc.)
Gegründet
1987
Spezialgebiete
Microbial-derived biopharmaceuticals, Strain development, Establishment of cell banks, Process development, Development and validation of analytical methods, including biological assays, Supply of products for clinic phase I - III, Commercial GMP manufacturing, In-house QC testing and release , Stability studies according to ICH - guidelines, Process Validation, PPQ, VHH/Nanobody production, pDNA production, RHB-pART process und protein production

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