Richter BioLogics

Richter BioLogics

Biotechnologieforschung

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

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Richter BioLogics is a world-class and expanding cGMP contract manufacturer (CDMO) of biopharmaceuticals, specialising in products derived from bacteria and yeast, based in Hamburg, Germany. We are recognised as a strong and experienced partner that offers one-stop solutions, including consultancy services. Over the past 35 years, Richter BioLogics has gained extensive experience in the development and manufacture of various product classes such as proteins, antibody-like scaffolds (VHH, Fab fragments, nanobodies), plasmid DNA (pDNA) using our proprietary pART process and vaccines. The company currently operates one development facility and two cGMP microbial production facilities. Richter BioLogics has now taken the next step in responding to the global demand for CDMO services by adding two more production lines of 300L and 1500L capacity to its Bovenau site. The development facility in Hamburg has also been expanded to provide capacity for new customer projects. Richter BioLogics is committed to meeting its customers' expectations and bringing their products to market in a timely manner. With flexibility, commitment to good manufacturing practice and total transparency, our experienced and motivated teams provide highly specialised contract development and manufacturing services to support the global pharmaceutical and biotechnology industries with process development and supply of products for clinical trials and commercial material. This is continually validated by the major regulatory authorities, including EMA, FDA, ANVISA, PMDA, Health Canada and MFDS, as well as numerous customer audits.

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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