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Biopharmaceutical Development and GMP Manufacturing: Clinical to Commercial Supply

Kai Pohlmeyer

August 10, 2020

1 Min Read

17-7-richter-helm-image-300x179.pngRichter-Helm is a Hamburg, Germany–based contract manufacturing company with a proven 30-year track record and specialized in products derived from bacteria and yeasts. Count on us to flexibly provide a comprehensive range of services and customized solutions. Clients worldwide already have benefited from our commitment to good manufacturing practice (GMP) and total transparency. Our work focuses on recombinant proteins, plasmid DNA, antibody fragments, and vaccines.

Our seasoned, 240-strong team supports you with process development, supply of products for clinical trials, commercial production, in-house quality control (QC) testing, and QP release. We operate two GMP-compliant production plants with bioreactor capacities of up to 1,500 L.

Richter-Helm consistently works to the highest standards of pharmaceutical quality, as verified by major regulatory bodies, including the European Medicines Agency (EMA), the US Food and Drug Administration (US FDA), Agência Nacional de Vigilância Sanitária (ANVISA), and the Japanese Pharmaceuticals and Medical Devices Agency
(PMDA) and Ministry of Food and Drug Safety (MFDS), as well as by numerous customer audits.

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