Biopharmaceutical Development and GMP Manufacturing: Preclinical to Commercial Supply

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Richter-Helm is a Hamburg, Germany–based contract development and manufacturing company with a proven 25-year track record, 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, 160-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 (European Medicines Agency (EMA), the US Food and Drug Administration (US FDA), Agência Nacional de Vigilância Sanitária (ANVISA), and Ministry of Food and Drug Safety (MFDS)) and by numerous customer audits.

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