Biopharmaceutical Development and CGMP ManufacturingClinical to Commercial Supply

摘要

Richter-Helm is a Hamburg, Germany-based contract manufacturing company with a proven 30-year track record, specialized in products derived from bacteria and yeasts. With a high degree of flexibility and a comprehensive range of services, we provide customized solutions. Clients worldwide already have benefited from our commitment to current good manufacturing practice (CGMP) 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 qualified-person (QP) release. We operate two GMP-compliant production plants with bioreactor capacities of up to 1,500 L. Richter-Helm works consistently to the highest standards of pharmaceutical quality, as verified by major regulatory agencies, including the European Medicines Agency (EMA), the US Food and Drug Administration (US FDA), Brazil's Agenda Nacional de Vigilancia Sanitaria (ANVISA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the Canada Health and Ministry of Food and Drug Safety (MFDS) as well as by numerous customer audits.