Biologics Manufacturing from Gene to Product

With 35 years of experience in biomanufacturing, Richter-Helm BioLogics provides best-in-class solutions as a contract development and manufacturing organization (CDMO). We offer high-quality services from process and analytical method development to commercial manufacturing that is compliant with current good manufacturing practices (CGMPs). Such work requires expertise in process and analytical validation and process performance qualification (PPQ) to produce therapeutic proteins, peptides, antibody-like scaffolds, bacterial vaccines, and plasmid DNA (pDNA). Richter-Helm’s services are inspected routinely by regulatory authorities, such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), to maintain high quality standards.

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