Leveraging Experience To Support Biologies Manufacturing from Gene to Product

摘要

In recent years, customer requirements for contract development and manufacturing organization (CDMO) services have changed. CDMOs have developed into partners, consultants, and providers of specific services, all preferably coming from a single source.Richter-Helm is one driver of a transparent, flexible, guided, and solution-oriented way of partnership, offering its clients a full-service approach along the entire journey from gene to finished product. The company has a strong heritage and is known for providing best-in-class CDMO solutions including a unique knowledge base in process and analytical validation, process performance qualification (PPQ) procedures, and commercial production of therapeutic proteins and peptides, antibody-like scaffolds(e.g., variable-domain heavy-chain, VHH), bacterial vaccines, and plasmid DNA (pDNA) products. The global pharmaceutical industry expects and requests high-quality standards. Our services are verified regularly by national and international regulatory bodies, including the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), Brazil’s ANVISA health regulatory agency, and South Korea’s Ministry of Food and Drug Safety (MFDS).