For 20+ years, members of the CMC (Chemistry Manufacturing and Control) team have supported and are supporting numerous pharmaceutical companies to ensure the timely development and manufacture of high-quality drug substances and drug products for non-clinical- and clinical studies. The support includes:
» CMC management and strategy development Including CMC development strategy, project management, due diligence and gap analysis, CDMO (Contract Development and Manufacturing Organization) selection and management, QbD (Quality by Design) support,
» Drug Substance process development Including process development and scale-up, tech transfer, and design of stability studies
Open Orphan (LON:ORPH) was founded in 2017, with the goal of rapidly building Europe’s leading pharma services company by a management team with extensive industry and financial expertise. The company comprises of two commercial specialist CRO services businesses (Venn Life Sciences and hVIVO) and is also developing a genomics data platform business (Genomic Health Data).