Contract manufacturing and packaging help bring orphan drug to market

摘要

Galafold was recently approved in Europe as a first-line, long-term monotherapy for Fabry disease in patients with amenable mutations. The Almac Group has helped Amicus Therapeutics Inc. with Galafold's packaging along the way, first working with the drug company in 2009 when it needed an outsourcing partner for Phase Ⅲ clinical manufacturing and packaging of its solid oral AT1001 compound. Almac's Pharmaceutical Development and Clinical teams have continued to work with Amicus to advance the drug product through scale up, registration, and now into commercial supply.