WuXi Biologics will harness its growing global network to supply the commercial drug substance and product for Amicus Therapeutics’ Pompe biologic ATB200.
Amicus Therapeutics is developing a therapy consisting of recombinant human acid alpha-glucosidase (rhGAA) enzyme with an optimized carbohydrate structure, administered with a small molecule pharmacological chaperone.
The product, ATB200, will be made by contract development and manufacturing organization (CDMO) WuXi Biologics. The firm, which has been working with Amicus to scale-up the product over the past few years, will be the exclusive drug substance manufacturing partner and will also supply the drug product for an initial five-year term.
According to WuXi Biologics CEO Chris Chen, the work is presently being carried out at the CDMO’s sites in China but other facilities will be used in Europe and the US could be utilized as they come on line as part of its ‘Global Dual Sourcing’ strategy.
The strategy aims to offer a global and supply chain while minimizing technology transfers between companies when using different suppliers. For Amicus, WuXi Biologics will produce the drug substance and drug product each at two sites.
The CDMO has rapidly invested in its global network over the past couple of years, announcing the construction of facilities in Ireland, Singapore, and Massachusetts (US) as well as building out its home Chinese capabilities.
“Dual sourcing within WuXi Biologics is a key strategy,” Chen told this publication. “Our clients can pick two drug substance and two drug product sites from our network in different regions. Hence, we need to build a global network.”
The Amicus contract also falls into WuXi Biologics’ ‘follow-the-molecule’ strategy where the CDMO supports drug development from discovery to commercial manufacture.
“With the follow-the-molecule strategy, we will work with more strategic partners,” Chen said. “But we have some capacity for one off projects as well.”