13 February 2019 | News
As per the strategic agreement, WuXi Biologics will be the exclusive commercial drug substance manufacturing partner and key commercial drug product supplier.
WuXi Biologics, a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and Amicus Therapeutics , a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases, announced that the companies have entered into an exclusive commercial manufacturing partnership for Amicus' Pompe biologic ATB200.
Per the strategic agreement, WuXi Biologics will be the exclusive commercial drug substance manufacturing partner and key commercial drug product supplier. WuXi Biologics will enable and support Amicus with its "Global Dual Sourcing within WuXi Biologics" strategy and manufacture both the drug substance and drug product, each at two sites across its global commercial supply network in EU, China and US.
This approach effectively ensures a global and robust supply chain while at the same time minimizes the intra-company technology transfer risk associated with traditional approaches of using different suppliers. The contract has an initial five-year term and then automatically renewed every two years until cancelled.
This agreement showcases the strong commercial manufacturing expertise and global premier quality system of WuXi Biologics as well as its powerful "Follow-the-Molecule" strategy that enables a global client base from discovery to commercial manufacture. The ATB200 program was initiated at WuXi Biologics in 2012 and now progresses through a pivotal study enabled by the global leading technology platform and unparalleled manufacturing capacity at WuXi Biologics.