New facility will offer services including analytical method development, commercial API and drug product testing, drug products for registration and reference standard qualification
Gilead Sciences and WuXi PharmaTech have entered into a strategic partnership to conduct analytical and stability studies on small-molecule new chemical entities to support global marketing applications and commercial products.
Under the terms of the agreement, WuXi will equip and operate a dedicated, fully cGMP-compliant 12,500ft2 analytical testing facility in Shanghai, China.
The facility will provide analytical and stability services, including analytical method development, transfer and validation for IND/NDA submissions, commercial API and drug product testing, stability studies of APIs, drug products for registration and reference standard qualification.
‘This strategic partnership further strengthens our close, long-term collaboration with Gilead,’ said Ge Li, Chairman and CEO of WuXi PharmaTech. ‘WuXi is determined to work with innovative partners such as Gilead through our open-access R&D platform, and we are very honoured to advance some of the most innovative medicines and get them to patients faster.’
‘The opening of this analytical and stability testing centre is an important milestone in the ongoing long-term relationship between Gilead and WuXi,’ said Bob Miller, Vice President of Quality Assurance, Gilead Sciences.