Singapore: Gilead Sciences and WuXi PharmaTech have entered into a strategic partnership to conduct analytical and stability studies of small-molecule new chemical entities to support global marketing applications and commercial products.
Under the agreement, WuXi will equip and operate a dedicated, fully cGMP-compliant 12,500-square-foot analytical testing facility in Shanghai. 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 commercial products; and reference standard qualification.
“This strategic partnership further strengthens our close, broad-based collaboration with Gilead over many years,” said Dr Ge Li, chairman and CEO of WuXi PharmaTech. “WuXi is determined to enable our innovative partners like Gilead through our open-access R&D platform, and we are very honored to help advance some of the most innovative medicines faster to patients.” “The opening of this analytical and stability testing center is an important milestone in the ongoing long-term relationship between Gilead and WuXi,” said Bob Miller, vice president, Quality Assurance, Gilead Sciences.