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news.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.
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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.
WuXi PharmaTech chairman and CEO Ge Li said: "This strategic partnership further strengthens our close, broad-based collaboration with Gilead over many years.
"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."
Gilead Sciences vice president of quality assurance Bob Miller said: "The opening of this analytical and stability testing center is an important milestone in the ongoing long-term relationship between Gilead and WuXi."