WuXi Single-Use Biotech Facility Gets ISPE FOY Nod

By Pharmamanufacturing.com Staff

Apr 14, 2014

WuXi PharmaTech recently announced it received an honorable mention from the International Society for Pharmaceutical Engineering's (ISPE) 2014 Facility of the Year Awards committee for the company's recently completed cGMP cell-culture-based biologics production facility in Wuxi, China. The well-known award program showcases the best of each year's new, state-of-the-art pharmaceutical manufacturing facilities. WuXi is the first company in China to receive this honor.

The judging panel, says WuXi, praised the company’s "very innovative step" of adopting end-to-end single-use technology at its recently completed mammalian-cell-culture-based plant. Such an approach, notes WuXi, “is at the leading edge of Western production plants and makes the facility the most advanced of its type in China.” The design and construction of the plant, says the company, meet the most stringent requirements of Western biopharmaceutical manufacturers, the panel concluded.

"We are pleased to receive this recognition for our state-of-the art biologics production facility in Wuxi city," said Dr. Ge Li, Chairman and CEO of WuXi PharmaTech. "This award is further evidence that our company maintains the highest standards of quality in everything we do. This facility is an integral part of WuXi's CRO/CMO strategy of helping clients to develop and manufacture biologics in China for global markets."

The facility is designed to meet cGMP standards of the U.S., the EU and China, and has been GMP-audited more than 10 times by global clients. WuXi incorporated into the plant two parallel upstream cell culture bioreactor lines, with flexible working volumes of 50L to 2,000L, and one downstream purification production line. This arrangement gives WuXi the capacity, flexibility and quality to handle even the most demanding production projects says the company.

It seems apparent WuXi is making cGMP-compliant facilities a strategic imperative. In February, WuXi PharmaTech announced it received the formal certificate of GMP compliance from the Medical Products Agency (MPA) of Sweden, acting on behalf of the European Medicines Agency (EMEA), for its cGMP drug product manufacturing and analytical testing facilities located in Shanghai, were it produces solid oral dosage forms-tablets and capsules-for use in clinical trials.

WuXi says its Shanghai facility develops and validates methods of analyzing APIs and formulated drug products for properties such as potency, purity and solubility. The company also conducts compound stability tests and tests necessary for the release of APIs and drug products for clinical trial use. Similarly, WuXi delivers services related to regulatory compliance with chemistry, manufacturing and controls, or CMC, requirements, including creation of a readiness testing package for an Investigational New Drug filing and development of a full CMC package.