ALBUQUERQUE, New Mexico (U.S.) (October 9, 2016) – The Chinese FDA has made it clear via mandates that China’s burgeoning biopharmaceutical industry must meet cGMP and GXP manufacturing standards if they are to compete globally. To provide the highly technical workforce demanded by aseptic fill-and-finish manufacturing and thus support China’s goal, PaizaBio has opened enrollment for the second session of the Trans-Pacific Aseptic Institute of Training ® (TPAIT®) December 15 and 16 in Hangzhou, China.
PaizaBio, which offers contract aseptic fill-and-finish manufacturing services to multi-national biopharmaceutical companies (MNCs) in China, created TPAIT—China’s first “sterile university”—in 2015 with strategic partner Ausia BioTech. All training takes place in an $8 million, full-scale, dedicated facility on the Ausia BioTech campus in Hangzhou. TPAIT employs an industry-leading curriculum developed and taught by international experts Anne Marie Dixon and Dr. Scott M. Wheelwright.
PaizaBio CEO and Founder Stuart Rose said TPAIT is designed to instill in-depth knowledge of aseptic processing to cGMP/GXP standards among participants such as managers, engineers, operators, quality assurance and quality control personnel, as well as government officials.
“Until now, China and Asia-Pacific lacked full-scale facilities and courses designed to teach their operator workforce and line management in the technical requirements of aseptic processing and the critical nature of maintaining an aseptic environment within manufacturing suites.” Rose explained. “We are pleased to offer world-class training in China to the local population as well as multinationals in China.”
TPAIT combines lecture and hands-on training in the areas of aseptic processing technique, basic microbiology, cleanroom techniques, contamination minimization, environmental monitoring, quality management, and regulatory compliance. Lectures are in English; course materials are provided in both English and Chinese. Space is limited to 50 participants.