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Sterile University to Train cGMP Drug Mfg. in China

January 20, 2016

Following the Chinese cFDA’s new policies announced December 1, 2015, expanding opportunities for in-country contract drug manufacturing, PaizaBio and partner Complya Asia have established a formal technical education program in China for producing sterile injectable drugs to Western quality standards following good manufacturing processes (cGMP).
The Trans-Pacific Aseptic Institute of Training (TPA-IT), located in Hangzhou, China, will offer its first class of 50 students March 23-25. The “sterile university” is open to Chinese and Westerners in business or government who are responsible for aseptic manufacturing and seek to elevate their knowledge base. This includes management, facility engineers, filling line supervisors, quality specialists, and microbiologists.
TPA-IT will be held on the campus of Ausia BioTech, a Chinese CMO of sterile injectable drugs. U.S.-based CMO PaizaBio engaged Ausia BioTech as its strategic partner in China. The facility includes a multi-media lecture hall and qualified clean rooms with commercial grade equipment and fully functional HVAC systems.
Stuart Rose, Ph.D., chief executive officer and founder of PaizaBio, said “The launch of the Trans-Pacific Aseptic Institute of Training is well timed given China’s position as the world’s second largest pharmaceutical market and cFDA policy changes intended to fast-track drug approval and allow contract manufacturing of drugs.”
“Despite recent fluctuations in China’s stock market, multi-national pharmaceutical companies can’t ignore China’s growth potential. With the cFDA significantly changing their policies related to drug approval pathways and commercialization, and in particular, opening the doors to contract manufacturing, Western pharma should be looking seriously at expanding manufacturing and sales in China,” Dr. Rose said.
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