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TPA-IT: Trans-Pacific Aseptic Institute of Training
TPA-IT: Trans-Pacific Aseptic Institute of Training

China’s pool of workers qualified to manufacture sterile injectable drugs to the highest levels of cGMP quality is about to expand significantly. In March 2016, the Trans-Pacific Aseptic Institute of Training® (TPA-IT) will welcome its first class of students on the campus of Ausia BioTech in Hangzhou, China.

TPA-IT is the brainchild of Stu Rose, founder and CEO of PaizaBio, and Shaofeng Huang, chairman of Ausia BioTech. The two companies are strategic partners in attracting Western pharmaceutical companies to manufacture sterile injectable drugs for the Chinese market, in China, to Western standards of quality.

Aseptic fill-and-finish manufacturing is the most technically challenging of all pharmaceutical manufacturing processes. Rose and Huang want the industry to know that their contract manufacturing organization (CMO) employs people trained at TPA-IT to execute to the exacting standards required by a sterile environment.

TPA-IT is not just for the employees of PaizaBio and Ausia BioTech. TPA-IT’s introductory and advanced courses are open to executives and employees of other CMOs as well as government and regulatory officials from around the world who seek a higher level of proficiency in aseptic manufacturing. This includes the theory and principles of aseptic processing, sterile manufacturing, quality management, and regulatory compliance.

Scott Wheelwriight, PhD
Scott Wheelwriight, PhD

TPA-IT’s home is an $8 million purpose-built, state-of-the-art facility in Hangzhou and includes a lecture hall and hands-on learning experiences in fully equipped clean rooms with commercial grade equipment. Each training course can accommodate up to 50 students. TPA-IT’s curriculum is being developed by and taught by Dr. Scott Wheelwright of Complya Asia. Dr. Wheelwright is an international expert in aseptic manufacturing and celebrated pharmaceutical industry trainer.

Details on the inaugural session of the Trans-Pacific Aseptic Institute of Training are in their final stages. Agenda and registration information will be released shortly. Please contact David Deere at ddeere@paizabio.com for additional information.