Sterile University To Train Drug Manufacturing Workforce In China

In the wake of 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 to educate a workforce capable of 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, the site of the G20 Summit in September 2016, will welcome its inaugural 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 leading Chinese contract manufacturing organization (CMO) of sterile injectable drugs, at their $8M, full-scale facility initially established for training their employees to the highest level of aseptic technique. When U.S.-based contract manufacturing organization (CMO) PaizaBio engaged Ausia BioTech as its strategic partner in China, the facility’s mission took on a global scope and was renamed the Trans-Pacific Aseptic Institute of Training. The facility includes a state-of-the-art, multi-media lecture hall that accommodates up to 50 students and qualified clean rooms with commercial grade equipment and fully functional HVAC systems.

PaizaBio has tapped global experts to develop the curriculum and lead training, which will focus on the theory and principles of sterile processing, quality management and regulatory compliance. Scott Wheelwright, PhD, founder and principal consultant of Complya Asia, is the lead instructor; he has more than three decades of experience in drug manufacturing and quality assurance. TPA-IT’s curriculum was developed by Anne Marie Dixon of Cleanroom Management Associates. Dixon is a world-renowned expert in cleanroom management and has trained more than 850,000 cleanroom technicians and managers.

Stuart Rose, PhD, CEO 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’sgrowth 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,” Rose said.

“We (PaizaBio) anticipate that growth-oriented Western companies will take advantage of these broader opportunities to expand operations in China, which will increase demand for a local workforce prepared to deliver Western regulatory and quality standards in aseptic processing. With TPA-IT, we will facilitate the training of this highly technical workforce required by the quality-driven biopharmaceutical industry,” Rose added.

TPA-IT’s inaugural session in March will be taught in English with subsequent sessions in Chinese. The tuition per attendee are: Early Registration by January 15 – ¥5360 ($900 US), Advanced Registration by February 19 – ¥6030 ($1,005 US) and Standard Registration after February 19 – ¥6700 ($1,120 US). A 10 percent discount is given to organizations sending more than one person. Discounted rates at local hotels are available. For more information, visit http://tpait88.eventdove.com.