Breaking News

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.
 
For more information visit: http://tpait88.eventdove.com 

Related Contract Manufacturing:

blog comments powered by Disqus
  • Staying Ahead in the Small Molecule Space

    Staying Ahead in the Small Molecule Space

    Dr. Matthew Moorcroft, VP Global Marketing, Cambrex||September 8, 2016
    Understand what is happening in the market and react accordingly

  • FDA & Drug Development

    FDA & Drug Development

    Rachelle Du2019Souza, Regulatory Heights Inc.||September 8, 2016
    You must perform the necessary due diligence to stay on top of regulatory developments

  • Patent Law  and Contract Manufacturing

    Patent Law and Contract Manufacturing

    Beverly W. Lubit, Member of the Firm, Chiesa Shahinian & Giantomasi||September 8, 2016
    Analyzing the impact of The Medicines Co. vs. Hospira Inc. decision