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PaizaBio Founder and CEO Stuart Rose
PaizaBio Founder and CEO Stuart Rose

I met Shaofeng Huang seven years ago while CEO of OsoBio, a U.S. aseptic fill-and-finish CMO. A mutual friend suggested we connect because our businesses were similar, albeit half a world away. Intrigued by the opportunity, Shaofeng traveled from Hangzhou, China, to Albuquerque, New Mexico, to make it happen. So began our interesting and transformative relationship.

In 2008, Shaofeng had just assumed leadership of Ausia BioTech, a China-based aseptic fill-and-finish company his mother had founded in 1993 with an Australian partner. She eventually assumed full ownership, and when she retired, chose Shaofeng to take over what was, even then, among the largest pharmaceutical CMOs in China.

Even with Ausia BioTech’s success, Shaofeng was not satisfied. He recognized that to be globally competitive, he needed to understand the Western way of doing business and to implement them and Western quality standards, specifically FDA and EMA regulatory standards, in his operation. As I had been working on projects in China since 1990 and understood the opportunities and barriers, I agreed to work with him.

Shaofeng Huong, Ausia BioTech
Shaofeng Huang, Ausia BioTech

Or maybe, he agreed to work with me.

Over the next seven years, Shaofeng and I continued to meet and share ideas on how best to make Ausia BioTech a premiere global CMO focused on aseptic fill-and-finish. One of the first steps Shaofeng took was upgrading his manufacturing facilities, installing U.S. and European-made production equipment, including his latest investment, state-of-the-art lyophilization technology from Germany. An engineer, he also began designing improvements to equipment, including a unique stopper feeder.

Patented sterile stopper feeder
Patented sterile stopper feeder

To ensure an exceptionally trained workforce, Shaofeng established an $8 million full-scale Sterile University to train employees and Chinese officials in the theory and principles of aseptic processing, quality management and regulatory compliance. The Sterile University is now being expanded into the Trans-Pacific Aseptic Institute of Training® (TPA-IT), offering a world-class aseptic processing training curriculum to people from around the world. Additionally, he has hired a multi-lingual team to make working with Western customers more seamless.

 

SterileU Lecture3
Sterile University trains aseptic workforce

Recognizing the critical imperative of trust and transparency with Western customers, Shaofeng implemented and then customized Hitachi’s HITPHAMS® MES software system, which gives customers real-time, remote access to both data and video of their products in production. It does not matter where in the world the customer is located, they can see their product on the line and also monitor data on line speeds, vials per minute, confirm the weight of each vial, and more. I don’t know of any other pharmaceutical company or CMO in the world using a system like this.

Shaofeng no longer needs my advice. And, I am no longer with OsoBio. Shaofeng and I are now partners in a new venture, PaizaBio, which is focused on opening China’s vast sterile injectables market to Western pharmaceutical companies. Now Western pharma can manufacture for China, in China, to Western quality standards with PaizaBio and our strategic partner, Ausia BioTech.

I couldn’t have a better partner.