- Wuxi Biologics Inc., a top biologics drugmaker in China, has started manufacturing operations at what it claims is the world's largest facility for the production of biologics using only single-use bioreactors.
- By bringing the site online, Wuxi says it has boosted its production capability five-fold, positioning the company to help meet the forecasted growth in demand for contract drug services in China.
- All told, the new 500,000 square-foot facility boasts 30,000 L of bioreactor capacity, spread across two 1,000 L bioreactors for perfusion processes and 14 2,000 L bioreactors for batch cell cultures.
As the Chinese pharmaceutical market continues to grow in size, Wuxi Biologics has attracted attention as one of the top companies riding that wave of investment.
Wuxi, which is registered in the Cayman Islands and owned by Wuxi AppTec, debuted on the Honk Kong stock exchange in June, raising $511 million in an oversubscribed initial public offering. The contract manufacturer says it commands a 48% share by revenue of the market for biologics services in China, and has worked with 12 of the largest 20 pharmaceutical companies.
Revenues during the first six months of 2017 rose by nearly 60% to 654 million yuan (about $99 million).
Wuxi first announced plans to build and expand the Wuxi city biologics manufacturing plant in April 2015, committing to investing $150 million in the site. Just over two years later, Wuxi has started cGMP manufacturing at the site to support its contract business.
In addition to the plant in Wuxi city, the CDMO has locations in Shanghai and Suzhou, China.
Currently, most of Wuxi's biologics projects are in pre-clinical or early-phase clinical development, although it has 6 projects in Phase 3 and 1 project in commercial manufacturing.
The company's site in Wuxi recently became the first drug product facility to be inspected by the Food and Drug Administration as part of a pre-license inspection ahead of an approval decision for a new drug. In this case, a Taiwanese drugmaker called TaiMed Biologics contracted Wuxi for production of an HIV candidate called ibalizumab. A decision on approval had been expected at the beginning of 2018, but has since been delayed until April 3.
If ibalizumab wins FDA approval, it would be the first biologic OK'd for sale in the U.S. with commercial manufacturing in China.
Wuxi's expansion mirrors the rapid growth of the Chinese pharmaceuticals sector, now the world's second largest market. The Chinese government has recently taken several major steps to streamline the regulatory process, including giving companies greater scope to tap contractors for manufacturing of drugs up for approval in China.
"In the past, even for local companies, the one who sells the drug and the one who manufactures the company had to be the same in China," said Sean Cao, managing director of C-Bridge Capital, in a recent interview with BioPharma Dive.
While the prospects for China's contract manufacturing market — and Wuxi — look bright, the increased role played by Chinese companies in the drug supply chain has attracted the FDA's attention. Inspections of production facilities in China are up, and Chinese plants have received significantly more warning letters for GMP violations n recent years than in the past.