WuXi Biologics’ cGMP biologics manufacturing facility in Wuxi, with 30,000 L bioreactor capacity, began full operations, a significant milestone for the company as well as the biologics industry in China.

In April 2015, WuXi Biologics invested $150 million to build the new biologics manufacturing facility and in September 2016, the first phase of construction was completed with two 1,000 L disposable bioreactors for perfusion processes. The second phase for the cGMP facility included an additional fourteen 2,000 L disposable bioreactors for fed-batch cell culture.

The new 500,000 sq.-ft. facility quintuples the company’s existing manufacturing capability and will support the biologics commercial manufacturing pipeline for its global partners. The newly added capacity will address the needs of Chinese companies as biologics contract manufacturing for Chinese companies is now being piloted by the China Food and Drug Administration (CFDA).

In 2012, WuXi Biologics completed its first biologics drug substance and drug product manufacturing facilities in Wuxi, which became the first in China that met cGMP standards of the U.S., the EU, and China. In August 2017, the U.S. FDA completed the Pre-License Inspection (PLI) at this facility where TaiMed Biologics’ ibalizumab, for the treatment of multi-drug resistant HIV, was manufactured. This inspection makes WuXi Biologics the first Chinese company to receive a U.S. FDA PLI or cGMP inspection for biopharmaceuticals.

“We are very pleased that it only took us a little more than two years from our own innovative concept of using single-use bioreactors for commercial manufacturing facilities to actual completion of a global standard state-of-the-art facility in Wuxi city. This new facility design with a lower capital expenditure and shorter facility timeline compared to that of traditional biologics commercial manufacturing facilities, represents a novel design for facility-of-the-future, which has been emulated by several companies globally,” said Dr. Chris Chen, chief executive officer of WuXi Biologics. “The new site in Wuxi delivers to our customers additional capacity, greater flexibility and higher efficiency.”

Dr. Ge Li, chairman of WuXi Biologics said, “We are very pleased with the new facility. We will continue to enhance WuXi Biologics’ capabilities and capacities in integrated biologics discovery, development and manufacturing to accelerate biologics development for our global partners and ultimately benefit patients worldwide.”