WuXi Biologics Initiated cGMP Manufacturing in the World’s Largest Biologics Manufacturing Facility Using Only Single-Use Bioreactors
WUXI, China, December 6, 2017 — WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, today announced that its cGMP biologics manufacturing facility in Wuxi city with 30,000 L bioreactor capacity entered into full operations. This marks a significant milestone for WuXi Biologics as well as the biologics industry in China.
In April 2015, WuXi Biologics announced a $150 million plan to build a state-of-the-art biologics manufacturing facility in Wuxi city. In September 2016, the first phase of construction was completed with two 1,000 L disposable bioreactors for perfusion processes, making it the largest perfusion biologics manufacturing facility using disposable bioreactors in Asia. Just 15 months later, a cGMP campaign has been started in the second phase of the cGMP facility, now equipped with additional fourteen 2,000 L disposable bioreactors for fed-batch cell culture.
The new facility quintuples the existing manufacturing capability of WuXi Biologics. This facility will support the robust biologics commercial manufacturing pipeline coming from its global partners and further strengthens WuXi Biologics’ position as a global premier biologics manufacturer. In addition, the newly added capacity will address the urgent needs of Chinese companies as biologics contract manufacturing for Chinese companies is recently being piloted by the China Food and Drug Administration (The CFDA has been renamed NMPA).
The new 500,000 sq. ft. manufacturing facility will complement WuXi Biologics’ existing biologics manufacturing capabilities. In 2012, WuXi Biologics completed its first state-of-the-art biologics drug substance and drug product manufacturing facilities in Wuxi city. This facility was the first in China that met cGMP standards of the United States, the European Union, and China. In 2014, the facility received the Honorable Mention Award “Facility-of-the-Year” by International Society for Pharmaceutical Engineering (ISPE), a first for China. In August 2017, the U.S. FDA completed the Pre-License Inspection (PLI) at this cGMP manufacturing 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 commented, “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.”
About WuXi Biologics
WuXi Biologics, a Hong Kong-listed company, is the only open-access biologics technology platform in the world offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and value proposition to our global clients. For more information on WuXi Biologics, please visit www.wuxibiologics.com.