WuXi Biologics put its new cGMP manufacturing facility into service

| By | Biotechnologies, China, Drug Manufacturing, GMP Standards

WuXi Biologics, a leading global open-access biologics technology platform company, offering end-to-end solutions for biologics discovery, development and manufacturing, announced that its cGMP biologics manufacturing facility in Wuxi city with 30000 L bioreactor capacity entered into full operation. This marks a significant milestone for WuXi Biologics as well as the biologics industry in China.

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 (CFDA).

The new 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.

“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.”

SOURCE: prnewswire.com
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