Le Lézard
Classified in: Health, Science and technology
Subject: FDA

The U.S. FDA Completed Pre-License Inspection (PLI) of WuXi Biologics cGMP Manufacturing Facilities for Production of TMB-355 (ibalizumab)

SHANGHAI and TAIPEI, Aug. 2, 2017 /PRNewswire/ -- WuXi Biologics (2269.HK), a global leading open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and its partner TaiMed Biologics (4147.TWO) today announced that the U.S. Food and Drug Administration (U.S. FDA) has completed the Pre-License Inspection (PLI) of WuXi Biologics cGMP manufacturing facilities for production of TMB-355 (ibalizumab) with no critical findings. The 5-inspector 13-day inspection covered both drug substance and drug product facilities in the city of Wuxi, China. WuXi Biologics is expected to complete all follow-up actions within three months, which should not impact the BLA review timeline of ibalizumab.

This is first such inspection in China. If ibalizumab is approved, the inspected facilities will be the first cGMP biologics manufacturing facilities in China approved by the U.S. FDA for commercial biologics products, marking yet another milestone that Wu Xi Biologics has set in China. This pending U.S. FDA approval continues to reinforce the strong commitment to quality WuXi Biologics has made to its global client base.

About ibalizumab

Ibalizumab is a humanized monoclonal antibody being developed for the treatment of Multiple Drug Resistant Human Immunodeficiency Virus-1 (MDR HIV-1) infection.  Unlike other antiretroviral agents, ibalizumab primarily binds to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents. US FDA designated ibalizumab as a breakthrough therapy and is currently under review following the acceptance of a Biologics License Application (BLA) in June 2017. The PDUFA date is set to Jan 3 2018.

About TaiMed Biologics

TaiMed Biologics was formed to realize the vision of creating a world-class, innovation-based biotechnology company that will satisfy the unmet medical needs of patients around the world.For more information, please visit http://www.taimedbiologics.com.

About WuXi Biologics

WuXi Biologics is the only open-access biologics technology platform in the world offering end-to-end solutions to empower anyone 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: http://www.wuxibiologics.com.


These press releases may also interest you

at 14:00
FALL RIVER, Mass., Oct. 18, 2017 /PRNewswire/ -- Millstone Medical announced today the addition of on-site Microbiologist, Joshua Browning, to their Fall River sterile packaging facility. Joshua previously served as a Quality Control Analyst,...

at 13:57
OTTAWA, Oct. 18, 2017 /CNW/ - The Honourable Ginette Petitpas Taylor, Minister of Health, will deliver introductory remarks at the 8th Milestones of a Global Campaign for Violence Prevention Meeting hosted by the Government of Canada on behalf of the...

at 13:56
NEW YORK, Oct. 18, 2017 /PRNewswire/ -- Predictive biomarkers are used to provide the best treatment indication with the greater probability of response to a certain specific chemotherapeutic agent, also considering treatment-related side effects....

at 13:45
NEW YORK, Oct. 18, 2017 /PRNewswire/ -- Read the full report: https://www.reportlinker.com/p05151475The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Middle East & Africa and Latin America.Annual...

at 13:33
OTTAWA, Oct. 18, 2017 /CNW/ - If you're planning on bringing pesticides into Canada, you should know that Health Canada is changing the rules for importing pesticides for personal use. Unregistered pesticides brought in from other countries have...

at 13:27
NEW YORK, Oct. 18, 2017 /PRNewswire/ -- Read the full report: https://www.reportlinker.com/p098386The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World.Annual estimates...

News published on 2 august 2017 at 21:23 and distributed by: