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SUZHOU, China, June 16, 2020 –WuXi Biologics (“WuXi Bio”) (2269.HK), a global company with leading open-access biologics technology platforms, announced that its facility in Suzhou has received European Medicines Agency (EMA) GMP certificate, following that from China National Accreditation Service for Conformity Assessment (CNAS) and China Inspection Body and Laboratory Mandatory Approval (CMA). This marks a great step for the company to be one of few third-party biosafety testing providers certified by EMA GMP standards in China even Asia-Pacific region.
This EMA GMP certificate was issued following an inspection conducted by Poland’s Chief Pharmaceutical Inspector in December 2019. The inspection covers not only biosafety testing services specifically provided for Henlius’ HLX02 (Trastuzumab), but also the facility’s entire quality and management system, related instrumentation and equipment. HLX02 (Trastuzumab) has been adopted a positive opinion from Committee for Medicinal Products (CHMP) of EMA recently.
As one of the largest third-party biosafety testing providers in the Asia-pacific region, WuXi Biologics (Suzhou) meets different sets of compliance standards in the US, Europe, Japan and China. It offers complete services for CHO cell line characterization testing (primary cell bank, master cell bank, working cell bank, etc.), bulk lot release (mycoplasma, retrovirus and general virus screening) and viral clearance. Equipped with a state-approved BSL-2 biosafety laboratory, the facility has established rigorous platforms for biosafety testing and viral clearance.
Dr. Chris Chen, CEO of WuXi Biologics, commented, “The EMA certificate is a powerful proof of our globally accepted and premier quality system as well as proprietary technology platforms at our Suzhou facility. We’ll continue to improve our capabilities and quality to offer more comprehensive biosafety testing services to enable global partners and benefit patients worldwide.”
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform 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 strong value proposition to our global clients. As of December 31, 2019, there were a total of 250 integrated projects, including 121 projects in pre-clinical development stage, 112 projects in early-phase (phase I and II) clinical development, 16 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany and Singapore exceeding 280,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com