WuXi Vaccines' First Drug Substance Facility in China Released for GMP Manufacturing
SUZHOU, China, July 28, 2023 /PRNewswire/ -- WuXi Vaccines, a leading global vaccine CDMO (Contract Development and Manufacturing Organization), today announced the successful GMP release of its CHO cell-based drug substance (DS) manufacturing facility located in Suzhou, China. DS production has already begun at the facility. The GMP release of its first DS facility in China enhances WuXi Vaccines' capability in providing global partners with comprehensive end-to-end solutions, and demonstrates the company's continued commitment to meeting increased demand for vaccine development and manufacture, as well as expanding vaccine accessibility around the world.
The DS facility employs the proven and reliable CHO cell-culture platform, and utilizes single-use bioreactors up to 1000L – a combination that enhances both the efficiency and quality of drug substance production. To further cater to the diverse needs of global partners, the Suzhou site is also expanding manufacturing capability by developing its DS capacity based on microbial and viral platforms up to BSL2, and building a fill & finish facility that will offer liquid, lyophilization, suspension and emulsion processes. Dedicated to maintaining the highest levels of quality and safety, the Suzhou site upholds stringent global cGMP standards and complies with the regulatory guidelines of the U.S. FDA, EU EMA, China NMPA, and WHO.
Mr. Jian Dong, CEO of WuXi Vaccines, commented, "The release of the drug substance facility at our Suzhou site and the start of manufacturing marks a major milestone for WuXi Vaccines. Leveraging our expertise, advanced facilities, and innovative technology platforms, while adhering to global cGMP standards and regulatory guidelines, we are primed to meet the rising demand for vaccine development and manufacture, and advance the availability of safe and effective vaccines worldwide."
About WuXi Vaccines
WuXi Vaccines is a leading contract development and manufacturing organization (CDMO) that focuses on vaccine development and manufacturing. It provides world-class integrated development and manufacturing platforms to expedite partners' vaccines to the clinical stage and the market, regardless of the vaccine modality (i.e., protein, virus, VLP, DNA, mRNA/RNA). With its technical expertise, broad regulatory knowledge, premium quality system, advanced CMC development capabilities, multiple production platforms (mammalian, microbial), and extensive GMP manufacturing capacities, WuXi Vaccines provides an end-to-end service – from vaccine discovery and development to large-scale commercial production and distribution. The company can enable any global partner to deliver critical vaccines anywhere in the world, making it an essential partner in protecting public health. For more information about WuXi Vaccines, please visit: https://wuxivaccines.com.
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