January 07, 2022 – Philadelphia. WuXi Advanced Therapies (WuXi ATU) announced it has successfully completed a remote European Medicines Agency (EMA) inspection for its advanced therapies testing facility at 400 Rouse Boulevard in its Philadelphia Navy Yard Campus, and received confirmation that the issuance of GMP certificate is in progress. This certification will not only mark an important milestone for WuXi ATU, the advanced therapies business unit of WuXi AppTec, on its global quality system, but it will underscore its commitment to providing cell and gene therapy Contract Testing Development and Manufacturing Organization (CTDMO) services with the highest standards for customers.
The issuance of GMP certificate followed a remote inspection conducted by Ireland’s Health Products Regulatory Authority (HPRA) in December 2021. The comprehensive inspection covered Virology and Mycoplasma Quality Control testing and the facility’s entire quality system. The positive inspection outcome will support ongoing submissions to the EMA for new biologics and cell and gene therapy products from our global commercial partners.
The new state-of-the-art testing facility, which officially opened two months ago, has tripled WuXi ATU’s capacity for testing to meet the growing demand among the cell and gene therapy industry. The Biosafety Testing team has significant expertise in assay development, biologics safety testing, viral clearance and commercial lot release assays and will benefit from increased capacity with this new testing facility expansion in Philadelphia.
“At WuXi ATU, delivering the highest quality standards for our customers and meeting global regulatory standards are among our top priorities.” said Dr. David Chang, Chief Executive Officer of WuXi ATU. “The EMA certificate for biosafety testing at our new Philadelphia facility is a testimony to our commitment to being a trusted partner to our customers. As demand for cell and gene therapies grow, we will further enhance our CDMTO platform to better enable customers in Philadelphia and beyond to bring ground-breaking therapeutics to patients as quickly, reliably and consistently as possible.”
As a CTDMO with global operations, WuXi ATU’s unique business model integrates powerful testing capabilities with its advanced therapies process development and manufacturing platforms, such as TESSA technology for AAV manufacturing and XLenti stable solutions for lentiviral manufacturing. This allows all assay development, biosafety, viral clearance, and product release testing to be completed in-house, shortening customers’ timelines for the approval of advanced therapies. WuXi ATU has supported more than 1,700 customer submissions for biosafety testing through industry-leading testing and analytical assay development, enabling the delivery of more effective and accessible advanced therapies to patients.
About WuXi Advanced Therapies (ATU)
WuXi Advanced Therapies, a global Contract Testing Development and Manufacturing Organization (CTDMO), is the advanced therapies business unit of WuXi AppTec and offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies for customers worldwide. Our technologies, automation platforms and service solutions advance pre-clinical research and accelerate the timeline to GMP manufacture, while integrated GMP manufacturing and testing platforms reduce time to market, maintaining high titres, high levels of quality assurance and full regulatory compliance. Ultimately, our complete end-to-end solutions support pioneering companies to deliver breakthrough cell and gene therapies to the patients who need them. For more information, please visit https://www.advancedtherapies.com.
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