Outourced Pharma
WuXi Advanced Therapies Receives FDA Approval To Manufacture Iovance’s AMTAGVI (Lifileucel) For Advanced Melanoma
WuXi Advanced Therapies Congratulates Long-Term Partner
Iovance’s AMTAGVI™ (lifileucel) received U.S. FDA accelerated approval on February 16, 2024. AMTAGVI™ is the first T cell therapy and the only one-time, individualized cell therapy to receive FDA approval for a solid tumor cancer.
Read Iovance Press ReleaseWuXi Advanced Therapies Philadelphia Site Approved to Manufacture Iovance’s AMTAGVI™ (lifileucel) for Advanced Melanoma
Iovance reached a significant milestone when it received accelerated approval of AMTAGVI™. At the same time, our site became the first external manufacturing site and third-party CTDMO to be approved by the FDA for commercial manufacturing and release of an individualized T cell therapy for solid tumor cancer in the U.S.
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Your Partner from IND to BLA
Our partnership with Iovance began in 2015,
and we have supported them through clinical trials to commercialization.
WuXi Advanced Therapies is unique in that we offer both clinical and commercial scale contract testing, development and manufacturing services here in the United States. No matter where you are in your product lifecycle, we can help you accelerate your path to market.
Our expert and experienced team is available for process and analytical method development, accelerated IND-enabling studies and clinical production. We also have the supporting infrastructure, capacity and proven quality systems to meet commercial demand.
All services are delivered at our modern, expertly designed and fully equipped facilities at the Navy Yard in Philadelphia, Pennsylvania.
Our track record includes over 40 INDs/BLAs, more than 3,000 GMP batches, and lot release for 26+ commercial programs.
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