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.
WuXi ATU & Iovance in the News
Cooper offers a world-first test of newly approved melanoma therapy to be made in Philly
FDA Approves AMTAGVI for Advanced Melanoma
FDA approves Amtagvi, the first T-cell therapy for melanoma
WuXi ATU receives US FDA approval to manufacture Iovance’s Amtagvi for advanced melanoma
WuXi ATU gains approval for Amtagvi manufacturing at US site
WuXi ATU gains approval for Amtagvi manufacturing at US site
Iovance Opens the Door to Cell Therapies in Solid Tumors With Amtagvi
FDA approval of cancer treatment provides new weapon against tumors
WuXi Advanced Therapies Receives FDA Approval To Manufacture Iovance’s AMTAGVI (Lifileucel) For Advanced Melanoma
WuXi Advanced Therapies’ Philadelphia Site Approved by FDA to Start Manufacturing Iovance’s Melanoma T-cell Therapy
WuXi AppTec subsidiary to manufacture Iovance’s solid tumor TIL therapy in US
FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor
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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