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A new facility to be built in the Philadelphia Navy Yard will support commercial production for autologous tumor-infiltrating lymphocyte cell therapy products from Iovance Biotherapeutics.
Iovance Biotherapeutics, a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, announced in a May 29, 2019 press release that it has entered into a lease agreement to build an approximately 136,000-ft2 commercial-scale production facility in Philadelphia for commercial and clinical production of autologous TIL products, including its candidate lifileucel. The facility will allow production according to FDA guidelines and is designed to provide scalability using modular processes. The facility will be designed and built for an ultimate maximum capacity to manufacture TIL products for several thousands of patients annually.
The lease agreement and construction of the new Iovance facility at the Navy Yard is expected to ultimately create employment opportunities for several hundred individuals in Philadelphia once at full capacity. Iovance expects to invest approximately $75 million over three years for equipment and construction of the manufacturing suites. The facility is expected to be completed in approximately two years.
“We are very excited to initiate building our commercial manufacturing facility in Philadelphia. The 22-day Iovance Gen 2 TIL therapy process is robust and scalable, and has led to impressive responses in melanoma, cervical, and head and neck indications,” commented Maria Fardis, president and CEO of Iovance, in the press release. “Building our own internal production capabilities will help us reduce the cost of operations, which is necessary for offering broad access to TIL therapy. We look forward to beginning construction within the next few weeks. Our intention is to continue collaborating with our existing contract manufacturing organizations while we complete the facility in 2021.”
Iovance’s autologous TIL therapy involves collection of a tissue sample from a patient, which is shipped to a facility where immune cells can be isolated and amplified to populations numbering in the billions of cells. This diverse, polyclonal population of active T-cells are then cryopreserved and shipped to sites across the United States and Europe for infusion into the patient.