Cell therapy production facility
In May 2019, Iovance Biotherapeutics announced its plans to build a cell therapy production facility in Philadelphia, US.
The facility will be used to scale the production of autologous tumour infiltrating lymphocyte (TIL) products, including lifileucel. Construction is expected to be completed by 2021.
Iovance’s cell therapy production facility is being developed at 300 Rouse Boulevard at the Navy Yard in Philadelphia. The company has leased 136,000ft² of commercial space at the Navy Yard for the project.
Spanning more than 1,200-acres, the Navy Yard is a former military facility redeveloped as a customisable space for corporate, residential and research and development (R&D) communities. It features several large buildings that are occupied by more than 150 companies.
The Navy Yard holds more than 800,000ft² of privately leased space in the campus for the life sciences sector.
The facility will be designed to utilise modular processes to improve the scalability of Iovance Biotherapeutics’ TIL products. It will enable the company to manufacture products according to the US Food and Drug Administration (FDA) guidelines.
The facility will improve the company’s internal production capabilities, while reducing the cost of operations.
Iovance has obtained a letter of intent from the Philadelphia Industrial Development Corporation (PIDC) for a five-year option to obtain additional space to increase the capacity of the facility.
Iovance uses its proprietary Generation 2 (Gen 2) manufacturing process for the manufacturing and development of TILs for targeting heterogeneous solid tumours. The Gen 2 manufacturing process has shown efficacy in melanoma, cervical, head and neck cancers.
The technology is based on the natural TILs present in the human body, which target specific antigens related to a particular tumour. It was originally developed by Dr Steven A. Rosenberg at the National Cancer Institute (NCI).
The TIL cells are isolated from the patient’s tumour and are cultured and increased in number through tissue culture by stimulating them with interleukin (IL) 2. The Gen 2 manufacturing process takes approximately 22 days to produce the final product, which is cryopreserved and shipped to sites across the US and Europe.
The potent and highly activated TILs are re-infused into the patients after pre-conditioning them to reduce the immune response after the therapy. The TIL therapy has shown significant efficacy in patients with metastatic melanoma in a Phase II clinical study performed at the NCI.
Iovance Biotherapeutics will invest a total of $125m towards the development of the new facility. It will invest approximately $75m over a period of three years for the construction works and installation of the equipment at the facility.
The company has received financial incentives from the Commonwealth of Pennsylvania, the City of Philadelphia and PIDC. The site has been designated as a Keystone Opportunity Improvement Zone, which will offer incentives for business development.
The facility is being developed by Gattuso Development Partners and CRB. Morgan Lewis was the advisor to the company for facility development, while JLL advised on the lease transaction.
Environment and design company Digsau, landscape architecture and construction management company Synterra, and Ensemble Real Estate Solutions and Investments are some of the other companies involved in the project.
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