California Biotech Iovance Biotherapeutics will construct a facility for the commercial production of autologous cell therapies.

Cell therapy company Iovance Biotherapeutics is developing autologous treatments, including Lifileucel (LN-144), an autologous -nfiltrating lymphocyte (TIL) product under development for the treatment of metastatic melanoma. Although its headquarters are in California, the company announced that it will shortly be breaking ground on a new 136,000-ft² facility in Philadelphia that will enable lab-to-commercial production of autologous TILs.

Iovance says it will be investing approximately $75 million over the next several years in the commercial manufacturing facility for the production of TILs. Its 22-day Gen 2 TIL therapy process is robust and scalable and has led to impressive responses in melanoma, cervical and head and neck indications, according to company CEO Maria Fardis. The intent behind building in-house production capability is to reduce the cost of operations.

The plant is expected to be completed in 2021 and have the capacity to produce TIL treatments for up to several thousand patients per year. It will employ several hundred people. In addition to Lifileucel, Iovance hopes to receive FDA approvals for other cell therapies it has under development for the treatment of patients with locally advanced, recurrent or metastatic cancers, including cervical, head and neck and non-small cell lung cancer.

Both Novartis and Bluebird Bio are in the process of building gene therapy manufacturing facilities in Durham, North Carolina. Novartis is investing $55 million in a manufacturing plant for the production of recently approved Zolgensma, a treatment for pediatric patients with spinal muscular atrophy. The Bluebird Bio facility will produce Zynteglo, a European-approved treatment for transfusion-dependent β-thalassemia.