Iovance opens PA cell therapy plant; produces first batch of lifileucel

The $85 million Iovance Cell Therapy Center (ICTC) has opened its doors at the Philadelphia Navy Yard with capacity to supply thousands of patients per year.

Iovance celebrated the opening of its 136,000 square-foot commercial-scale production facility, commissioned in 2018 at a cost of around $85 million, this week.

“Since Iovance was founded, we have been dedicated to advancing novel cell therapies for patients with solid tumor cancers,” Iovance CEO Frederick Vogt said.

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“A little over two years after breaking ground, iCTC is now one of the largest cell therapy manufacturing facilities in the world and may ultimately house hundreds of employees.”

He added: “We now have the capacity to supply broad access to TIL therapies for patients.”

Iovance is developing several tumor infiltrating lymphocyte (TIL) cell therapies for various cancers. Lead product lifileucel has US FDA regenerative medicine advanced therapy (RMAT) designation and is in pivotal trials for both melanoma and cervical cancer.

Its program LN-145 is looking at using lifileucel in patients with metastatic non-small cell lung cancer, and the first clinical batch has been successfully manufactured and delivered from the new facility, the firm said.

“Moving forward, we are diversifying between internal and external TIL manufacturing for clinical studies, and iCTC remains on track to provide commercial supply upon potential product approval,” COO Igor Bilinsky said. “Establishing our internal manufacturing capabilities is a top priority at Iovance to ensure broad access to and reduce the costs of Iovance TIL cell therapy.”

Iovance has previously inked deals with contract development and manufacturing organizations (CDMOs) for clinical supply of its TILs, specifically WuXI Apptec which produces TILs from its Commerce Center 3 facility within WuXi Advanced Therapies’ cell and gene therapy site in the Philadelphia Navy Yard.

Manufacturing improvements

TILs are based on a 22-day process. This involves the isolation of TIL cells from a patient’s tumor and then expanding them by stimulating them ex vivo. The cells are fragmented in a minimalized cell culture system for the first 11 days before rapid expansion begins. On day 16 the cells are split into multiple flasks, and day 22 they are harvested.

However, the firm has looked to the opening of the Philadelphia, Pennsylvania plant as an opportunity to improve the process further and reduce costs.

In January 2020, Michelle Simpson-Abelson, then principal scientist at Iovance, said: “The thought process of having our own manufacturing facility and being able to tweak the process is to allow it to be as accessible to as many patients as we can.”