REPROCELL and BioBridge Global sign Memorandum of Understanding to accelerate global manufacturing services using clinical iPSCs

BioBridge Global expands cell therapy testing laboratory

Demand drives expansion

BioBridge Global celebrated another major advanced therapies milestone March 1, opening its first stand-alone Cell Therapy Testing Laboratory.

More than 50 employees came to celebrate, including CEO Marty Landon; SVP and Chief Operating Officer for GenCure and QualTex, Mark Fite; GenCure biomanufacturing Manager Geoffery Kindt; and Senior Director, Process Development and Cell Therapy Testing, Mari Salmi.

Advanced therapy is a growing area for the organization, and the demand for required specialized testing led to the need for a larger space.

Cell therapy developers are required to include a set of tests that demonstrate their safety, purity, and potency of their products to satisfy regulatory requirements.

“We want to make sure advanced therapy products are safe and effective for the purposes they are intended, so this is something that really fits the mission of BBG to save and enhance lives,” Salmi said. 

This expanded lab will focus on safety, potency, and purity testing, identifying and characterizing therapies fighting a range of ailments, from wounds to cancer. The Cell Therapy Testing Lab also can help with the testing of starting materials used in the earliest stages of advanced therapy development. 

It currently serves 31 clients and approximately 100 different products.

Last year, the cellular therapy lab had a 30% increase in volume and is looking to increase by another 50% in 2024.

Adding two scientists this year

The new, extended lab will begin with a team of five and with plans to add two additional scientists this year. With a dedicated lab team, the organization can now focus on analytical capabilities, increasing customer support, and industry growth.

“The cell therapy arena is expanding so much,” Kindt said “The medicines they are delivering are incredible. Last year there were about eight approvals across the U.S. and E.U. This year they are expecting to double that. This is the environment we are in, it’s just incredibly dynamic.”

The ability to test products for quality, and the ability to be reproduced is something customers are seeking, and the organization plans to deliver with new technology, he said.

‘It is a new environment, and we are super excited to be a part of it,” Kindt said. “With automation to electronic records, to being able to leverage data through an electronic system vs. manual paper, it’s exciting.”

Learn more about BioBridge Global’s Cellular Therapy Testing capabilities here.

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