Software Advances Mass Customization for Cell and Gene Therapies

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In an interview, Fabian Gerlinghaus of Cellares outlines a paradigm change in both hardware and software, regulatory expansions, and some positive cost outcomes for the CGT field.

A trade imbalance between the supply and demand sides of the advanced therapy medicinal products (ATMP) field sees demand for these often-curative cell and gene therapies far outstripping supply, manufacturing being one of the main bottlenecks.

Processes that have progressed farthest have been modular, semi-automated processes that still contain manual handling steps. “This style of process is inherently limiting,” Peter Yates, director of Product Management–Personalized Medicine, Cell and Gene, Lonza, told Pharmaceutical Technology in a previous interview (1). “These processes may work well in early clinical trials where the numbers of doses produced is relatively small and demand can be handled with a specialized manufacturing team. However, the problems become abundant when trying to increase throughput.”

One company trying to open that bottleneck is San Francisco-based Cellares, a self-titled Integrated Development and Manufacturing Organization (IDMO) that provides cost savings, scalability, and drug product quality improvements versus traditional manufacturing techniques. In an interview with Pharmaceutical Technology, Fabian Gerlinghaus, CEO and co-founder, Cellares, recalls walking the exhibit floors at cell therapy conferences in 2018, noting that “there was just nothing on the market that I thought would actually be able to solve the scalability and the cost and the quality problems. And at that point, Omar and I teamed up to start Cellares, and build a technology platform that actually does solve all three of these issues.”

Recently, the company announced that its first Cell Shuttle has been deemed current Good Manufacturing Practice (cGMP)–compliant, marking a major milestone as it prepares for clinical readiness by the end of 2024.

Watch Part 2 of our interview with Gerlinghaus below to learn more about Cellares’ Cell Shuttle platform and how they are innovating in a complex and highly regulated space.