Scalable Cell-Therapy Manufacturing Technology

A U.K. company working to solve one of the biggest problems in cell therapy manufacturing is moving towards commercializing their technology. MFX (formerly MicrofluidX), which is working to solve the challenge of scaling up manufacturing processes, is now sharing its technology with early academic, biotech, and pharmaceutical users.

MFX has developed the Cyto Engine Stack and aims to improve scalability by using cassettes to avoid the need to do new experiments at each volume. Each cassette has a similar microenvironment, regardless of size, to make it easy to scale up for manufacturing volumes–either by using a larger cassette or connecting and stacking multiples.

“What’s unique is the simplicity and scalability of the cassette technology,” explains Lindsey Clarke, PhD, VP of commercial strategy.

Stacked into a Single Instrument

Multiple bioreactor cassettes can be stacked into a single instrument that controls and monitors each process independently. The smallest individual cassettes have volumes of between 1.5 and 12ml for early research and process development. The largest cassettes are designed to produce enough cells for a single dose of autologous CAR-T therapy.

“You can start simple, as you might in a flask, to understand the biology and then scale up to larger volumes without changing the process,” explains Clarke.

“The early proof-of-concept experiments you can do without automation or process monitoring,” points out Clarke. “It’s a barrier to use if you automate too early so you can automate when the time is right.”

The need to improve manufacturing processes in the emerging field of cell therapy has helped MFX secure funding to bring their product to market from sources including U.K.’s national innovation agency.

MFX recently announced it had been awarded £685,000 ($868,785) via Innovate UK’s Investor Partnership program. The company says the money will go toward helping develop the Cyto Engine Stack.

The company’s aim, according to Clarke, is to develop monitoring technologies useful to the industry before launch, such as next-generation imaging or tools to monitor metabolites.

“It’s going to depend on the cell populations and there are a lot of different processes [in use currently], so we’re working with a variety of early-access partners to work out the best fit,” she says, adding that the company hopes to release their first Cyto Engine product in 2025.


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