MicrofluidX is an early-stage developer of cell and gene therapy manufacturing platforms that aims to streamline the transition from laboratory research to large-scale GMP manufacturing.

In Episode #31 of the Speed to Data podcast, Key Tech hosts Andy Rogers and Director of Strategy Lei Zong speak with Dr. Lindsey Clarke, MicrofluidX Vice President of Commercial, about the company’s solution to advanced therapy commercialization.

Need to know

Cell and gene therapies are revolutionizing medicine — Since the 1990s, these therapies have opened new avenues for curing once-terminal conditions like cancers and heart disease.

However, the field is far from industrialized — Skilled operators produce these living medicines in small batches using systems sourced from a complex supplier ecosystem.

Scalable manufacturing is part of the solution — MicrofuidX is developing a scalable bioreactor that speeds time to insight and accelerates commercialization.

The nitty-gritty

Cell and gene therapies allow the patient’s body to cure itself with a single dose. “When I first started in this industry,” Dr. Clarke explains, “we didn’t know if these therapies were going to work, then they started working, and then literally in the last five years, we started saying ‘curing.’ To have seen that in my career is incredible for me.”

Researchers are now developing therapies for chronic conditions like epilepsy, rheumatic diseases, and diabetes.

“I think that’s hugely exciting if, from a technology perspective, slightly concerning that there’s really big numbers of patients at the end of these. Do we have the tools that will enable us to get to that scale?”

R&D pipelines translate manual laboratory processes into automated, scalable commercial production. A challenge for chemistry is more complex for cell and gene therapies that depend upon living cells where, as Dr. Clarke points out, small changes can have big impacts.

She contrasts feeding cells in production, where automated incubators maintain perfect conditions, to a lab where a human operator moves a flask to a hood, removes the cap, adds media through a pipette, replaces the cap, and returns the flask. These steps introduce stresses and temperature variations that won’t exist in manufacturing.

“We don’t measure it,” Dr. Clarke says, “We don’t know what impact it really has, but it could be having an impact. So you’re having to go through an optimization phase that is involving large scale technology.”

Data that made the difference:

MicrofluidX balances complexity with simplicity. The company’s core technology is a bioreactor with automation, control, and sensor layers that let this single platform scale from milliliters in the lab to liters in production. Dr. Clarke explains, “It means that you can really start to optimize processes in small volume, understand it, and then drive it to where you need it for manufacturing.”

Listen to the market early. Letting potential customers shape the development path can optimize your product-market fit. “If you’ve already got something that’s ready for the market, it’s too late,” Dr. Clarke says. Qualitative discussions identify issues when you have time to change.

Make engineers talk with people. Asking engineers, whether they want to or not, to join these customer conversations is “really good for them,” Dr. Clarke says. Engineers ask different kinds of questions that directly impact development.