A muscle-tissue engineering company is set to highlight the steps being taken to ease the path of regenerative therapies into commercial manufacturing.
Muvon Therapeutics, a clinical-stage company working on regenerative treatments for weakened/damaged muscle and tissue, says key challenges have included co-developing regulations, automation of manufacturing, and hiring experienced personnel.
“There’s a translation gap when you’re bringing a novel therapy from academia into industry,” explains Deana Mohr, PhD, CEO, and co-founder. “Startups need to hit a moving target [on drug regulation] because regulatory frameworks are still maturing.”
One of the early key challenges for Muvon, Mohr says, was finding experienced personnel with the right background to translate a therapy from the laboratory into a GMP-validated process.
“Developing manufacturing protocols takes a couple of years, but this work is often underestimated by people coming from a pure academic and scientific background,” explains Mohr.
Translating a working therapy from the laboratory to patients requires complying with strict drug regulations, she says. Process development also needs to be flexible and agile, as the manufacturing processes for these new therapies are not yet standardized.
“When we started with our clinical trials, most guidelines and documents were based on regulators’ experience with CAR T therapies and, although many things were applicable to other cell-based therapies, many were not,” continues Mohr. “For example, in CAR T, you need to do a killing assay to display potency, but for a regenerative therapy, you can’t use a killing assay because you don’t want to kill the tissue.”
As a result, Muvon and the regulators ended up on a learning curve, Mohr adds. There’s been a growth in flexibility and willingness for regulators to collaborate with startups over the last few years.
This, she says, has been positive for the industry as investors can be hesitant to fund therapies without a clear regulatory pathway. This has led to some early failures of therapies. In addition, she points out, some therapies failed because of the difficulty in adopting automation when the therapy—and its manufacturing process—is so new.
“This was visible to us from the beginning,” notes Mohr. “We are targeting an area of high unmet need, so we knew there was a huge market, and we had to think about scalability from day one.”
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