BIO 2025: Fit-for-Purpose Manufacturing for Personalized Therapy
In this BIO 2025 preview interview, The Pharma Navigator chats with Luc Henry from Limula, to discuss the complexities associated with the development and manufacture of personalized therapies and the approaches that are helping companies overcome these challenges.
Personalized therapies, such as chimeric antigen receptor T-cell (CAR T-cell) therapies, are innovative treatments that are offering new hope to patients who have difficult-to-treat illnesses. However, these therapies are also much more complex than traditional pharmaceutical products, making their development and manufacture more challenging.
Swiss company, Limula, was founded on the premise of addressing the hurdles facing the manufacture of cell and gene therapies, notes Luc Henry, DPhil, the company’s CEO. CAR T-cell manufacturing, and most ex vivo cell therapies, require complex processes; however, the bio/pharma industry has “never really had fit-for-purpose tools, because [the therapies] are so new, so innovative,” he remarks.
“Over the past five to 10 years, industry has been trying to look for solutions to address the problems of manufacturability, scalability, and quality control,” Henry says. “We’re now at a point where there are new tools coming to market, people are starting to build and sell fit-for-purpose technologies, and so, it’s just a matter of time for the industry to actually adopt these new tools.”
Other unique challenges for personalized therapies include ensuring sterility throughout the entire process because the end product, a live cell, cannot be sterilized, Henry emphasizes. “Looking at the challenge of sterility with personalized therapies, new tools for development and manufacture need to be much more gentle than they used to be,” he specifies. “[The tools] have to take care of the cells, making sure the cells are perfectly happy and comfortable across every unit operation, while also maintaining sterility.” Additionally, Henry continues, personalized therapies tend to be produced in much smaller volumes than other biologics, meaning that technology had to be reinvented to deal with small volumes — as low as 2 mL.
“[Limula’s] unique selling proposition is in encapsulating the complexity of an end-to-end process in a single instrument,” Henry says. “This is something we could achieve because we made an invention where, for the first time, we combined the functionality of the bioreactor, which is what you need to incubate the cells ex vivo during the process, with the functionality of the centrifuge. And, so, we suddenly have this ability to process cells at the same time as we can incubate them without having to transfer them between a bioreactor and a centrifuge between different unit operations.”
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