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Most approved cell therapies reach the patient frozen — and the whole idea is that the cells must behave exactly the same after thawing as they did before they were frozen.
BioLife Solutions CTO Sean Werner argues that what the supply chain science that comes after manufacturing is the make-or-break step for many cell therapy therapeutics, and too often treated as an afterthought.
- Werner leads product development at BioLife Solutions, a long-running cryopreservation partner whose media keep cells viable as they're shipped around the world; he joined BioLife after the company acquired Sexton Biotechnologies, where he was previously President.
- The autologous-to-allogeneic shift won't remove the cold chain: allogeneic products are faster and can sit closer to the patient, but they'll still need to be cryopreserved, possibly under new temperature paradigms.
- Werner explains BioLife's new ice-recrystallization-inhibition technology that has been designed to tackle a subtle but commonly seen failure in cold chain — ice crystals that reform and grow as frozen cells pass through warmer temperatures, causing all sorts of damage to the cell structure. The technology has the potential to enable the use of much lower levels of cryoprotectant (less dimethyl sulfoxide), and stable storage at −80°C. Even shipping on ice rather than using liquid nitrogen could become a possibility.
- COVID was the field's cold-chain wake-up call: the people who ran large-scale logistics at pandemic scale have now been widely hired to bring that knowledge to cold chain, which Werner relates is a pretty small market in comparison to the big pharma companies these hires came from.
- His warning to developers: storage and distribution are still bolted on late in the planning stage, well after the biology and manufacturing have been set in place — this means programmes lose time that could have been saved if the programme's leadership team had got it right first time.
With thanks to the International Society for Cell & Gene Therapy for welcoming Onyx Live to Dublin.
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