Outsourcing Safety and
ell and gene therapies (CGTs) are a class of therapeutic that is fundamentally different from traditional biopharmaceuticals. This is because they involve living cells and this makes them inherently more complex than simple chemical entities or recombinant proteins. Cells interact with their environment in ways that can be difficult to predict and control, so ensuring treatments are safe as well as effective can be a minefield. The cells that form the basis of CGTs must be strictly consistent in terms of their identity, potency and safety. Quality control must be stringent and uncompromising, yet must also be
C
urgency
Cell and gene therapies raise more challenges for quality control than traditional biopharmaceuticals, as they are highly specialised and manufactured in small batches. This is especially true in the case of autologous therapies, where a patient’s own cells are used as the basis for a treatment. Jim Banks speaks to Mike Brewer, director of regulatory at Thermo Fisher Scientifi c and Félix Montero-Julian, healthcare scientifi c director at bioMérieux to fi nd out how companies that produce cell and gene therapies ensure they qualify as safe and effective, while also getting them to patients as quickly as they can.
performed with urgency, as patients needing these therapies do not have time to waste. “Another important point to consider is the fact that CGTs are often produced in small batches, and each batch is unique in that it is related to one patient and is unique in terms of the starting materials,” remarks Félix Montero-Julian, healthcare scientific director at bioMérieux, a leader in the field of in vitro diagnostics. The use of cell therapies comprising modified cells that are given to patients by infusion is growing fast, particularly autologous cell therapy (ACT), in which an individual's cells are cultured
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