Regulate with the Times
Ancillary material quality has become critical to the clinical advancement of cell and gene therapies. We need a regulatory framework that ensures safety, while also recognizing the growing cost burden on suppliers
Claudia Zylberberg | | Opinion
How can we manufacture cell and gene therapies in a safe and cost-effective manner to treat as many patients as possible? It’s the key question facing the cell and gene therapy industry right now. Ancillary materials are an increasingly important factor in the cost and safety of these new therapies. Unlike traditional small molecule medicines, cell and gene therapies cannot be sterilized before release. And that means companies must strictly qualify their ancillary materials as part of their effort to ensure patient safety, which comes with a substantial cost burden.
There is often variability among ancillary materials, which complicates efforts aimed at product characterization, specification, and quality management. The variability is largely due to the fact that, traditionally, ancillary materials were used primarily in a research environment, where requirements for material consistency, traceability and reliability are not particularly high. As therapeutic options have matured and moved to the clinic, these materials are now being placed under greater scrutiny by regulators.
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