What insurance does cell and gene therapy manufacturing need?

Manufacturing a cell or gene therapy is not like making a small molecule or even a standard biologic. Viral-vector production and cell processing are highly contamination-sensitive, and a contaminated or out-of-specification batch often cannot be cleaned and shipped - it has to be destroyed and the process re-validated. For autologous therapies, the product is made from an individual patient's own cells, so a lost or compromised batch cannot simply be remade, and the patient may be unable to be treated. That makes a manufacturing loss simultaneously a property, a business-interruption, and a potential liability event.

Beyond ordinary property coverage for the facility and equipment, a CGT manufacturer needs coverage for the cost to re-validate equipment and reprocess or destroy product after a covered loss, because a CGT process cannot resume until it is re-validated. Cryogenic storage systems add a specific exposure: a freezer or liquid-nitrogen failure can destroy an irreplaceable cell bank or patient-specific product, so property and equipment-breakdown coverage should be scoped to that risk.

CGT products move under cryogenic cold chain, and a temperature excursion in transit can destroy the product. Cargo and cold-chain coverage is written to the value and fragility of the shipment. Autologous therapies also carry chain-of-identity and chain-of-custody requirements - the product must be tracked to the correct patient throughout - and a chain-of-identity failure is both a regulatory and a liability exposure. These process risks inform the products and professional liability scope.

CGT manufacturing carries products and completed-operations liability for the finished therapy and, where the manufacturer provides a service (contract manufacturing, patient-specific processing, or administration support), professional liability and errors and omissions. A contract manufacturer will also face sponsor-agreement insurance requirements similar to a CDMO, including additional-insured for products and completed operations. Because the science and the cGMP expectations are specialized, the program is placed through specialty life-sciences markets rather than a generic manufacturing carrier.