What insurance does a viral vector or CGT contract manufacturer need?

A viral-vector producer or cell/gene therapy contract manufacturer needs a manufacturing-focused program on top of the ordinary business lines. Because viral-vector production and cell processing are contamination-sensitive and hard to re-validate, the property program should include the cost to re-validate equipment and reprocess or destroy product after a covered loss - a CGT process cannot resume until it is re-validated.

Cryogenic storage adds equipment-breakdown exposure (a freezer or liquid-nitrogen failure can destroy an irreplaceable cell bank), and shipments move under cryogenic cold chain, so cargo and cold-chain coverage is written to the value and fragility of the product. Products and completed operations liability covers the finished output, and where the manufacturer provides a service - contract manufacturing or patient-specific processing - professional liability and errors and omissions apply.

A CGT contract manufacturer will also face sponsor-agreement insurance requirements similar to a CDMO, including additional-insured for products and completed operations and specified limits. Because the cGMP expectations are specialized, the program is placed through specialty life-sciences markets rather than a generic manufacturing carrier.