Application Note: Biologic drug identification at fill and finish

The rapid increase in demand for biopharmaceuticals presents manufacturers with unique challenges to ensure quality and regulatory compliance while maintaining supply and production capacity.

Under GMP guidelines the identity of every container of concentrated commercial drug product and excipient raw material for use in a parenteral drug must be verified, therefore, each incoming bottle of commercial product must be tested in a QC lab before use in fill-finish production. For one pharmaceutical manufacturer and its contract manufacturing organisations (CMOs), this means several thousand bottles per year must be tested for just a single biologic product.

Fill-finish sites may not have the analytical labs with necessary testing equipment and technical resources to perform GMP-required verification testing of protein drug products. Consequently, these sites often ship protein product samples to QC labs for testing causing delays of several days in production and incurring additional costs.