Successful Manufacturing Of Dry Powder Media From Development To Large-Scale cGMP Production

This study presents a two-phase scale-up strategy for complex dry powder medium (DPM) projects. Phase one involves transferring customer formulations to Gibco™ Rapid Prototyping Services (GRP) for initial non-cGMP scale production. Phase two entails a technology transfer and scaling up production to test larger-scale lots using cGMP Media Manufacturing Services. The strategy proved successful, showing acceptable equivalency from small-sale to larger-scale productions, underpinned by detailed batch records, identical equipment use, robust quality control systems, and site-to-site manufacturing comparability.