Enabling Commercial-Scale Biologics Manufacturing with Media Services

Scale biologics manufacturing from development to GMP production with greater supply confidence. See how integrated media prototyping, stability studies, technology transfer, and commercial GMP supply helped a global CDMO streamline scale-up. Moving from process development to commercial-scale biologics manufacturing can introduce challenges around media qualification, technology transfer, stability, forecasting, and supply reliability. In this case study, discover how Thermo Fisher Scientific collaborated with a global CDMO to create an integrated cell culture media strategy supporting the transition from development through GMP production. The CDMO needed to address several challenges: -Proprietary platform cell culture media required for commercial manufacturing -Lack of validated stability data and confirmed shelf life for GMP media -Frequent small-batch ordering and reactive production planning -Complexity when transitioning from non-GMP development media to GMP manufacturing media -Technology transfer and commercial scale-up risk The integrated approach included: -Gibco Rapid Prototyping Service for non-GMP testing and qualification -Maintaining the same media formulations when transitioning to GMP manufacturing -Comprehensive media stability studies to establish validated shelf-life data -Integration with commercial GMP media supply With validated stability data in place, the CDMO was able to improve forecasting, enable bulk purchasing, and reduce operational complexity. The streamlined development-to-GMP transition also supported scale-up activities while improving supply reliability and manufacturing confidence.