Accelerating Biosimilar Success: Process Development & Validation Strategies with Cytiva Fast Trak™ - Seguridad Mania.com - España y América Latina

In the upcoming decade, patents for many blockbuster drugs will expire, presenting manufacturers increased opportunities to manufacture biosimilars. However, biosimilar development has its own set of special challenges, including demonstrating high similarity with the reference product, speed of development, and process intensification. In this webinar, we will review case studies that show successful downstream process development (PD) for Fc-fusion proteins and the conversion to single-use platforms for monoclonal antibodies (mAbs) as enabled by the Cytiva Fast Trak™ process development services (PDS) team. We will consider challenges around chemistry, manufacturing, and controls (CMC), processes that are designed to ensure a product meets target quality attributes. Finally, we will review the role of the Cytiva Fast Trak™ validation services team around the criticality of filter selection, understand what testing is required, if manufacturing limits are known, and the use of quality by design (QbD) approach (based on information gained through PD).