Expediting Biologics Drug Development: Downstream Strategies To Accelerate Preclinical Development Timelines

In the pursuit of expedited drug development, a variety of molecules including bispecific antibodies, antibody fragments, and fusion proteins are being developed on accelerated timelines for IND applications. This urgent need highlights the critical requirement for rapid and reliable process development methodologies tailored to meet current demands. Leveraging historical knowledge of downstream process development, comprehensive analysis for molecule characteristics using the in silico approach is conducted, facilitating comparisons with previous products to guide process flow.

Furthermore, in striving to expedite timelines, meticulous focus is directed towards implementing several strategies that streamline technology transfer processes and enhance raw material management protocols in the downstream process development stage. These measures are crucial in mitigating risks associated with expedited timelines. In this webinar, Samsung Biologics will discuss how they address these challenges, presenting successful case studies to demonstrate how expedited timelines can be achieved.

Key Learning Objectives:

• Exploring the utilization of historical data in the downstream process to expedite rapid process development
• Implementing effective strategies to shorten the timeline in technology transfer processes
• Analyzing case studies demonstrating the successful application of bispecific antibodies as demonstrated in real-world scenarios

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