As the biopharmaceutical landscape evolves, the development and production of advanced biologics, including multi-specific immuno-cytokines, antibody-drug conjugates, and high-concentration subcutaneous formulations, present unique and intricate challenges. This series of presentations offers a comprehensive exploration of strategies and best practices for overcoming these complexities.
We will delve into the intricacies of CMC development for complex molecules, with a focus on optimizing production utilizing technology such as transposon and ensuring product purity. Expert insights will be shared on the strategies for comparability studies, highlighting essential practices for maintaining quality and reliability throughout the lifecycle of biosimilars. Considerations for the manufacture and control of antibody-drug conjugates will be discussed, addressing the specialized CMC requirements for these sophisticated therapies.
Additionally, key challenges and considerations in biologics process development and characterization will be examined, offering practical guidance for navigating the development process. Finally, the presentation will cover the formulation and process development of high-concentration subcutaneous biologics, providing solutions to common issues such as viscosity, aggregation, and particle formation.
This series aims to equip attendees with a robust understanding of the current state-of-the-art practices and innovative approaches necessary for the successful development and commercialization of advanced biologics.
Day 1: Mastering Complexity: Strategies for CMC Development and Optimization in the Production of Multi-Specific Immuno-Cytokines
Day 2: Navigating Change: Expert Insights and Best Practices for Ensuring Quality and Consistency in Biologics Comparability Studies
Day 3: Manufacture to Control: Considerations in CMC for Antibody-Drug Conjugates
Day 4: Navigating Challenges in Biologics Process Development and Characterization
Day 5: Formulation and process development for high-concentration subcutaneous biologics drug product