I2 - Cell Therapy Product Engineering, Development and Manufacturing
871: Considerations in Raw Materials when Manufacturing Cell Therapies and Other Biologics
Type: Poster Session
Poster Board Number: 871
Presentation Details
Session Title: Wednesday Posters: Cell Therapy Product Engineering, Development, and Manufacturing
Growth factors are a cornerstone in the intricate landscape of cell therapy manufacturing, playing multifaceted roles essential to produce biologics and other advanced therapeutic medicines. These biomolecules are intricately utilized throughout various manufacturing phases. As growth factors, they stimulate cell reproduction for desired therapeutic compounds as well as differentiate stem cells into cells of interest. After the initial adoption of several cell therapies, focus has become on ensuring manufacturing consistency, quality, and reliability in biopharmaceutical manufacturing. As such, quality control of cell therapies requires a multi-faceted approach for QC of not only the final therapeutic, but also raw materials that go into manufacturing cell therapies. Herein, we explore the different key methods and new assay validation procedures behind GMP product development to ensure a safe raw material for use in therapeutic manufacturing. We also highlight key facets of growth factor ‘grades’ that are associated with different stages of cell therapy manufacturing. As the biopharmaceutical industry continues to evolve and innovate, cell therapy manufacturers need to further emphasize the need for suppliers to ensure these tools are high-quality and provided at the required structure to continue to provide the foundational elements in pursuing improved global healthcare outcomes.
Plain Language Summary
We delve into the crucial role of growth factors in cell therapy manufacturing. These essential biomolecules play a multifaceted role, stimulating cell reproduction and guiding stem cells to differentiate into specific therapeutic compounds. As the focus shifts from initial cell therapy adoption to ensuring manufacturing consistency and reliability, quality control becomes paramount. We explore a comprehensive approach to quality control, covering not only the final therapeutic product but also the raw materials used in manufacturing. It delves into the methods and assay validation procedures essential for developing Good Manufacturing Practice (GMP) products, ensuring the safety of raw materials for therapeutic manufacturing. Emphasizing the significance of growth factor 'grades' at different manufacturing stages, the present study underscores the need for high-quality tools to advance global healthcare outcomes in an evolving biopharmaceutical industry.
Rebecca Warfield1, Spencer Chiang2, Yanke Liu2, Jane Liu2
1ACROBiosystems, Newark, DE,2ACROBiosystems, Beijing, China"
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