IMPLEMENTING CMC STRATEGIES FOR SCALE-UP OPERATIONS IN BIOLOGICS MANUFACTURING 

Presented Dr Anita Krishnan, Assistant Director, Head, CMC development at Lupin and Dr. Annu Uppal Manager Biopharmaceutical Applications at AB SCIEX
Biotechnological products are so complex, that manufacturing biologics which are both cost-effective and with the best product quality is a technical challenge. In the context of biosimilar manufacturing at each step, the sponsor should evaluate the extent to which there is residual uncertainty about the biosimilarity of the proposed product. Often there is a remnant quality difference beyond the capability of the process to address. In such instances, in-depth understanding of the process, impurities, analytical methods, the mechanism of action (MOA) of the drug substance and clinical relevance of any observed structural differences, will help in implementing novel CMC strategies. This talk will examine the elements of biopharmaceutical development that lead to the successful licensure of biotherapeutics.