Drug manufacturers can no longer apply a standardized approach to development and manufacturing, such as with mAbs. Instead, they must use a wide range of disciplines to define a product’s unique characteristics, the strategies for managing them, and the testing that needs to take place to ensure a drug consistently maintains its quality attributes from batch to batch. Regulatory authorities require this information to be outlined in the chemistry, manufacturing, and controls (CMC) section of the biologic drug application (BLA) and investigational new drug application, so they can have confidence a company’s drug production methods align with their requirements and expectations. Therefore, it is important you understand the challenges associated with creating a CMC strategy and the expertise and resources you need to successfully execute it.
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