By Lee Allen, Head of Purification Development, and Megan Mason, Head of Cell Culture Development, Lonza
Historically, the biopharma industry has centered much of its focus on the development of monoclonal antibodies (mAbs) and for good reason. They are relatively simple to express in mammalian cell lines and to purify. And while early manufacturing methods were costly and inefficient, improvements in productivity, robustness, and scalability of mAbs have led to unparalleled levels of clinical and commercial success. However, in today’s crowded market, drug developers must diversify their choice of therapeutic molecules to maintain their competitive edge. This has resulted in a shift toward targeted patient populations and unmet needs that is driving a new generation of complex biologics.
With this new landscape of drug products, though, comes new challenges. Specifically, 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.