The new generation of complex biologics means drug manufacturers can no longer apply a standardized approach to development and manufacturing, such as with monoclonal antibodies. 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.
This webinar will focus on the critical CMC elements of a product’s life cycle and how Lonza Biologics applies its knowledge and experience to provide the regulatory submissions support and strategy necessary for a successful BLA application. You can also learn how Lonza tailors and shortens a development timeline should a product be approved for one of the FDA’s expedited pathways to market.
- The regulatory experience and track record necessary for successful CMC
- How to plan the CMC activities for a license application
- Ways to tailor and shorten the development timeline for an expedited approval pathway