A Stepwise Approach To CMC Planning For A Biologics License Application

By Jason Osman, Senior Director, Head of Proposals, and John McGuire, Global Head of Regulatory Affairs, Lonza Biologics

The complexity and diversity of today’s pipelines are creating new challenges throughout every stage of development, requiring a wide range of expertise to ensure a drug can be produced consistently from batch to batch. While safety, quality, and efficacy are the primary focus during this journey, manufacturers must also consider the regulatory requirements they need to meet in order to bring their drug to market. A critical step in reaching this milestone is designing a chemistry, manufacturing, and controls (CMC) strategy that gives regulators confidence that the development and manufacturing plan outlined for your product is properly tailored to meet its unique characteristics and needs.

As part of the biologics license application (BLA), a CMC strategy that does not meet expectations could add unexpected costs to your bottom line and, even more importantly, create delays that threaten market entry. And with more products qualifying for one of the FDA’s expedited pathway to market, you must be able to accelerate development while also preserving quality throughout the product life cycle. Lonza understands these challenges and has developed a structured and stepwise approach to CMC planning that is tailored to our customers’ product, process, timelines, and risk tolerance. Doing so not only keeps your program on track but also adds value and quality assurance to your end product.