A Stepwise Approach To CMC Planning For A Biologics License Application

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.