De-Risk Your Drug Development: CMC Manufacturing

This brochure introduces the potential for problems at BLA submission where a recent analysis of FDA complete response letters showed that 47% of the products that received them had CMC analytical issues. In many cases the drug had shown sufficient evidence of clinical efficacy but was delayed entering the market due to issues with the CMC package. An alternative to moving analytical methods as the process moves to new facilities is to use a central analytical laboratory to provide all of the characterization, method development, method validation and quality control activities required throughout the process. Since analytical methods underpin all of the activities in CMC, this will save time, money and ameliorate future regulatory issues.