Comprehensive pre-work, such as process development and analytical method development, ensures clarity about opportunities and potential pitfalls when going into the GMP batch. This first GMP batch forms the basis for FIH clinical trial material, minimizing manufacturing-related variability and allowing for better comparison of safety and efficacy data.
Slip-ups resulting from a lack of knowledge, experience, or training can lead to delays or even regulator intervention, depending on the severity of the issue. Process development & optimization, raw material sourcing and qualification, quality control & testing, and documentation & batch record-keeping all must be aligned to ensure the GMP batch and, by extension, FIH batch production, is carried out successfully. Moreover, specialized individual and team training, as well as a concerted communication & collaboration campaign, are necessary to create an environment conducive to that success.
By James Schwindeman, Ph.D. LAXAI
