Improved diagnosis is driving precision in treatment, accompanied by increasing regulation stringencies from the likes of the MHRA and FDA. This ensures processes, as well as the products themselves, are fully understood during every step of the manufacturing process. The requirement for both the R&D and manufacturing processes to be ‘data-rich’ has become a prerequisite for drug product manufacturers
and purchasers of drug products alike; a phenomenon driven not only when things go well, but where an irregularity might have occurred, even when confirmed to be within the validated ‘design space’ parameters. Richard Lewis at Biopharma Group explains the growing necessity of R&D to GMP manufacture.