Tiffany D. Rau, PhD, Principal Consultant, Rau Consulting LLC and Christine Gonzales, Senior Product Manager, Thermo Fisher Scientific
The process of bringing a new drug to market requires a multidisciplinary approach. It involves a wide range of expertise in science, engineering, manufacturing, analytics, quality, and supply chain logistics across the entire product life cycle. All stakeholders work together to ensure that a potential new drug is effective and can be produced in an efficient manner, delivering a high-quality and consistent product that meets clinical quality and commercial demands.
Decisions made early in development, and even in discovery, can send the molecules down very different paths, which will cause challenges in multiple ways. Planning early for manufacturability reduces surprises, such as challenges with reproducibility and scale-up, as the molecule goes through the chemistry, manufacturing, and control (CMC) journey and, upon approval, to the patient. Drug development is rewarding, but the number of approvals each year is minimal compared to how many molecules are in development pipelines.
Many critical decisions are made in process development that can minimize obstacles as a drug is transferred and produced in manufacturing. Scaling challenges, timelines, and regulation pitfalls can be diminished when these teams are aligned with each other’s capabilities. Resources, such as capital equipment, can also be conserved. There will always be challenges, but through communication, data, new technologies, and problem-solving, next-generation medications can be delivered safely and in an efficient manner.