From Development to Commercialization: Overcoming Scale-Up Issues
Summary: Following a drug development program’s clinical success, pharmaceutical companies will look toward manufacturing and commercialization strategies for their therapy. However, failing to sufficiently prepare for the scale-up activities needed for commercialization can often delay project timelines, increase costs, and lead to a significant amount of rework. In fact, it is often the case that the consequences of decisions made at this stage will endure throughout the life of the product.
Recorded at Manufacturing Chemist Live 2020, this presentation discusses some of the key issues to consider when planning for the scale-up of a small molecule development program, with a focus on highly potent drugs. Using case studies, Christopher Harrison, Director of Manufacturing Operations, at Catalent’s facility in Nottingham, U.K., examines some of the common pitfalls that have led to ineffective technology transfers, and demonstrates how these can be avoided through the adoption of an integrated approach that takes into account program needs from early-phase development to clinical supply, and on to commercialization.