Transitioning from discovery and development to manufacturing - Challenges and opportunities

Presented by Rupa Pike, Strategic Key Accounts Director at Thermo Fisher Scientific The overall success of transitioning the product from development to clinical trials, and ultimately to commercialization, is entirely dependent upon a safe, robust, well-characterized and reproducible process. Scientists can achieve this goal by addressing issues related to raw materials, analytical methods, scalability, personnel training and early incorporation of quality standards. Adopting steps for early process optimization and control will result in manufacturing therapies that meet regulatory requirements and are economically viable at industrial scale.