Cell and Gene-Modified Cell Therapies are revolutionizing the future of medicine. As the field continues to rapidly advance, it is paramount that sponsors de-risk manufacturing processes and analytics in development before entering the clinic to mitigate devastating technology transfer and clinical development setbacks. Thus, a scalable and robust framework for new products is critical in order to repeatably and reliably guide cross-functional teams throughout the product lifecycle.
It is important to implement effective commercial readiness risk management strategies right from the early stages of development. Identifying potential risks early on and proactively addressing them ensures a smoother and more efficient progression through the entire process. Implementing a standardized approach incorporating templated documentation that significantly streamlines batch record generation for GMP not only saves valuable time, but also enhances consistency and accuracy. During this webinar, we will discuss Charles River's new product introduction (NPI) framework and how we apply this approach to client programs to streamline the complex journey to the clinic and beyond.