Late-phase development of biologics remains the lengthiest phase and the most cost-intensive part of drug development. This webinar aims to provide you with an overview of the complex path to a successful product launch, with experts in each of the associated areas weighing in on how their part of the process dovetails into a holistic development strategy.
By Parrish Galliher, independent bioprocess consultant
This real-life story explores a drug product that was in the middle of Phase 3 trials; clinical experts at the FDA were very interested in the outcome. As a result, they examined the commercialization potential of the manufacturing process and found it was inefficient and making an unsafe drug product. They asked us to think about how we would transform the manufacturing process into a licensable process.
Article | By Rupa Pike and Nidhi Sharma,Thermo Fisher Scientific Bioproduction
Understanding not only the limitations of a post-COVID-19 manufacturing landscape, but also developing strategies to help overcome these challenges, is critical to drive the future of next-generation CGTs.
For a small and emerging biopharma, moving into the clinical trial phase of development can be overwhelming, and clinical research organizations (CROs) do not typically manage the comprehensive clinical trial supply chain. Discover seven best practices to help ensure a successful trial.