Recent regulatory initiatives such as Quality by Design and the new FDA guidance on Process Validation have resulted in expectations of greater levels of process understanding from developers and manufacturers of biopharmaceuticals. Often companies when faced with these expectations, are unsure of what is required – what studies should be undertaken and when, what are the best approaches to minimise resources yet to maximise information to support licence applications. In this webinar, Fujifilm Diosynth will present approaches that can be applied to help resolve these issues.
The webinar will begin by highlighting how risk assessment methodologies and their application are essential components of process development strategies. Examples will be given both on the use of risk assessments in the identification of attributes critical to product quality and in identifying important process operating parameters. The application of sound statistical experimental designs and approaches can result in the ability to gain maximum process understanding without excessive resourcing and examples of these approaches will also be discussed.