Activities for successful Process Characterisation & Process Validation
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.
Regulatory agencies also require additional information on the capability of the process to retain acceptable microbiological qualities, maintain product quality over multiple chromatography cycles etc and approaches for these and other studies will be explained.
This webinar will allow participants to gain insight into how process development studies can be leveraged into a successful process validation.
Presented by
Dr Graham McCreath,
Head of Process Design
Graham is responsible for late stage development, process validation and Quality by Design. He has 18 years experience in industrial bioprocess development gained at PPL, Avecia, MSD and Fujifilm. He has developed and supported a number of products throughout all stages of pharmaceutical development to launched commercial product. He holds a PhD in Chemical Engineering from University of Cambridge.
Dr Mahesh Shivhare,
Senior Process Statistician
Mahesh oversees and provides statistical support to all phases of biopharmaceutical drug development from early phase process development to process and product characterisation, validation as well as commercial manufacturing. He has held similar positions previously with Avecia, MSD and Pfizer and holds a PhD in Chemical Engineering from Newcastle University.
Dr Simon Hanslip,
Senior Technical Project Leader
Simon is a Senior Technical Project Leader in the Process Design group at Fujifilm where he is responsible for directing projects entering late stage development and process validation. Simon has been with Fujifilm Diosynth Biotechnologies for 8 years and was the drug substance technical lead for the Jetrea™ approval. He holds a PhD in Chemical Engineering from University of Cambridge.
