47181 - Innovation for Products and Processes

There are lots of exciting developments and innovations for biopharma products and processes that have the potential to transform healthcare treatment and delivery. Regulators, industry and academia are increasingly working together to help ensure that new products can reach patients more efficiently, via collaborative activities that have been catalyzed by the COVID-19 pandemic.

In some cases, novel technologies or manufacturing flexibilities are challenging the current regulatory paradigm. To address this, in the last year, EMA has announced the intention to form a Quality Innovation Group and held a survey on novel products and processes, MHRA launched a ‘Point-of-care manufacture’ consultation, and FDA has been engaging at conferences on FRAME – their Framework for Regulatory Advanced Manufacturing Evaluation.

At the same time, the MHRA Innovation Office, EMA Innovation Task Force and FDA Emerging Technology Program have been encouraging more early engagement and dealing with higher numbers of queries on more complex products and processes.

In this session, we will explore innovative approaches in manufacturing including decentralized, flexible, mobile, adaptive, 3D printing and end-to-end continuous manufacturing approaches. In addition, we will discuss the regulatory framework needed to support novel manufacturing and hear about the different initiatives under development by the regulatory agencies to support MAs to be submitted in the next 5-10 year period.

Session Speakers:
Support to Innovation by EMA - Facilitating Translation of Technology into Medicinal Products
Robert Bream, EMA - European Medicines Agency, Netherlands

Agile Manufacturing: Transfer and Scale-up of Biologics Aseptic Manufacturing Processes through Control Site Concept
Karoline Bechtold-Peters, Novartis Pharma AG, Switzerland

Continuous Manufacturing in Biologics Adoption and Regulatory Engagement
Ana-Silvia Nita, MSD, Switzerland

Platform Protocol Templates: An Innovative Upcoming Tool for Comparability Assessment and Process Validation
Olga Rovira, CEPI-Coalition for Epidemic Preparedness Innovations, Belgium