Virtual Learning Series Presentations

SMALL MOLECULES

Transforming Pharmaceutical Manufacturing: 21st Century Initiative
Ajaz Hussain (President of The National Institute for Pharmaceutical Technology & Education, USA)
The presentation will cover the importance of understanding Product and Process robustness through effective application of QbD and the vision for the future state for manufacturing and Quality Control laboratories. Dr Hussain will also discuss the history, evolution and impact over the past 16 years – where are we, what’s next and how do we improve.

Continuous Manufacturing: Business Case Drivers, Control and Deployment Strategies for Small Molecule Oral Products
Peter Van Broeck (Scientific Director Small Molecules Pharmaceutical Development, Janssen Pharmaceuticals, Belgium)
This presentation will examine different elements that can drive the business case of a continuous manufacturing project, and which strategies could be used to deploy this wonderful technology throughout an organization. Also covered will be an overview of the analytical control strategy for a continuous process and its impact on the laboratory

The Evolution of PAT for Small Molecules
Martin Warman (UK Medicine Manufacturing Innovation Centre)
Join us on a journey of the introduction and changing use of PAT for development and as part of a real-time release control strategy, whilst covering approaches for interacting with global health authorities around the use of PAT. But also highlighting gaps in the current PAT portfolio and opportunities for further innovation.

Continuous API - What You Need to Know
Malcolm Berry (Chemistry Consulting, UK)
Listen to the thoughts and insights of an API process expert and what you need to know and understand when looking to transform your manufacturing practices from traditional batch to continuous manufacturing.

LARGE MOLECULES

Transforming Biopharmaceutical Manufacturing: 21st Century Initiative
Ajaz Hussain (President of The National Institute for Pharmaceutical Technology & Education, USA)
The presentation will cover the importance of understanding Product and Process robustness through effective application of QbD and the vision for the future state for manufacturing and Quality Control laboratories. Dr Hussain will also discuss the history, evolution and impact over the past 16 years – where are we, what’s next and how do we improve.

Developing and Applying Integrated Continuous Bioprocessing Platform to Biologics Development and GMP Production in a Highly Flexible Modular Manufacturing Facility
Jared Auclair (Director, Northeastern’s Biopharmaceutical Analysis & Training Lab [BATL], USA)
This talk will be an overview of continuous bioprocessing with new supportive single-use technologies for better process control, improved process robustness and reduced operational and capital expenditures driving efficiency, productivity and greater product yields

Automated Multidimensional Separations and Advanced Bioinformatics for the Rapid Analysis and Control of Glycosylation in Bioprocessing
Pauline Rudd (Bioprocessing Technology Institute, A*STAR, Singapore)
A presentation on the current challenges and unmet analytical needs associated with in-line chromatography. Why is it so important to make in-line chromatography successful? An industrial case study will also be outlined