Video Forums

EMERGING TECHNOLOGIES IN CONTINUOUS PROCESSING
23 September, 2020 - starting at 12.30pm IST / 3pm SGT / 4pm JST

An opportunity to discuss current technology platforms being used in, for example, small molecule tablet granulation and bioprocessing processes to help identify unmet technology and informatics needs. What technologies need to be integrated, what’s missing and how is it all pulled together through meaningful data visualisation? What do equipment and analytical instrument companies need to do to understand and meet the challenges of continuous small molecule manufacture and continuous bioprocessing?

Expert Panel:

  • Mike Claybourn (Moderator - Altair Innovations)
  • Jared Auclair (BATL, Northeastern University)
  • Peter Van Broeck (Janssen)
  • Pauline Rudd (A*Star, Singapore)
  • Richard Ladd (Laddavis Scientific Consultancy, UK)
  • Saw Yen Ow (CSL Ltd, Australia)
  • Dr Sridevi Khambhampaty (Intas Bio Pharma, India)

REGULATORY & QUALITY CHALLENGES
29 September, 2020 - starting at 12.30pm IST / 3pm SGT / 4pm JST

The discussion will cover such topics as acceptance from regulators on new technology, what steps have been taken by regulators to embrace technological advances to help enable fast adoption and a slicker approval, and what is the process for registering new analytical capabilities and how is this changing?
Where is the Regulatory position today? Worldwide harmonization – where is it and what’s needed? Company regulatory vs governmental regulatory?

Expert Panel:

  • Richard Ladd (Moderator - Laddavis Scientific Consultancy Ltd)
  • Ajaz Hussain (National Institute for Pharmaceutical Technology & Education, USA)
  • Christine Moore (Merck, USA)
  • Yoshihiro Matsuda (PMDA, Japan)
  • Ravi Desai (Lupin, India)
  • Pramod Dalvi (CIPLA, India)
  • Peter Van Broeck (Janssen)

 

Virtual Learning Series Programme - Now Complete

DAY 1: SMALL MOLECULES
8 September, 2020 - starting at 12.30pm IST / 3pm SGT / 4pm JST

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.

 

DAY 2: LARGE MOLECULES
9 September, 2020 - starting at 12.30pm IST / 3pm SGT / 4pm JST

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

The virtual learning series and live forums are run in collaboration with Thermo Fisher Scientific. The event is free to access - to register to attend this series of online talks complete the form right.


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