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Pharma 4.0 - Transforming Pharmaceutical Manufacturing

Separation Science has developed a virtual learning series with thought leaders from across the world meet to discuss and explore current and future trends in QbD and PAT and their impact on the laboratory of the future and its connection to manufacturing.

Separation Science has developed a virtual learning series with thought leaders from across the world meet to discuss and explore current and future trends in QbD and PAT and their impact on the laboratory of the future and its connection to manufacturing. PHARMA 4.0 will bring together participants from industry, academia and regulatory to create an invaluable opportunity to discuss the recent developments, future trends, challenges and solutions for development & manufacturing of pharmaceutical & biotechnology products.

Complementing the PHARMA 4.0 virtual learning series will be three round table Live Forums, each covering a topic key to this field - 'Lab of the Future', 'Emerging Technologies', and 'Regulatory and Quality Challenges'.

A 'Certificate of Attendance' will be provided to all registered attendees to the virtual learning series and live video forums.

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

Transforming Pharmaceutical Manufacturing: 21 st 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 and Deployment Strategies for Small Molecules Oral Solids
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 (Martin Warman Consultancy Ltd and Professor of Practice at University of Strathclyde, UK)
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.


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

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Video Forums
LAB OF THE FUTURE
15 September, 2020 - starting at 12.30pm IST / 3pm SGT / 4pm JST
The new R&D model and the opportunities from game-changing technologies herald a transformation of the laboratory, enabling scientists to deliver the next generation of treatments to patients with speed & efficiency. This Forum will ask key experts questions relating to best practice, successful incorporation of new technologies, collaboration, and innovation. Considering the shift from batch-based manufacture to continuous processing and how the laboratory moves to the line to allow real-time testing. What impact will this have on the development and QC laboratories of the future?

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?

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?

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