Pharma 4.0 – 2020
Transforming Pharmaceutical Manufacturing
Technology, Innovation & Impact on the Laboratory
Separation Science, in collaboration with Thermo Fisher Scientific, developed a virtual learning series with thought leaders from across the world 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 – 2020 brought together participants from industry, academia and regulatory to create an invaluable opportunity to discuss the recent developments, future trends, challenges and solutions for the development & manufacturing of pharmaceutical & biotechnology products.
Complementing the PHARMA 4.0 – 2020 virtual learning series are three round table Forums, each covering a topic key to this field – Lab of the Future, Emerging Technologies, and Regulatory and Quality Challenges.
SMALL MOLECULES
FDA 21 Century Pharma Quality 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.
Analytical Technology Innovation in Continuous Manufacturing Science for Small Molecule Tablet Granulation Processes and the Impact on the Laboratory Development?
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.
LARGE MOLECULES
FDA 21 Century Pharma Quality 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.
Process Control and Monitoring for Continuous Production of Biopharmaceuticals
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.
FREE learning from the experts!
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