Case studies and presentations on new technologies from the world leaders of the pharmaceutical companies and academia engaged in continuous manufacturing of small- and bio-molecules will be presented.
Case Study Session 1--Small Molecules
Case Study 1: A Case Study in GMP Continuous Drug Substance Production: Ensuring Quality
Kevin Cole, Ph.D.
Case Study 2: Enabling a Higher Assurance of Control for Drug Product Manufacturing
Ian Leavesley, BSE
Case Study 3: Business Case Drivers and Deployment Strategies in the current Landscape for Continuous Drug Product Manufacturing
Lawrence De Belder, M.Eng
Johnson & Johnson
Case Study 4: Drug Product Continuous Manufacturing: From Business Case to Commercial Manufacturing
Kelly A. Swinney, Ph.D.
Case Study Session 2--Bio-Manufacturing
Case Study 1: The Shrinking Footprint – Next Generation Technologies in Biomanufacturing; A Case study in the Application of Continuous Manufacturing
Sam Guhan, Ph.D.
Case Study 2: A new concept for biopharmaceutical production and resulting regulatory challenges
Thomas Daszkowski, Ph.D.
Case Study 3: Single Use Enabled Automated Continuous Monoclonal Antibody Production with Real Time Release
David Pollard, Ph.D.
Merck & Co.
Case Study 4: End-to-End continuous processes enabling the implementation of lean, flexible and portable biomanufacturing
Veena Warikoo, Ph.D.
Case Study Session 3--Small Molecules
Case Study 1: How Flow Chemistry is Changing Small Molecule Manufacturing by Expanding the Reaction Toolbox
Hannah Robinson, MEng
Case Study 2: Proof of Operations for Continuous Manufacturing and Real Time Release Testing of Film Coated Tablets
Robert Meyer, Ph.D.
Merck & Co.
Case Study 3: Control Strategy for Pharmaceutical Continuous Manufacturing – Overview and Case Study
Mojgan Moshgbar, Ph.D.
Case Study 4: Considerations on Control Strategies of E2E Pharmaceutical Manufacturing
Markus Krumme, Ph.D.
Learning from Other Industries
Presentation: Learnings from Other Industries: See What is Possible
Lou Heavner, BSChE
New Technology Session 1--Small Molecule Technologies
Presentation 1: How Flow Chemistry is Changing Small Molecule Manufacturing by Expanding the Reaction Toolbox
Aaron Beeler, Ph.D.
Presentation 2: Status of and Challenges in End-to-end Synthesis of APIs
Klavs Jensen, Ph.D.
Presentation 3: Continuous Crystallization in Pharmaceutical Manufacturing
Allan Myerson, Ph.D.
Presentation 4: Innovation on Continuous Filtration, Drying and Formulation of Drugs
Salvatore Mascia, Ph.D.
New Technology Session 2--New Bio-Processing Technologies
Presentation 1: End-to-End Integrated Continuous Manufacture of Monoclonal Antibodies
Massimo Morbidelli, Ph.D.
Presentation 2: Perfusion Cell Cultures as Prerequisites for Integrated Continuous Bioprocessing
Weichang Zhou, Ph.D.
Presentation 3: Emerging and Enabling Technologies in Chromatography
Steven Cramer, Ph.D.
Presentation 4: Emerging and Enabling Technologies in Membrane Separations
Andrew Zydney, Ph.D.
Presentation 5: Emerging and Enabling Technologies in Microtechnologies for Bioprocessing
Rajeev Ram, Ph.D.
Presentation 6: Emerging and Enabling Technologies in Control of Continuous Bioprocesses
Richard Braatz, Ph.D.