Abstracts of Presentations

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.
Vertex Pharmaceuticals

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.
Bayer AG

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.
Genzyme Sanofi


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.
Boston University

Presentation 2Status of and Challenges in End-to-end Synthesis of APIs
Klavs Jensen, Ph.D.

Presentation 3Continuous Crystallization in Pharmaceutical Manufacturing 
Allan Myerson, Ph.D.

Presentation 4Innovation 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.
WuXi Biologics

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.
Penn State

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.