ISCMP 2016

Kevin Cole, PhD, Lilly
GMP Continuous Drug Substance Production: Ensuring Quality (Abstract; View slides)

Ian Leavesley, BSE Lilly
Enabling a Higher Assurance of Control for Drug Product Manufacturing (Abstract)

Lawrence De Belder, MEng, J&J
Business Case Drivers and Deployment Strategies in the Current Landscape for Continuous Drug Product Manufacturing (Abstract; View slides)

Kelly A. Swinney, PhD, Vertex Pharmaceuticals
Drug Product Continuous Manufacturing: From Business Case to Commercial Manufacturing (Abstract)

Sam Guhan, PhD, Amgen
The Shrinking Footprint: Next Generation Technologies in Biomanufacturing; A Case study in the Application of Continuous Manufacturing (Abstract)

Thomas Daszkowski, PhD, Bayer AG
A New Concept for Biopharmaceutical Production and Resulting Regulatory Challenges (Abstract)

David Pollard, PhD, Merck
Single Use Enabled Automated Continuous Monoclonal Antibody Production with Real Time Release (Abstract)

Veena Warikoo, PhD, Sanofi
End-to-End Continuous Processes Enabling the Implementation of Lean, Flexible and Portable Biomanufacturing (Abstract)

Hannah Robinson, MEng, GSK
The Development of an Integrated Control Strategy for a Continuous Primary Pharmaceutical Process (Abstract; View slides)

Robert Meyer, PhD, Merck
Proof of Operations for Continuous Manufacturing and Real Time Release Testing of Film Coated Tablets (Abstract; View slides)

Mojgan Moshgbar, PhD, Pfizer
Control Strategy for Pharmaceutical Continuous Manufacturing  – Overview and Case Study (Abstract)

Markus Krumme, PhD, Novartis
Considerations on Control Strategies of E2E Pharmaceutical Manufacturing (Abstract; View slides)

Lou Heavner, BSChE, Emerson Process Management
Learnings from Other Industries: “See What Is Possible” (Abstract; View slides)

Aaron Beeler, PhD, Boston University
How Flow Chemistry is Changing Small Molecule Manufacturing by Expanding the Reaction Toolbox (Abstract; View slides)

Klavs Jensen, PhD, MIT
Status of and Challenges in End-to-End Synthesis of APIs (Abstract; View slides)

Allan Myerson, PhD, MIT
Continuous Crystallization in Pharmaceutical Manufacturing (Abstract; View slides)

Salvatore Mascia, PhD, CONTINUUS
Innovation in Continuous Filtration, Drying and Formulation of Drugs (Abstract; View slides)

Philip Shering, Astrazeneca
Commentary on Small Molecule Technologies (View slides)

Massimo Morbidelli, PhD, ETH
End-to-End Integrated Continuous Manufacture of Monoclonal Antibodies (Abstract; View slides)

Weichang Zhou, PhD, WuXi Biologics
Perfusion Cell Cultures as Prerequisites for Integrated Continuous Bioprocessing (Abstract)

Steven Cramer, PhD, RPI
Emerging and Enabling Technologies in Chromatography (Abstract; View slides)

Andrew Zydney, PhD Penn State
Emerging and Enabling Technologies in Membrane Separations (Abstract; View slides)

Rajeev Ram, PhD, MIT
Emerging and Enabling Technologies in Microtechnologies for Bioprocessing (Abstract; View slides)

Richard Braatz, PhD, MIT
Emerging and Enabling Technologies in Control of Continuous Bioprocesses (Abstract; View slides)

Moheb Nasr, PhD
Introduction to Regulatory and Quality Session (View slides)

Markus Krumme, PhD
Regulatory and Quality Considerations, an Industry Perspective (View slides)

Sau (Larry) Lee, PhD
Regulatory and Quality Considerations, a US FDA Perspective (View slides)

Yoshihro Matsuda, PhD
Regulatory and Quality Considerations, a PMDA Perspective (View slides)