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Scheduling and Optimization of Biomanufacturing Activities in Multi-product Facilities wit...

Megan Rabideau Manufacturing Systems Engineer John Maguire Associate Director of Manufactu...

Single-Use-Systems: Leachable Study Design for Single-Use Components

Kathryn McGohan Scientist I Bristol-Myers Squibb

Current Status of Analytical Techniques for Characterization of Protein Stability

Sanket Patke Research Investigator Drug Product Science and Technology Bristol-Myers Squib...

Current Trends in Control and Monitoring of Subvisible Particulate Matter in Biotherapeuti...

Satish K. Singh Head of Drug Product Process Development Drug Product Services Prof. Dr. H...

Endotoxin Control Strategies for Parenteral Drug Product Manufacturing

Robert Simler Associate Director, Engineering and Technology Biogen, Cambridge, MA, USA Br...

Expanding Adoption of Single-Use Systems Drives Need for Wider Range of Sterile Connector ...

James Barry, Director of Marketing, Americas Pall Biotech

Featured Articles

New Paradigm of Building Quality during Manufacture – Challenges with Biological Products

Rajesh K. Gupta, Ph.D., Principal Consultant
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FDA’s Office of Pharmaceutical Quality Establishes the Center for Excellence in Manufacturing Science and Innovation Research

Kurt Brorson1 and Sau L. Lee2

(1) Office of Biotechnology Products, and (2) Office of Testing and Research, Office of Pharmaceutical quality, Center for Drug Evaluation and Research, US FDA. 10903 New Hampshire Ave., Silver Spring MD 20903. Views expressed in this article constitute the opinions of the authors and not necessarily FDA or US Government policy.

Modernizing Biopharmaceutical Manufacturing: From Batch to Continuous Production

Robert Dream, Managing Director, HDR Company LLC

Single Use Systems in Biologics Manufacturing and their Impact on Manufacturing Execution System (MES)

By: Gloria Gadea-Lopez, Ph.D.
Director of Business Operations Management
John Maguire
Associate Director of Manufacturing Systems

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