Continuous Manufacturing for the Modernization of Pharmaceutical Production Proceedings of a Workshop (2019) / Chapter Skim
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Appendix B: Biographies of Planning Committee Members, Speakers, and National Academies of Sciences, Engineering, and Medicine Staff
Appendix B: Biographies of Planning Committee Members, Speakers, and National Academies of Sciences, Engineering, and Medicine Staff
Pages 48-57
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From page 48... ...
biologics at Merck, where she is responsible for providing regulatory leadership, oversight, and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions for biologics. She has more than 15 years of industry experience in CMC development, manufacturing, and regulatory submission of biological products in multiple global pharmaceutical companies.
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From page 49... ...
She was also a key member of the team that developed and implemented innovative technologies for a Manufacturing of the Future initiative with a focus on connected downstream processing, which included developing process control strategies for connected unit operations and devising viral clearance strategies to support validation of connected processes. In her current position, she continues to drive low-cost process development and manufacturing platforms through the assessment of new technologies, plant and equipment design, and process and economic modeling.
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From page 50... ...
His bioprocess expertise includes fed batch and perfusion cell culture process development and scale up, cell culture medium development, bioreactor and facility design, and process control. He currently leads a team of scientists and engineers tasked with the optimization and intensification of a perfusion platform process for the enablement of integrated continuous manufacturing of protein therapeutics.
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From page 51... ...
She has 15 years of downstream process development experience, including 12 years at Amgen as a downstream group leader and Chemistry Manufacturing Controls process team leader for early and late stage antibodies and Fc fusion molecules. She is also a recognized expert in developing viral clearance strategies for monoclonal antibody processes, including understanding key parameters for retroviral clearance by low pH inactivation and various chromatography operations and designing strategies to assess viral clearance of continuous manufacturing processes.
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From page 52... ...
He has been with Amgen since 2002, where his initial focus was on developing purification processes for early and late stage molecules. During this time, he developed and implemented real-time process analytic technologies utilizing light scattering and connected downstream processing.
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From page 53... ...
Fleming Chair Professor, Professor in the School of Chemical and Biomolecular Engineering, Director of the Cornell Institute for Biotechnology, and Director of the New York State Center for Life Science Enterprise. Chris Love is a Professor of Chemical Engineering and a member of the Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology (MIT)
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From page 54... ...
He is currently working on a Japanese Encephalitis virus vaccine, hepatitis B, and the use of lentiviruses for gene therapy, with an interest in upstream and downstream processing and process analytical technology. He received his EngD in Biochemical Engineering from UCL.
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From page 55... ...
She has 20 years of experience in both strategic planning and execution for big pharma and startups in early and late phase process development, manufacturing, regulatory, and pharmacokinetics. Her areas of expertise include early and late phase bioprocess development, integrated continuous biomanufacturing, pharmacology/safety/toxicokinetics, and application of computational models, scale up and scale down of bioprocesses, fill-finish, cgmp, manufacturing technical support, and organizational development.
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From page 56... ...
and is a past recipient of the Excellence in Biological Engineering Publications Award from AIChE. He is the Editor-inChief of the Journal of Membrane Science, and he serves on the Editorial Boards for Separation and Purification Reviews, Separation Science and Technology, Current Opinion in Chemical Engineering, and Biotechnology and Bioengineering.
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From page 57... ...
A natural at building bridges and working across traditional siloes, her work includes Consensus Study Reports and the development of innovative activities and communication approaches to engage a wide breadth of scientists and stakeholders in impactful dialogues related to emerging technologies, environmental health and toxicology, and chemical and biological defense. She received her PhD in Pharmacology from the University of North Carolina at Chapel Hill and her BS in Biochemistry from Clemson University.
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