Papers and Presentations
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Bringing MAM to the Next Level: Thermo Scientific MAM 2.0
Speaker Presentation Yang Hao Thermo Fisher Scientific 2022
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Regulatory Reliance – a Future Reality for CMC?
Speaker Presentation Wilkinson Diane AstraZeneca 2022
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mAbs to Empowered Antibodies -Strategies beyond IgG
Speaker Presentation Shapiro Marjorie CDER 2022
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Project ORBIS: Opportunities and Challenges
from the CMC Review of Biologics at Health
Canada
Speaker Presentation Rowlandson Karen Health Canada 2022
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Mass Spectrometry Enables More Definitive Process & Product Development Towards Well-Characterized Biotherapeutics:
A Personal Account
Speaker Presentation Rouse Jason Pfizer Inc. 2022
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What’s in a KASA?
Knowledge-Aided Assessment and Structured Application
(KASA) For Biological Products
Speaker Presentation Roelofs Brian CDER, FDA 2022
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The QC Response to COVID Disruption: A Case Study
Speaker Presentation Nunnally Brian Seqirus 2022
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HTS and the Future of Vaccine Analytics
Speaker Presentation Ng Siemon Sanofi Pasteur 2022
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Opportunities and Challenges for Decentralized Manufacturing
Speaker Presentation Moore Christine ORGANON 2022
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Comprehensive Characterization of a Bispecific T-cell Redirector with Multiple Technologies, CE, iCIEF-MS and Novel Alternative Fragmentation
Speaker Presentation Mahan Nields Janssen 2022
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Pioneering Disruptive Changes to the Manufacture of Biologics
Speaker Presentation Luu Minh Genentech 2022
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Mini case study – Leveraging Analytical Prior Knowledge
Speaker Presentation McKenzie Kristi GlaxoSmithKline 2022
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Translating Innovation in Pharmaceutical Manufacturing and Technologies for the Benefit of Patients – an EU Perspective
Speaker Presentation Jekerle Veronika European Medicines Agency 2022
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Inspections and Regulatory Harmonization Alternative Tools from a Regulatory Perspective
Speaker Presentation Turcovski Susan FDA Dharmassena Madu CDER FDA 2022
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Developing Vaccines at
Pandemic Speed
Speaker Presentation Hunsberger Kay Merck 2022
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Pandemic’s Impact for Supply Chain:
Regulatory Approaches to Manage Supply
Chain Challenges for Single-Use Systems
Speaker Presentation Hughes Patricia CDER FDA 2022
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Analytical Tools for Characterizing Therapeutic Products
Speaker Presentation Heacock Wayne Agilent Technologies 2022
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Quality by Design for Biotechnology Products: An FDA Perspective
Speaker Presentation Graham Laurie CDER FDA 2022
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SLIM Based High-Resolution Ion Mobility for Large Biomolecule Characterization
Speaker Presentation Doherty Tom MOBILion Systems Inc 2022
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N-GLYcanyzer: PAT Toolkit for Near
Real-Time Monitoring of Monoclonal Antibody (mAb) N-Glycosylation
Speaker Presentation Chundawat Shishir Agilent Technologies 2022
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For 2021 meetings, content will be available for one year after the program. For 2022 and beyond, content will be available for three months.