Resources
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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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Regulatory Approaches to Accelerated Development of SARS-CoV Neutralizing Antibodies and Vaccines
Speaker Presentation Cho Gutierrez Lugo CBER CDER FDA 2022
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Protein Nanoparticle Vaccines –
A Platform Enabling Rapid Translation from Design to Clinic
Speaker Presentation Carter Lauren University of Washington 2022
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Recombinant Factor C: An Approved and Sustainable Bacterial Endotoxins Test
Speaker Presentation Bolden Jay Eli Lilly and Company 2022
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From Anton to Omicron and Beyond: Towards an mRNA Vaccines Platform
Speaker Presentation Blaschke Ulrich BioNTech 2022