Resources
-
Perspectives on Higher Order Structure Characterization From the Biopharmaceutical Industry
Case Study Weiss et al. 2015
-
Specific Binding of a Nonionic Detergent Perturbs Higher Order Structure of a Therapeutic Monoclonal Antibody
Case Study Budyak Doyle Weiss 2014
-
Physicochemical In-use Studies: Industry Experts Insights
Speaker Presentation de Jong Genentech Liu Seagen 2022
-
Bringing MAM to the Next Level: Thermo Scientific MAM 2.0
Speaker Presentation Yang Hao Thermo Fisher Scientific 2022
-
Regulatory Reliance – a Future Reality for CMC?
Speaker Presentation Wilkinson Diane AstraZeneca 2022
-
mAbs to Empowered Antibodies -Strategies beyond IgG
Speaker Presentation Shapiro Marjorie CDER 2022
-
Project ORBIS: Opportunities and Challenges
from the CMC Review of Biologics at Health
Canada
Speaker Presentation Rowlandson Karen Health Canada 2022
-
Mass Spectrometry Enables More Definitive Process & Product Development Towards Well-Characterized Biotherapeutics:
A Personal Account
Speaker Presentation Rouse Jason Pfizer Inc. 2022
-
What’s in a KASA?
Knowledge-Aided Assessment and Structured Application
(KASA) For Biological Products
Speaker Presentation Roelofs Brian CDER, FDA 2022
-
The QC Response to COVID Disruption: A Case Study
Speaker Presentation Nunnally Brian Seqirus 2022
-
HTS and the Future of Vaccine Analytics
Speaker Presentation Ng Siemon Sanofi Pasteur 2022
-
Opportunities and Challenges for Decentralized Manufacturing
Speaker Presentation Moore Christine ORGANON 2022
-
Comprehensive Characterization of a Bispecific T-cell Redirector with Multiple Technologies, CE, iCIEF-MS and Novel Alternative Fragmentation
Speaker Presentation Mahan Nields Janssen 2022
-
Pioneering Disruptive Changes to the Manufacture of Biologics
Speaker Presentation Luu Minh Genentech 2022
-
Mini case study – Leveraging Analytical Prior Knowledge
Speaker Presentation McKenzie Kristi GlaxoSmithKline 2022
-
Translating Innovation in Pharmaceutical Manufacturing and Technologies for the Benefit of Patients – an EU Perspective
Speaker Presentation Jekerle Veronika European Medicines Agency 2022
-
Inspections and Regulatory Harmonization Alternative Tools from a Regulatory Perspective
Speaker Presentation Turcovski Susan FDA Dharmassena Madu CDER FDA 2022
-
Developing Vaccines at
Pandemic Speed
Speaker Presentation Hunsberger Kay Merck 2022
-
Pandemic’s Impact for Supply Chain:
Regulatory Approaches to Manage Supply
Chain Challenges for Single-Use Systems
Speaker Presentation Hughes Patricia CDER FDA 2022
-
Analytical Tools for Characterizing Therapeutic Products
Speaker Presentation Heacock Wayne Agilent Technologies 2022