Papers and Presentations
How to Search for Resources
You can search for a variety of content on the CASSS website. CASSS makes available any content with author approval. Narrow your search by using the various filters shown below, such as Resource Type, Event Type, and Year. Refine your search as needed.
Refine Results
Filter By Resource Type
Filter By Event Types
- WCBP (461)
- Cell & Gene Therapy Products (230)
- CE Pharm (187)
- Mass Spectrometry (173)
- CMC Strategy Forum Europe (157)
- Bioassays (134)
- Higher Order Structure (109)
- AT Europe (109)
- CMC Strategy Forum Japan (105)
- CMC Strategy Forum (78)
- CMC Strategy Forum North America Winter (77)
- CMC Strategy Forum North America Summer (61)
- CMC Strategy Forum Latin America (40)
- CGTP Summit (37)
- CMC Strategy Forum China (29)
- Consultants' Network (15)
- CMC Strategy Forum North America Fall (14)
- CGTP Europe (11)
- Symposium on mRNA (11)
- Virtual Summit: Bioconjugates (9)
- Virtual Summit: Manufacturing (8)
- Biophysics Working Group (8)
- Virtual Europe Discussion Group (8)
- CGTP Virtual Summit (7)
- NorCal Regional Forum (6)
- Netherlands Area Biotech Discussion Group (5)
- DC Area Scientific Discussion Group (4)
- Biotech Working Group (2)
- Midwest Regional Forum (2)
- CMC-Vaccines Working Group (1)
Filter By Tags
-
Pivoting to Platform: A Case Study in Leveraging Reliance to Enable Fast Implementation of Platform Method for Commercial Products
Speaker Presentation: WCBP 2026 Wu Christine, Genentech, a Member of the Roche Group, 2026 -
Collaborative CMC Assessment of Post-Approval Change Management Protocols: A Regulatory Health Authority-Perspective
Speaker Presentation: WCBP 2026 Wilson Willie, CDER, FDA, 2026 -
Introduction to Session - AI in Development and Manufacturing – New Era in Well Characterized Biologics
Speaker Presentation: WCBP 2026 Thurau Gert, F. Hoffmann-La Roche Ltd., 2026 -
Predictive Stability for
Biopharmaceuticals & Vaccines:
Accelerating Patient Access through Industry
Recommendations and Stakeholder Alignment
Speaker Presentation: WCBP 2026 Skomski Daniel, Merck & Co., Inc., Ji Andrea, Genentech, a Member … -
Keynote Speaker - Michael Sheahan, Danforth, Health, Inc.
Speaker Presentation: WCBP 2026 Sheahan Michael, Danforth Health, Inc., 2026 -
Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Droplets in Biopharmaceutical Products
Speaker Presentation: WCBP 2026 Saggu Miguel, Genentech, a Member of the Roche Group, 2026 -
ICH Q1 Guideline Revisions: Risk Frameworks and Regulatory Readiness
Speaker Presentation: WCBP 2026 Russell Paula, Health Canada, 2026 -
Designing the AI-Enabled CMC Ecosystem for Drug Development and Manufacturing
Speaker Presentation: WCBP 2026 Rolandi Pablo, Amgen Inc., 2026 -
SAHPRA Support for Local GMP Manufacturing and Quality Testing
Speaker Presentation: WCBP 2026 Ratlabyana Mphako, South African Health Products Regulatory Authority … -
What’s New in the World of Stability Testing?
Updates on ICH Q1/Q5C Revisions
Speaker Presentation: WCBP 2026 Rao Ashutosh, CDER, FDA, 2026 -
ICH M16 - Transitioning to Structured Product Quality Submissions
Speaker Presentation: WCBP 2026 Palacios Rodrigo, F. Hoffmann-La Roche Ltd., 2026 -
Enabling Global Pharmaceutical Innovation
Speaker Presentation: WCBP 2026 Nosal Roger, Vaxcyte, Inc., 2026 -
Enabling the Future of Biopharmaceutical Manufacturing Through Collaborative Innovation
Speaker Presentation: WCBP 2026 Myers Riley, NIIMBL, 2026 -
Overcoming Barriers to local GMP
Manufacturing and testing in LMICs:
Doing Things we never had
Speaker Presentation: WCBP 2026 Makhoana Morena, Biovac, 2026 -
Use of Predictive Stability for Shelf-Life Extension, ICH Q1 Annex 2
Speaker Presentation: WCBP 2026 Lemieux Linda, Merck & Co., Inc., 2026 -
Visible Particle Control in Biologics and Advanced Therapy Products: Challenges, Case Studies, and Evolving Expectations
Speaker Presentation: WCBP 2026 Koulov Atanas, Clear Solutions Laboratories AG, 2026 -
Integrating Artificial Intelligence into Pharmaceutical Manufacturing
Speaker Presentation: WCBP 2026 Kiang Tina, CDER, FDA, 2026 -
Controlling Particulate Matter in Ophthalmic Biologics; Establishing a Risk-Based Analytical Approach to Sub-Visible Particulates
Speaker Presentation: WCBP 2026 Jones Lauren C, Regeneron Pharmaceuticals Inc., 2026 -
Building a Resilient Commercial Supply Chain for Antibody-Drug Conjugate Products: A Risk-Based Comparability Approach
Speaker Presentation: WCBP 2026 Jagani Dipkumar, Astellas Pharma US, Inc., 2026 -
No AI Without
Architecture: FHIR
as the Data
Foundation
Speaker Presentation: WCBP 2026 Hyttel Kåre, NNIT A/S, 2026