CASSS Sharing Science Solutions Bioassays 2026

CASSS Bioassays 2026 examines how scientists develop, validate and maintain potency assays for complex biopharmaceutical products. The program links practical challenges in cell-based and relative potency testing with reagent control, method transfer, regulatory strategy and data analysis. Vaccine assays, antibody-drug conjugates and emerging assay technologies provide examples of how these issues differ across therapeutic modalities. Held in Gaithersburg, Maryland, the meeting comprised an April 27 pre-conference short course and an April 28–29 symposium. It is intended for bioassay and analytical scientists, quality-control teams, CMC professionals and regulatory scientists working across the assay lifecycle.

Learning Objectives

Upon completion of this program, participants should be better able to:

• Design and implement robust cell-based and late-stage relative potency assays tailored for commercial projects.
• Navigate the technical and regulatory challenges of developing potency assays for complex, high-valency vaccines.
• Apply recent regulatory guidance by understanding practical considerations for the implementation of updated ICH Q14, ICH Q2, and USP standards.
• Manage variability and navigate critical reagent challenges in cell-based potency assays using statistical frameworks and lifecycle control.
• Evaluate CMC regulatory considerations and analytical comparability strategies for complex modalities, including Antibody-Drug Conjugates (ADCs).
• Explore emerging technologies, including in vitro alternative assays and the application of Artificial Intelligence (AI) in bioassays.

Topics

The original product contents are listed below, in their supplied order. Some supplied titles are shortened. This list does not establish coverage of the full meeting agenda or the pre-conference short course.

• Advancing Drug Development Utilizing T-cell Activation Reporter Gene Assays for Potency Monitoring from the Pre-Clinical to the Commercial S

• CASSS Welcome and Introductory Comments

• Challenges and Strategies for Potency Assay Development in High-Valency Vaccines

• Closing Remarks and Invitation to Bioassays 2027

• CMC Regulatory Considerations for Antibody-Drug Conjugates ADCs From the Biologics Perspective

• In Vitro Alternative Assays to Cell-Based Potency Assays Regulatory Considerations for Biologics

• Joint Keynote Presentation – Hindsight is 2020 50 Years of Combined Bioassay Experiences

• Lunch and Learn Designing Robust Cell-Based Potency Assays Strategic Frameworks and Emerging Biological Readouts Presented by Catalent Pharm

• Lunch and Learn Vendor Showcase

• Managing Variability in Cell-Based Potency Assays Science Statistics and Lifecycle Control

• Navigating Critical Reagent Challenges in Cell-Based Potency Assays Case Studies on Variability and Solutions

• Nutty About Potency Bolting Down a Robust Late-Stage Relative Potency Assay

• Potency Assay Generated Data – Is It a Minefield or a Knowledge Bank and Are They Useable

• Roundtable Session 1 – Table 1 – Method Comparability Considerations

• Roundtable Session 1 – Table 2 – Platform Methods- Practical Considerations for the Implementation of Updated ICH Q14, ICH Q2, and USP

• Roundtable Session 1 – Table 3 – Learnings from Bioassay Transfers

• Roundtable Session 1 – Table 5 – Brainstorming on Applications of AI for Bioassays

• Roundtable Session 2 – Table 1 – Method Comparability Considerations

• Roundtable Session 2 – Table 2 – Platform Methods- Practical Considerations for the Implementation of Updated ICH Q14, ICH Q2, and USP

• Roundtable Session 2 – Table 3 – Learnings from Bioassay Transfers

• Roundtable Session 2 – Table 4 – Product Characterization and Role of Your Potency Assays

• Roundtable Session 2 – Table 5 – Brainstorming on Applications of AI for Bioassays

• Roundtable Session 2 – Table 6 – How Can We Enable Career Development for Young Scientists

• Session I, II, III, IV, and V Panel Discussions

Additional Scheduled Sessions

The source description also names these sessions in the meeting agenda; their inclusion as store files is not confirmed.

• Short Course Part I – Introduction to Bioassay Development: CMC Strategy and Practical Application
• Short Course Part II – Practical Applications for Method Design and Performance
• Better Lifecycle Quality—Powered by Reagent Management
• PlugandPlay Potency: Platform Binding Assay Strategies for Rapid Method Development
• Advancing Cell-Based Potency Assays: Strategies and Challenges in Developing a Robust Functional Assay for Monoclonal Antibody
• ADC Potency Strategy and Structure-Function Studies
• Developing a Potency Strategy for a Novel Antibody-drug Conjugate
• Considerations and Analytical Control Strategies for Half-life Extension of Biotherapeutics
• Potency Assay Data Engineering
• Investigating the Source of Non-Parallelism in Forced Degraded Antibody-RNA Conjugates

Presenters Named in the Program

• Erika Farmer, AstraZeneca
• Yukina Umemoto, Chugai Pharmaceutical
• Sarah Owen, Pfizer
• Arkadi Manukyan, Sanofi
• Catalent Pharma Solutions
• Milica Grozdanovic, Merck & Co.
• Felix Feng, AstraZeneca
• Ravish Patel, Nirma University
• Ganesh Shankarling, Bristol Myers Squibb
• Swayam Prabha, Genentech / Roche
• Lei Zhang, CDER, FDA
• Nailing Zhang, FDA CDER
• Bhoomi Patel, BioAgilytix Labs
• Zhijie (Jey) Cheng, Merck & Co.
• Jan Amstrup, Novo Nordisk
• Ryan Spooner, Amgen
• Alexa Mealy, Eli Lilly and Company

The original meeting venue was the Gaithersburg Marriott Washingtonian Center. Provider registration, live attendance, streaming-platform access, memberships, apps, accounts and publisher-hosted extras are not included unless explicitly listed as store files.