CASSS Sharing Science Solutions Bioassays 2026

Description

+ Include:  videos + file sub vtt +  pdf, size:  GB

+ Target Audience: Immunologists, Pharmacologists, Oncologists, Infectious Disease Specialists

+ Sample video: contact me for sample video

+ Information:

The CASSS Bioassays Symposium 2026 is a premier industry forum scheduled for April 27–29, 2026, in Gaithersburg, Maryland. The event brings together scientific and regulatory experts to discuss current perspectives, technological advancements, and strategies shaping the field of bioassays. The multi-day program features scientific presentations, panel discussions, and roundtables designed to foster collaborative dialogue around analytical approaches and regulatory expectations for complex biopharmaceutical therapies.

Learning Objectives

• 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.

Target Audience

• This symposium provides a collaborative environment for researchers, regulators, and industry professionals to explore the evolving role of bioassays in supporting biopharmaceutical development.
• Best for Immunologists, Pharmacologists, Oncologists, and Infectious Disease Specialists.

Topics

• 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