CASSS Sharing Science Solutions Bioassays 2025

Bioassays • Potency Assays • Biologics • Regulatory Science • Cell & Gene Therapy

April 7–9, 2025 | Gaithersburg, Maryland

Explore contemporary scientific approaches, regulatory strategies, and emerging technologies in bioassay development with CASSS Sharing Science Solutions Bioassays 2025.

Officially titled Bioassays 2025: Scientific Approaches and Regulatory Strategies, the symposium was held April 7–9, 2025, at the Gaithersburg Marriott Washingtonian Center in Gaithersburg, Maryland. The meeting brought together professionals involved in biologics development, analytical science, potency testing, regulatory strategy, and advanced therapeutic modalities.

Organized by CASSS – Sharing Science Solutions, the Bioassays symposium provides an international forum for discussing current perspectives, scientific strategies, technologies, lessons learned, and the development and standardization of methods used for bioassays. The program combines scientific presentations, case studies, panel discussions, roundtables, posters, and interaction with industry thought leaders.

The 2025 scientific program placed particular emphasis on bioassay fundamentals, potency assays, multi-specific antibodies, antibody-drug conjugates (ADCs), Fc-mediated biology, emerging bioassay technologies, artificial intelligence, assay lifecycle management, cell and gene therapy, CAR potency strategies, and AAV infectivity assays.

Course Details

• Program: Bioassays 2025: Scientific Approaches and Regulatory Strategies
• Organization: CASSS – Sharing Science Solutions
• Year: 2025
• Dates: April 7–9, 2025
• Venue: Gaithersburg Marriott Washingtonian Center
• Location: Gaithersburg, Maryland, United States
• Primary Field: Biopharmaceutical Analytical Science
• Primary Focus: Bioassay Development, Potency Assessment, and Regulatory Strategy
• Related Areas: Biologics, Multi-Specific Antibodies, ADCs, Cell & Gene Therapy
• Educational Formats: Workshops, Scientific Sessions, Case Studies, Panel Discussions, Roundtables, Posters
• Primary Audience: Scientists and Professionals Involved in Bioassay Development, Analytical Science, Biologics, and Regulatory Strategy

CASSS reported that Bioassays 2025 drew more than 120 attendees, with discussions spanning potency assays, multispecific antibodies, ADCs, emerging technologies, and related scientific and regulatory challenges.

Who Was the Original Program Designed For?

Bioassays 2025 was designed for professionals involved in the scientific, analytical, quality, and regulatory aspects of bioassays and biologic drug development.

The program is especially relevant for:

• Bioassay Scientists
• Analytical Scientists
• Potency Assay Scientists
• Biopharmaceutical Development Scientists
• Quality Control Scientists
• Regulatory Professionals
• CMC Professionals
• Cell-Based Assay Scientists
• Biologics Researchers
• Cell and Gene Therapy Scientists
• Scientists working with multispecific antibodies
• Scientists working with antibody-drug conjugates

It is also particularly relevant for:

• Immunologists
• Pharmacologists
• Clinical Pathologists
• Oncologists

The strongest scientific audience remains:

Bioassay Development + Biopharmaceutical Analytics + Potency Testing + Regulatory Science

Learning Objectives

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

• Evaluate current perspectives, regulatory strategies, and technologies used in bioassay development.
• Analyze technical and regulatory details through high-quality case studies and scientific discussions.
• Formulate strategies for the development and standardization of methods used for bioassays.
• Implement specific bioassay strategies for multi-specific antibodies and antibody-drug conjugates.
• Assess emerging innovations and the development of new target cell lines to evaluate cytotoxicity.

Bioassay Development

Bioassays are central to evaluating the biological activity and potency of many complex biologic products.

The CASSS program follows bioassays across the development lifecycle:

Mechanism of Action → Assay Design → Method Development → Characterization → Validation → QC → Lifecycle Management

Rather than focusing only on assay execution, the symposium also examines how scientific understanding, product complexity, regulatory expectations, and manufacturing strategy influence the selection and performance of an appropriate bioassay.

Introduction to Bioassay Development

The April 7 pre-conference workshop included:

Introduction to Bioassay Development: CMC Strategy and Practical Application

with instructors from AstraZeneca.

The workshop connected foundational bioassay principles with practical CMC considerations.

Important areas include:

• Assay strategy
• Method design
• Biological relevance
• Product development
• Analytical performance
• Practical implementation

Practical Applications for Method Design & Performance

The second half of the official workshop focused on:

Practical Applications for Method Design and Performance

with instructors from Bristol Myers Squibb.

This connects theoretical bioassay development with the practical challenge of producing methods that perform reliably throughout product development.

The overall framework can be summarized as:

Understand Biology → Select Assay → Design Method → Characterize Performance → Optimize

Bioassay Foundations

The first major scientific session was:

Bioassays Foundations / Nuts and Bolts of Bioassays.

This session included presentations addressing cell-based potency assays, Fc-mediated activity, and potency evaluation strategies.

Cell-Based Potency Assays

One confirmed presentation addressed:

A Novel Cell-Based Potency Assay to Measure Cell/Cell Phagocytosis Induced by Antibody-Dependent Cellular Phagocytosis

presented by Lena Knauber of AbbVie.

This illustrates the role of cell-based methods in assessing biological activity that reflects a therapeutic product’s mechanism of action.

Antibody-Dependent Cellular Phagocytosis

Antibody-Dependent Cellular Phagocytosis – ADCP is one mechanism that may require a functional bioassay capable of reflecting relevant cellular activity.

Bioassay development in this context requires connecting:

Biologic Product → Mechanism of Action → Cellular Response → Quantifiable Potency

Afucosylation & Potency Evaluation

Another confirmed presentation was:

Afucosylation: Potency Evaluation Strategies

presented by Victoria Swiss of Bristol Myers Squibb.

This topic connects glycosylation-related product characteristics with functional potency assessment.

Fc-Mediated Cytotoxicity

The symposium also featured the technical seminar:

Development of a New Class of Target Cell Lines to Evaluate Fc-Mediated Cytotoxicity.

This directly supports the program’s focus on emerging cell systems and improved biological models for cytotoxicity testing.

New Target Cell Lines

Developing suitable target cell lines can improve the biological relevance and performance of cell-based assays.

Relevant considerations include:

• Target expression
• Cellular response
• Reproducibility
• Assay robustness
• Cytotoxicity readout
• Mechanistic relevance

The goal is to create an experimental system capable of reliably reflecting the biological activity being measured.

Multi-Specific Antibodies

One of the defining sessions of Bioassays 2025 was:

Bioassay Strategies for Multi-Specific Antibodies.

Multi-specific molecules can create unique assay-development challenges because more than one target, mechanism, or functional pathway may contribute to product activity.

Bi-Specific Antibodies

The session included:

Navigating the Complexities of Bi-Specifics: Leveraging Bioassays for Product Variant Characterization and Process Development

presented by Yishi Liu of Genentech.

This topic connects bioassay strategy with:

• Product variants
• Molecular complexity
• Process development
• Functional characterization
• Potency assessment

Elranatamab Bioassay Strategy

Another presentation was:

Elranatamab: Bispecific mAb Bioassay Strategy from R&D to Commercialization

presented by Peter Richard of Pfizer.

This provides a real-world example of how a bioassay strategy may need to evolve across:

Research → Development → Manufacturing → Commercialization

Potency Specification Strategy

The multi-specific antibody session also included:

Bridges Over Montgomery County: Revamping the Potency Specification Strategy for a Complex Modality

presented by Dylan Weil of AstraZeneca.

This reinforces the importance of linking assay performance with specification strategy for complex biologics.

Antibody-Drug Conjugates – ADCs

A full scientific session on April 9 focused on:

Antibody Drug Conjugates.

ADCs combine biologic targeting with drug delivery and therefore present unique analytical and potency-assay challenges.

ADC Development & Potency Assay Lifecycle

The session included:

Navigating Complexity: A Strategic Framework for Streamlining and Simplifying Antibody Drug Conjugates Development and Potency Assay Lifecycle Management

presented by Larisa Toulokhonova of Merck.

This connects ADC development with:

• Potency strategy
• Assay design
• Lifecycle management
• Analytical complexity
• Regulatory expectations

Cell-Based Potency Assays for ADCs

Another confirmed presentation was:

Use of High Content Imaging to Enable Cell-Based Potency Assay Development for ADCs

presented by Madhumati Mukherjee of AstraZeneca.

High-content imaging can extend bioassay readouts beyond traditional endpoint measurements and support more detailed evaluation of cellular responses.

Inducible Promoter Systems

The ADC session also featured:

Inducible Promoter Systems: Pioneering the Future of Bioassay Development for Enhanced Precision Control

presented by Nicole Shi of Eli Lilly.

This represents another example of emerging biological tools being applied to improve assay control and performance.

ADC Bystander Killing

The Emerging Professionals session included:

Development of an in Vitro Bystander Killing Bioassay for ADCs

presented by Andrea Parsons of Pfizer.

This topic addresses functional assessment of an important biological effect relevant to some ADC products.

Biotherapeutic Fusion Proteins

The Emerging Professionals session also included:

Potency Control Strategy for Biotherapeutic Fusion Proteins

presented by Long Zheng of Bristol Myers Squibb.

This demonstrates that potency-assay strategy extends beyond conventional monoclonal antibodies to increasingly diverse biologic modalities.

Emerging Technologies & Innovations in Bioassays

Another major session was:

Emerging Technologies / Innovations in Bioassays.

This session explored how newer technologies and assay designs may improve biological relevance, QC testing, and characterization.

MoA-Reflective Bioassays

A confirmed presentation was:

MoA-Reflective Bioassays for Next-Gen QC Testing

presented by Ayumi Takayanagi of Chugai Pharmaceutical.

Mechanism-of-action-reflective assays aim to ensure that QC testing remains biologically meaningful rather than simply analytically convenient.

Next-Generation QC Testing

A central challenge in biologics quality control is achieving an appropriate balance between:

• Biological relevance
• Precision
• Robustness
• Reproducibility
• Throughput
• Regulatory suitability

The program considers newer approaches for improving that balance.

Immunostimulatory Drug Conjugates

The Emerging Technologies session also included:

Development of Cell-based Potency Assays For a Novel Immunostimulatory Drug Conjugate

presented by Marshall Davis of Pfizer.

This illustrates bioassay development for newer therapeutic modalities whose mechanisms may require specialized functional systems.

Fc-Receptor Bioassays

Another confirmed presentation was:

Development of Fc-Receptor Bioassays to Unravel the Impact of Glycosylation

presented by Caterina Giorno and Daniel Markx of Boehringer Ingelheim.

This topic connects:

Glycosylation → Fc Receptor Interaction → Functional Bioassay → Potency / Characterization

Cell & Gene Therapy

The final major scientific session was:

Cell and Gene Therapy and More!

Cell and gene therapies present particularly difficult potency challenges because biological activity can involve multiple steps and complex mechanisms.

Potency Assays for Complex Therapeutics

Developers working with advanced therapies must often design assays that balance:

• Biological relevance
• Manufacturing consistency
• QC practicality
• Reproducibility
• Regulatory requirements

This is especially important for cell therapy, viral-vector products, and other complex modalities.

Immunostimulatory Virus-Like Particle Products

The session included:

Overcoming Challenges in Potency Bioassay Development: A Case Study on an Immunostimulatory Virus-Like Particle Investigational Drug

presented by Cristinel Sandu of Regeneron.

The case illustrates the challenges involved when conventional potency-assay designs are not sufficient for newer product classes.

CAR Potency Assurance

Another presentation was:

Uniting for Success: Collaboration between Analytics, Research and Process Development for a CAR Potency Assurance Strategy

presented by Sonia Connaughton of Sanofi.

This emphasizes the multidisciplinary nature of potency strategy.

Successful development may require collaboration among:

• Analytical teams
• Research
• Process Development
• Manufacturing
• Regulatory functions

AAV Infectivity

The final scientific session also included:

Bridging Potency: Implementation of AAV Infectivity by Viral Entry Assay

presented by Ting He of Ultragenyx.

This highlights assay strategies relevant to adeno-associated virus – AAV gene therapy products.

Artificial Intelligence in Bioassays

Artificial intelligence was a dedicated roundtable topic:

Let’s Brainstorm on Applications of AI for Bioassays.

The inclusion of AI reflects growing interest in applying computational tools to:

• Data interpretation
• Assay development
• Method monitoring
• Automation
• Pattern recognition
• Analytical workflows

Method Comparability & Bridging

A dedicated roundtable addressed:

Method Comparability and Method Bridging: Are They the Same Thing?

This is particularly important when methods change during development or across laboratories, platforms, or product lifecycle stages.

Reagent & Equipment Lifecycle Management

Another roundtable focused on:

Life Cycle Management of Reagents and Equipment.

Bioassay performance can depend heavily on reagents, instruments, cells, and critical materials.

Effective lifecycle management therefore supports:

• Assay consistency
• Reproducibility
• Method continuity
• QC reliability

Reference Standards

The program included:

Managing the Potency of Your Reference Standards.

Reference standards are central to quantitative potency testing because the measured activity of a test sample is frequently interpreted relative to a qualified standard.

Monitoring Bioassay Method Health

Another roundtable asked:

How Are You Monitoring the Health of Your Bioassay Methods?

Ongoing method monitoring can help identify:

• Assay drift
• Reagent changes
• Cell-line changes
• Performance deterioration
• Unexpected variability

before they significantly affect routine testing.

Bioassay Lifecycle Management

Bioassay development does not stop after validation.

The 2025 program repeatedly addresses lifecycle considerations involving:

• Method performance
• Specifications
• Reference standards
• Reagents
• Equipment
• Comparability
• Bridging
• QC
• Product changes
• Commercialization

The broader lifecycle can be represented as:

Development → Qualification → Validation → Transfer → QC → Monitoring → Change Management

Potency Assays

Potency was one of the most prominent themes across Bioassays 2025.

The meeting examined potency strategies for:

• Conventional biologics
• Bispecific antibodies
• Multispecific molecules
• ADCs
• Fusion proteins
• Immunostimulatory conjugates
• Cell therapies
• Gene therapies
• AAV-based products

CASSS’s year-end review specifically identified potency assays as one of the central scientific themes of the 2025 symposium.

Regulatory Science

Bioassays 2025 combines scientific development with regulatory strategy.

This means assay decisions must be considered not only in terms of technical performance but also:

• Product mechanism
• Development phase
• Manufacturing control
• Specifications
• Regulatory submissions
• Quality control
• Lifecycle changes

The conference’s emphasis on both scientific approaches and regulatory strategies reflects this integrated CMC perspective.

Major Topics Covered

• Bioassays
• Bioassay Development
• Potency Assays
• Cell-Based Potency Assays
• Bioassay Method Development
• Bioassay Standardization
• CMC Strategy
• Regulatory Science
• Biologics
• Biological Activity
• Mechanism of Action
• MoA-Reflective Assays
• Quality Control
• Next-Generation QC
• Antibody-Dependent Cellular Phagocytosis
• ADCP
• Fc-Mediated Cytotoxicity
• Fc-Receptor Bioassays
• Afucosylation
• Glycosylation
• Multispecific Antibodies
• Bispecific Antibodies
• Elranatamab
• Product Variant Characterization
• Potency Specifications
• Antibody-Drug Conjugates
• ADCs
• ADC Potency Assays
• Bystander Killing
• High-Content Imaging
• Inducible Promoter Systems
• Biotherapeutic Fusion Proteins
• Immunostimulatory Drug Conjugates
• Cell Therapy
• Gene Therapy
• CAR Potency
• AAV
• AAV Infectivity
• Viral Entry Assays
• Virus-Like Particles
• Artificial Intelligence
• AI for Bioassays
• Method Comparability
• Method Bridging
• Reagent Lifecycle Management
• Equipment Lifecycle Management
• Reference Standards
• Method Monitoring
• Bioassay Lifecycle Management
• Emerging Bioassay Technologies

Who Should Take This Course?

CASSS Sharing Science Solutions Bioassays 2025 is particularly relevant for:

• Bioassay Scientists
• Analytical Scientists
• Potency Assay Scientists
• Biopharmaceutical Development Scientists
• Quality Control Scientists
• CMC Professionals
• Regulatory Professionals
• Cell-Based Assay Scientists
• Biologics Researchers
• Cell and Gene Therapy Scientists
• ADC Development Scientists
• Multispecific Antibody Scientists
• Immunologists
• Pharmacologists
• Clinical Pathologists
• Oncologists

The strongest scientific audience remains:

Bioassay Science + Biopharmaceutical Development + Potency Testing + Regulatory Strategy

Why This Course Is Useful

CASSS Sharing Science Solutions Bioassays 2025 provides a focused review of how bioassay science is evolving alongside increasingly complex biopharmaceutical products.

The curriculum connects several major areas:

Bioassay Foundations

• Assay development
• CMC strategy
• Method design
• Practical assay performance

Functional Potency

• Cell-based assays
• ADCP
• Fc biology
• Glycosylation

Complex Antibodies

• Bispecific antibodies
• Multispecific antibodies
• Product variants
• Potency specifications

Antibody-Drug Conjugates

• ADC potency
• High-content imaging
• Bystander killing
• Assay lifecycle management

Emerging Technology

• MoA-reflective assays
• AI
• New cell systems
• Advanced imaging

Cell & Gene Therapy

• CAR potency
• AAV infectivity
• Virus-like particles
• Advanced therapy assay development

Lifecycle & Regulatory Strategy

• Reference standards
• Method comparability
• Bridging
• Reagent management
• Method monitoring
• Quality control

The overall scientific pathway can be summarized as:

Understand Mechanism → Design Bioassay → Establish Potency → Characterize Performance → Validate → Implement in QC → Monitor Throughout Lifecycle

Product Summary

• Product: CASSS Sharing Science Solutions Bioassays 2025
• Official Program: Bioassays 2025: Scientific Approaches and Regulatory Strategies
• Organization: CASSS – Sharing Science Solutions
• Year: 2025
• Dates: April 7–9, 2025
• Venue: Gaithersburg Marriott Washingtonian Center
• Location: Gaithersburg, Maryland
• Primary Field: Biopharmaceutical Analytical Science
• Primary Focus: Bioassay Development and Regulatory Strategy
• Major Modalities: Biologics, Bispecific/Multispecific Antibodies, ADCs, Cell & Gene Therapy, AAV
• Major Analytical Areas: Potency Assays, Cell-Based Bioassays, QC, Reference Standards, Method Lifecycle Management
• Primary Audience: Bioassay Scientists, Analytical Scientists, QC and Regulatory Professionals
• Additional Audience: Immunologists, Pharmacologists, Clinical Pathologists, and Oncologists

Short Description

CASSS Sharing Science Solutions Bioassays 2025 is a leading scientific symposium focused on current approaches, technologies, and regulatory strategies for bioassay development and potency testing.

Held April 7–9, 2025, in Gaithersburg, Maryland, the program covers bioassay foundations, cell-based potency assays, multispecific and bispecific antibodies, ADCs, Fc-mediated biology, emerging technologies, AI, reference standards, method comparability, cell and gene therapy, CAR potency strategies, and AAV infectivity assays.

Topics

Monday, April 7, 2025

• WATCH NOW: Development of a New Class of Target Cell Lines to Evaluate Fc-Mediated Cytotoxicity
• Workshop Part I – Introduction to Bioassay Development: CMC Strategy and Practical Application
• Workshop Part II – Practical Applications for Method Design and Performance

Tuesday, April 8, 2025

• CASSS Welcome and Introductory Comments
• Keynote Presentation – The Special World of Bioassay: Key Learnings, Special Situations and Keys to Success
• Session I: Bioassays Foundations / Nuts and Bolts of Bioassays
  • A Novel Cell-Based Potency Assay to Measure Cell/Cell Phagocytosis Induced by Antibody-Dependent Cellular Phagocytosis
  • Afucosylation: Potency Evaluation Strategies
  • Of Mice and (Wo)Men
• Session I: Panel Discussion
• Session II: Bioassay Strategies for Multi-Specific Antibodies
  • Navigating the Complexities of Bi-Specifics: Leveraging Bioassays for Product Variant Characterization and Process Development
  • Elranatamab: Bispecific mAb Bioassay Strategy from R&D to Commercialization
  • Bridges Over Montgomery County: Revamping the Potency Specification Strategy for a Complex Modality
• Session II: Panel Discussion
• Poster Session
• Roundtable Session 1
  • Let’s Brainstorm on Applications of AI for Bioassays
  • Method Comparability and Method Bridging: Are They the Same Thing?
  • Life Cycle Management of Reagents and Equipment
  • Managing the Potency of Your Reference Standards
  • How Are You Monitoring the Health of Your Bioassay Methods?
• Emerging Professionals Session
  • Development of an in Vitro Bystander Killing Bioassay for ADCs
  • Potency Control Strategy for Biotherapeutic Fusion Proteins

Wednesday, April 9, 2025

• Session III: Antibody Drug Conjugates
  • Navigating Complexity: A Strategic Framework for Streamlining and Simplifying Antibody Drug Conjugates Development and Potency Assay Lifecycle Management
  • Inducible Promoter Systems: Pioneering the Future of Bioassay Development for Enhanced Precision Control
  • Use of High Content Imaging to Enable Cell-Based Potency Assay Development for ADCs
• Session III: Panel Discussion
• Roundtable Session 2
  • Let’s Brainstorm on Applications of AI for Bioassays
  • Method Comparability and Method Bridging: Are They the Same Thing?
  • Life Cycle Management of Reagents and Equipment
  • Managing the Potency of Your Reference Standards
  • How Are You Monitoring the Health of Your Bioassay Methods?
• Poster Session
• Session IV: Emerging Technologies / Innovations in Bioassays
  • MoA-Reflective Bioassays for Next-Gen QC Testing
  • Development of Cell-based Potency Assays For a Novel Immunostimulatory Drug Conjugate
  • Development of Fc-Receptor Bioassays to Unravel the Impact of Glycosylation
• Session IV: Panel Discussion
• Session V: Cell and Gene Therapy and More!
  • Overcoming Challenges in Potency Bioassay Development: A Case Study on an Immunostimulatory Virus-Like Particle Investigational Drug
  • Uniting for Success: Collaboration between Analytics, Research and Process Development for a CAR Potency Assurance Strategy
  • Bridging Potency: Implementation of AAV Infectivity by Viral Entry Assay
• Session V: Panel Discussion
• Closing Remarks and Invitation to Bioassays 2026

 

Topics

• CASSS Welcome and Introductory Comments

• Keynote Presentation: The Special World of Bioassay Key Learnings Special Situations and Keys to Success

• Session I: Bioassays Foundations Nuts and Bolts of Bioassays

• Session I: Panel Discussion

• Session II: Bioassay Strategies for Multi-Specific Antibodies

• Session II: Panel Discussion

• Session III: Antibody Drug Conjugates

• Session III: Panel Discussion

• Session IV: Emerging Technologies Innovations in Bioassays

• Session IV: Panel Discussion

• Session V: Panel Discussion

• Development of a New Class of Target Cell Lines to Evaluate Fc-Mediated Cytotoxicity Presented by Svar Life Science

• Lunch and Learn Vendor Showcase

• Closing Remarks and Invitation to Bioassays 2026