CASSS Sharing Science Solutions CMC Strategy Forum North America WCBP 2026

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+ Target Audience: Medical Geneticists, Clinical Pharmacologists, Molecular Pathologists, and Preventive Medicine Specialists

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The CASSS CMC Strategy Forum North America & WCBP 2026 is a premier scientific symposium focused on the latest advancements and regulatory strategies in the Chemistry, Manufacturing, and Controls (CMC) of biopharmaceuticals. The event provides a collaborative platform for industry experts and regulatory authorities to discuss critical topics such as artificial intelligence integration, accelerated stability studies, analytical characterization of complex modalities, and global regulatory convergence, aiming to accelerate the delivery of high-quality therapeutics to patients worldwide.

Learning Objectives

• Implement artificial intelligence and machine learning strategies to streamline process development, analytical method creation, and regulatory submissions.

• Develop robust CMC strategies and analytical control methods for complex multi-specific antibodies, personalized gene editing therapies, and mRNA vaccines.

• Navigate the evolving landscape of global regulatory reliance, cloud-based digital reviews, and structured product quality submissions (ICH M16).

• Apply advanced analytical technologies, including LC-MS, capillary electrophoresis, and peptide mapping, to characterize biotherapeutics and monitor degradation products.

• Formulate risk-based strategies for controlling sub-visible particulates in ophthalmic biologics and evaluating the clinical impact of silicone oil droplets.

Target Audience

• This program is targeted to analytical scientists, CMC regulatory affairs specialists, process development engineers, and quality assurance/control experts in the biopharmaceutical industry.
• Best for Medical Geneticists, Clinical Pharmacologists, Molecular Pathologists, and Preventive Medicine Specialists.

Topics

• 30th Anniversary Workshop Pet Peeves and Roadblocks in CMC Improving your Quality Submissions through the Product Lifecycle

• ACCESS Worksharing Operational Insights and Process Optimization

• Acknowledgements Closing Remarks Invitation to WCBP 2027

• Advancing Biomanufacturing and Regulatory Modernization Innovation, Implementation, Operationalization

• Advancing Biotherapeutic Analysis Through Capillary Electrophoresis Presented by Bio-Techne

• B7-H7 Bispecific Antibody Development Protein Engineering and Product Quality-Focused Cell-Line Development to Minimize…

• Best Practices in Peptide MapMSMS Analysis of Degradation Products and Disulfide Linkage Analysis

• Beyond Borders Scaling Biologics Post-Approval Changes Through Regulatory Reliance and Cloud-Based Digital Review

• Building a Resilient Commercial Supply Chain for Antibody-Drug Conjugate Products A Risk-Based Comparability Approach

• Building End-End Vaccine Development and Manufacturing Capability in Africa – The South African Experience

• Case Study of Dose Delivered vs Label Claim in Different Delivery Systems

• CASSS Welcome 14th Annual Hancock Award WCBP 2026 Introduction

• CASSS Welcome and CMC Strategy Forum 2026 Introductory Comments

• Challenges and Best Practices for Global Implementation of Analytical Procedures –Use of the Analytical Target Profile as Described…

• Challenges When Working with Contract Development Manufacturing Organizations (CDMOs)

• Closing Remarks Invitation to CMC Strategy Forum Summer 2026

• CMC Strategy Forum North America 2026 Summer Scientific Program & Infographic

• Code, Care, and Conscience How AI, Ethics, and Lived Experience Are Redefining the Future of Pharma

• Collaborative CMC Assessment of Post-Approval Change Management Protocols A Regulatory Health Authority-Perspective

• Compendial Expectations for Dose Content and Uniformity for Biologics

• Control Strategies Tailored for Multispecifics

• Controlling Particulate Matter in Ophthalmic Biologics Establishing a Risk-Based Analytical Approach to Sub-Visible Particulates

• Designing a Lyophilized Drug Product for Weight-Based Dosing

• Designing the AI-Enabled CMC Ecosystem for Drug Development and Manufacturing

• Developing and Deploying Personalized Gene-Editing Therapies

• Digital Innovation for Sustainable, Accelerated Development in an Era of Uncertainty

• Enabling Global Pharmaceutical Innovation

• Enabling the Future of Biopharmaceutical Manufacturing Through Collaborative Innovation

• Ensuring Drug Product Content Meets Label Claim — Are You Getting What You Paid For

• Evaluating Clinical Safety and Analytical Impact of Subvisible Silicone Oil Droplets in Biopharmaceutical Products

• Expectations for the Development and Application of Extended Characterization Methods

• Fireside Chat with FDA Commissioner Dr Marty Makary

• From Construction to End-to-End Drug Substance and Drug Product GMP Manufacturing of mRNA Vaccines in Africa A Cross-C…

• From Developability to Commercial Readiness The New Reality of ICH Q1 Stability Presented by Catalent Inc.

• From Policies to Practices Health Canada’s Approach to Modernization of CMC Review

• Host Cell Protein Assays – Are We Still Relying on Conventional Quantification by Enzyme-Linked Immunosorbent Assays (ELISAs)

• Host Cell Proteins (HCP) and Host Cell DNA Risk Assessment for Gene Therapies

• How to Move from Pilot Initiatives to Sustainable Programs

• ICH M16 – Transitioning to Structured Product Quality Submissions

• ICH Q1 Guideline Revisions Risk Frameworks and Regulatory Readiness

• ICH Q1 Stability Guideline Revision – Whats New

• ICH Q14 Enhanced Approaches From ATP to Analytical Procedure Validation Using Prior Knowledge and Development Data

• ICHQ6 – Challenges and Opportunities for Using an Enhanced Approach to Lifecycle Management of Specifications

• Insights to Industry Led CMC PAC Reliance Pilots on Behalf of EFPIA

• Integrating Artificial Intelligence into Pharmaceutical Manufacturing

• International Collaboration and Reliance

• Interpreting Confidence Intervals in Analytical Validation under ICH Q2(R2) From Statistical Reporting to Decision-Making

• Introduction to Session – AI in Development and Manufacturing – New Era in Well Characterized Biologics

• In-Use Studies – Compatibility and Stability Studies

• Investigating the Root Cause of Biotherapeutic Coloration and Charge Heterogeneity During Cell Culture Processes Presented by…

• IQ Survey Results Industry Approaches to Allowable Content in Vials

• Keynote Presentation I – Moving a Genome Edited Stem Cell Based Therapy from the Bench to the Bedside

• Keynote Presentation II – Code Care and Conscience How AI Ethics and Lived Experience Are Redefining the Future of Pharm…

• Keynote Session III – The Heart of Innovation Patients Shaping the Future of Biologics

• Keynote Speaker – Michael Sheahan, Danforth, Health, Inc.

• Late-Stage CMC Analytical Speed Bumps When Later is Suddenly Now

• Leveraging Reliance for Accelerating Global Access to Vaccines A GSK Case Study

• Machine Learning-Supported (Process) Models Promises and Practical Implementation Challenges

• Mini Case Session 1 – Advances in Process Analytics and Real Time Release Testing (RTRT)

• Mini Case Session 1 – Case Studies of Characterization of Minor Degradation Products from High Performance Liquid Chromatography (HPLC) or Capillary Electrophoresis (CE) Me

• Mini Case Studies Session 2 – Cloud-Based Platforms for Regulatory Submissions Project PRISM and Accumulus CMC Use Cases

• Near-Concurrent Collaborative Reliance with Accumulus Technologies to Streamline Post-Approval Variations

• No AI Without Architecture FHIR as the Data Foundation

• Novel Applications of Molecular and Structural Biology in Characterization of ATMPs / Well Characterized Biologics

• Operationalizing Modern CMC Lifecycle Management The Digital Infrastructure Behind Collaborative Regulatory Execution

• Overcoming Barriers to local GMP Manufacturing and testing in LMICs Doing Things we never had

• Parallel Sessions (AI in Development and Manufacturing, What’s New in the World of Stability, Emerging Regulatory and Quality Expectations on Particulate Matter, Unblocking Regulatory Barriers, Emerging Therapeutic Modalities, Use of Reliance Pathways, Navigating the Comparability Maze, Overcoming Barriers to Local GMP Manufacturing)

• Pivoting to Platform A Case Study in Leveraging Reliance to Enable Fast Implementation of Platform Method for Commercial Products

• Plenary Session 3 – Global Regulatory Panel Working Together to Do More with Less

• Plenary Session 7 Panel Discussion – Modernizing CMC Regulatory Submissions

• Predictive Stability for Biopharmaceuticals & Vaccines Accelerating Patient Access through Industry Recommendations and Stakeholder Alignment

• Recent Trends in Questions from Health Authorities

• Regulatory Considerations for Early-Stage Development of Bi- Tri- and Multi-Specific Therapeutics

• Regulatory Considerations for Multispecific Antibody-Based Products for BLA and Beyond

• Risk-Benefit Appropriate Platform Manufacturing for Personalized Gene Editing

• SAHPRA Support for Local GMP Manufacturing and Quality Testing

• Side-by-Side Stress Studies Designed to Support Post-Change Shelf Life

• Speed to Clinic – Phase-Appropriate Strategies to Accelerate CMC Development Timelines

• Strategies for Analytical Characterization of Multi-Specific Proteins

• Strategies for Leveraging Clinical Stability Data for Commercial Shelf Life

• Strategies for Successful Development and Manufacturing of Multi-Specific Antibodies and Proteins

• Strategies to Support Right Dose Every Time How to Meet Label Claim

• Tackling the Polysorbate Degradation Challenge Control Strategies and Case Studies Presented by Clear Solutions Laboratories AG

• Technical Seminars Presented by Catalent, Inc., Clear Solutions Laboratories AG, Cygnus Technologies, LLC, KBI Biopharma, Inc., and USP

• The Need for Science and Risk-Based Approaches to Setting Specifications A Regulatory Perspective

• The Road Ahead – Whats Next for Host Cell Protein Analytics Presented by Cygnus Technologies LLC

• Transforming QC with MAM High-Resolution LCMS for Product Quality Monitoring Presented by Agilent Technologies Inc

• Use of Artificial Intelligence for Process and Analytical Method Development

• Use of Chromatography Resins Across Multiple Products

• Use of Machine Learning (ML) and Artificial Intelligence (AI) in Content Creation of Early Phase Development and Managing Submissions and Information Requests with Health Authorities

• Use of Predictive Stability for Shelf-Life Extension, ICH Q1 Annex 2

• Using Accelerated Degradation Studies to Support Comparability Assessments

• Vaccine Potency – Compare and Contrast Potency Tests for Different Vaccine Modalities

• Vaccine Specific Regulatory Considerations

• Visible Particle Control in Biologics and Advanced Therapy Products Challenges Case Studies and Evolving Expectations

• WCBP 2026 Scientific Program & Summary Infographic

• Welcome Day 3 CASSS Distinguished Fellow Presentation

• What’s New in the World of Stability Testing Updates on ICH Q1Q5C Revisions

• Workshop Sessions (Making Creative Protein Therapies a Reality, Right Dose Real Impact Strategies, Rethinking Specifications in ICH Q6, Partnering with CMOs and CTOs, Navigating Comparability Across Drug Delivery Presentations, Latest Learning From AI as a Tool, Opportunities and Challenges of Expanding US-based Manufacturing, Comprehensive Approach for Technology Transfers, In-Use Compatibility and Stability Studies, Qualification of Potency Reference Standards, Troubleshooting Technology Transfers Together)