CASSS Sharing Science Solutions CMC Strategy Forum North America WCBP 2025

This collection brings together CMC strategy and analytical science from two linked CASSS meetings in Washington, D.C. The CMC Strategy Forum North America took place January 27, 2025, followed by WCBP on January 28–30 at The Mayflower Hotel; a bioassay pre-conference workshop was also scheduled for January 27. The forum focused on AI and data analytics in development, and patient-centered quality standards. WCBP extended the discussion to product characterization, microbiological control, combination products, advanced manufacturing, and global regulatory strategy. Presentations, workshops, panels, and case discussions are relevant to analytical, process development, quality, and regulatory professionals working across the biopharmaceutical lifecycle.

Learning Objectives

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

• Implement artificial intelligence, machine learning, and automation to accelerate bioprocess development, formulation, and data modeling while ensuring regulatory compliance.
• Apply advanced analytical technologies, including LC-MS, capillary electrophoresis, and native mass spectrometry, for comprehensive biotherapeutic characterization and host cell impurity control.
• Develop robust control strategies and specifications for complex formulations, combination products, and advanced therapies such as cell and gene therapies and vaccines using prior knowledge and risk-based approaches.
• Evaluate and transition toward alternative endotoxin testing methodologies, including approaches moving away from horseshoe crab-derived reagents, while managing challenges related to low endotoxin recovery.
• Navigate the global regulatory landscape to manage post-approval changes, leverage CDMO/CTO networks, and support movement toward a unified One Global CMC Dossier.

WCBP keynote: Sonia Vallabh, PhD, Broad Institute, presented “The Road to Preventing Prion Disease: Opportunities, Challenges, and My Personal Mandate.”

Program scope: The dates distinguish the Forum, WCBP symposium, and pre-conference workshop. Program listings do not establish that every concurrent workshop or session is included in the supplied files. Provider registration, live attendance, streaming-platform access, memberships, apps, accounts, and publisher-hosted extras are not included unless explicitly listed as store files.

Topics

• Advanced Manufacturing

• AI-Accelerated Stability for Biologics

• Allowable Excess Volume and Gross Content Requirements for Injectable Drug Products Filled in Vials or Ampules

• Applications of Artificial Intelligence – Machine Learning and Automation

• Bacterial Endotoxin Testing Progressive Science and Sustainability

• Best Practices in Host Cell Impurity Analytics Using Advanced Technologies and Methods

• Bridging Session – Leveraging Contract Organization Networks to Enhance Patient Access in Lower and Middle-Income Countries

• Case Studies for Patient-Centric Specification Setting for a Therapeutic Protein and IQ Readout on Endotoxin Acceptance Criteria

• CASSS Welcome 13th Annual Hancock Award WCBP 2025 Introduction

• CMC Challenges with Complex Formulations – Excipient Selection and Impact on Product Stability and Process Consistency

• CMC Paths to Patients for Small and Virtual Biotechs

• Community Voices Sunrise Chats

• Comprehensive Characterization of Biotherapeutics Using Orthogonal Capillary Electrophoresis CE Liquid Chromatography-Mass Spectrometry LC-M

• Considerations for Developing an Autoinjector Control Strategy

• Coupling Mass Spectrometry MS with non-MS Assays for Automated Profiling of Antibody Impurities

• Critical Attributes Analysis and Method Lifecycle Management for Biologics and ATMPs

• Defining the Microbial Control Strategy for Low Endotoxin Recovery Impacted Biologics

• Delivering COVID Variant Vaccines in 100 days

• Development of Realistic and Safe AIML Applications for Biotherapeutic Characterization and Process Development

• Empowering 5.0 BioSolutions Through Realtime PAT and Computational Controls

• Enhanced Approaches Support Robust Harmonized Vaccine Potency Specifications

• Fix-Dose Co-Formulated Protein Product in Liquid or Solid

• Genetic Medicine Characterization via 2nd and 3rd Generation Sequencing Tools

• Global Access to Medicines in Underserved Regions

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

• How Industry and Regulatory Innovation and Collaboration Can Promote the Transition From in Vivo to in Vitro Potency Testing

• How to Effectively Manage CMC Post-Approval Changes

• How to Incorporate Prior Knowledge What Are Bayesian Statistics and Why Non-Statisticians Should Be Interested

• Initiatives from Industry An Update from the PSCI Horseshoe Crab Blood Working Group

• IQ Biologics Specifications Setting Challenges and Opportunities Working Group Endotoxin Subgroup Readout

• Keynote Presentation – The Road to Preventing Prion Disease Opportunities Challenges and My Personal Mandate

• Leveraging Biotransformation Data to Refine Bioprocesses and Derisk PQAs

• Maintaining an Integrated Control Strategy Throughout Combination Product Lifecycle Changes

• Managing More With Less – the Power of Platforms

• Managing/Leveraging CMOs and CTOs for Lifecycle Success

• Method Transfer Challenges at CMOs CROs

• Microbiological Submission Roadblocks

• Mini Case Sessions (Accelerating Post Approval Changes, Use of Predictive Stability, Applying Prior Knowledge, Assessment of Visible Particles)

• Molecule-Independent Device Bridging Approach (MIDBA)

• Moving Away from Animal Testing and Animal Derived Components Including Alternate Endotoxin Test

• Navigating 2-Tier Reference Standard Strategy for Biologics

• Overcoming Low Endotoxin Recovery from Theory to Practice

• Parallel Sessions (Alternative Potency Assays, LER Strategies, Integrated Control Strategy for Combination Products, Immunogenicity Risk, Prior Knowledge, Protecting the Horseshoe Crab)

• Partnering with CDMOs A Strategic Primer for Startups

• Plenary Sessions (Global Convergence, Harnessing Established Analytical Technologies, Strength in Partnership)

• Practical and Regulatory Considerations for Machine Learning Models

• Predictive Stability for Biologics Using Kinetic Modeling

• Recent Trends in Questions from Global Health Authorities

• Regulatory Expectations for Data Models to Support a Marketing Application

• Relevance of Accelerated and Forced Degradation Studies for a Frozen DS DP

• Replacement of in vivo Immunogenicity Assay with in vitro Antigenicity ELISA for Pertactin Antigen in Acellular Pertussis Combination Vaccines

• Setting Specification for Not Well-Characterized Biological Products, e.g., Cell and Gene Therapy Products

• Setting Specifications on Limited Data, Clinically Relevant Specs Next Generation Control Strategies

• Tech Transfer Challenges and How to Avoid Common Mistakes

• Technical Seminars (Agilent Technologies, Catalent Biologics, LumaCyte, SCIEX, Waters Corporation)

• The Challenge and Criticality of Data Contextualization to Support Effective AIMLModeling in Bioprocess Development

• The Road to One Global CMC Dossier

• Troublesome Issues Seen in Biologics Development in Academic Spaces and Small Startup Companies

• Turning Mandates into Momentum How CASSS Can Help Sonia Vallabh

• Unmatched Capability to Elucidate the Complex Size and Charge Variants of Protein Therapeutics using Native Mass Spectrometry with the Orbit

• Vaccine Manufacturing New Technologies for mRNA Production

• WATCH NOW How to Maximize Value from Protein Metrics New Multi-Protein Quantitation Workflows

• Welcome Day 3 Plenary Session 7 – Navigating the Small and Virtual Business Landscape Managing More with Less

• What Are the New Alternate Lipids for Lipid Nanoparticles

• What Do Crabs Have to Do with Birds Have to Do with People

• What Is Meant by Patient-Centric Quality Standards

• Wide-Spread Adoption of High-Volume Delivery Subcutaneously – What’s the Hold-Up

• Workshop Sessions (Digital Transformation, Patient Centric Quality Standards, Predictive Stability, Endotoxin Testing, Platform Analytical Procedures, Platform Designation Guidance, Sterilization Validation, Artificial Intelligence)