CASSS Sharing Science Solutions CMC Strategy Forum North America WCBP 2026

CASSS CMC Strategy 2026: Forum North America and WCBP

Biopharmaceutical CMC Strategy, Analytical Technologies, Artificial Intelligence, Regulatory Science, Stability, Complex Biologics & Global Quality Submissions

The CASSS Sharing Science Solutions CMC Strategy Forum North America WCBP 2026 brings together two major scientific programs focused on the rapidly evolving field of biopharmaceutical Chemistry, Manufacturing, and Controls (CMC), analytical science, manufacturing technology, product quality, and regulatory strategy.

Presented by CASSS – Sharing Science Solutions, the combined 2026 program brought together experts from the pharmaceutical and biotechnology industries, global regulatory agencies, academia, analytical sciences, process development, manufacturing, and quality organizations.

The event consisted of the CMC Strategy Forum North America 2026 on January 26, followed by the WCBP Symposium 2026 from January 27–29, 2026.

Together, these programs examined emerging challenges across the complete biopharmaceutical product lifecycle, including artificial intelligence and machine learning, advanced analytical characterization, predictive stability, complex therapeutic modalities, structured regulatory submissions, global regulatory reliance, process analytics, particulate control, gene therapy analytics, vaccine manufacturing, and modern biopharmaceutical quality systems.

Course Details

• Course: CASSS Sharing Science Solutions CMC Strategy Forum North America WCBP 2026
• Provider: CASSS – Sharing Science Solutions
• CMC Strategy Forum Date: January 26, 2026
• WCBP Dates: January 27–29, 2026
• Location: The Mayflower Hotel, Washington, D.C., USA
• Format: In-Person + Live Stream / Virtual Participation
• Primary Focus: Biopharmaceutical CMC and Analytical Science
• Additional Focus: Regulatory Affairs, Pharmaceutical Manufacturing, Quality, Biotechnology and Advanced Therapeutics
• Program Components: Scientific Presentations, Panel Discussions, Workshops, Mini Case Studies, Roundtables and Technical Seminars

Target Audience

This program is designed primarily for professionals involved in the development, manufacturing, characterization, regulation, and quality control of biological and biotechnology-derived medicines.

The target audience includes:

• Analytical Scientists
• CMC Regulatory Affairs Specialists
• Biopharmaceutical Scientists
• Process Development Scientists
• Pharmaceutical Manufacturing Professionals
• Quality Assurance Specialists
• Quality Control Scientists
• Regulatory Scientists
• Biotech Researchers
• Pharmaceutical Development Scientists
• Formulation Scientists
• Stability Scientists
• Method Development Scientists
• Biologics Characterization Specialists
• Gene Therapy Scientists
• Vaccine Development Professionals
• Regulatory Agency Professionals
• Academic Researchers
• Clinical Pharmacologists
• Medical Geneticists
• Molecular Pathologists
• Pharmaceutical Scientists

The meeting is especially relevant for professionals working at the interface of science, product quality, manufacturing, and global regulation.

Program Overview

Modern biopharmaceutical development increasingly involves products and manufacturing systems that are more complex than traditional monoclonal antibodies.

Developers must now address challenges involving:

• Multispecific molecules
• Advanced biologics
• Gene therapies
• Vaccines
• mRNA-based technologies
• Drug-device combinations
• Complex delivery systems
• Advanced analytical technologies
• Large digital datasets
• Artificial intelligence
• Global manufacturing networks

At the same time, regulatory agencies are moving toward increasingly digital, structured, collaborative, and data-driven assessment models.

The CMC Strategy Forum North America / WCBP 2026 examines these changes from both scientific and regulatory perspectives.

Learning Objectives

After completing the educational material, learners should be better prepared to:

• Evaluate applications of artificial intelligence and machine learning in process development, analytical method development, manufacturing, data interpretation, and CMC regulatory activities.
• Develop scientifically justified CMC and analytical control strategies for increasingly complex biopharmaceutical products and advanced therapeutic modalities.
• Understand emerging approaches to structured product-quality submissions, including the evolving ICH M16 framework.
• Assess opportunities and challenges associated with cloud-based regulatory platforms and collaborative digital review environments.
• Apply modern analytical technologies to the characterization of biotherapeutics and degradation products.
• Interpret analytical information generated using chromatography, capillary electrophoresis, mass spectrometry, peptide mapping, and related characterization techniques.
• Understand current approaches to predictive and accelerated stability assessment in biologics and vaccines.
• Develop risk-based strategies for visible and sub-visible particulate control in biopharmaceutical products.
• Evaluate the analytical and potential clinical relevance of silicone-oil droplets in injectable and ophthalmic biological products.
• Understand evolving approaches to global regulatory reliance, harmonization, and collaborative CMC assessment.

CMC Strategy Forum North America 2026

Making Creative Protein Therapies a Reality for Patients

The 2026 CMC Strategy Forum focused on emerging scientific and regulatory challenges associated with increasingly sophisticated protein therapeutics.

The program examined how the traditional CMC framework must evolve as manufacturers develop products with greater structural and functional complexity.

Relevant considerations include:

• Molecular complexity
• Product heterogeneity
• Manufacturing consistency
• Potency
• Dose delivery
• Analytical control
• Product specifications
• Regulatory expectations

Right Dose, Real Impact

A major CMC Strategy Forum workshop addressed strategies for helping ensure that patients consistently receive the intended dose of injectable products.

This topic connects:

• Product quality
• Manufacturing
• Allowable content
• Device performance
• Administration
• Patient exposure

and demonstrates how CMC decisions can ultimately influence clinical product performance.

Artificial Intelligence in CMC Development

Artificial intelligence was one of the major themes across the 2026 program.

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

Pablo Rolandi – Amgen Inc.

Examines how AI can become integrated into pharmaceutical development and manufacturing rather than remaining limited to isolated pilot projects.

Potential areas include:

• Process optimization
• Predictive modeling
• Data integration
• Manufacturing intelligence
• Decision support
• Knowledge management

Integrating Artificial Intelligence into Pharmaceutical Manufacturing

Tina Kiang – FDA/CDER

Provides a regulatory perspective on the expanding use of artificial intelligence within pharmaceutical manufacturing.

Important considerations include:

• Data quality
• Model reliability
• Validation
• Regulatory use
• Traceability
• Lifecycle management

AI in Development and Manufacturing – A New Era in Well Characterized Biologics

Gert Thurau – F. Hoffmann-La Roche Ltd.

Explores how advanced computational methods may transform the characterization, development, and manufacturing of biological products.

AI & Machine Learning for Analytical Development

Dedicated CASSS discussions examined the:

Use of Artificial Intelligence for Process and Analytical Method Development

and the:

Use of Machine Learning and Artificial Intelligence in Content Creation, Early-Phase Development and Regulatory Information Requests

These topics demonstrate the increasing role of AI not only in laboratory science but also in the generation, organization, review, and management of regulatory CMC information.

Predictive Stability for Biopharmaceuticals & Vaccines

Predictive Stability for Biopharmaceuticals & Vaccines: Accelerating Patient Access Through Industry Recommendations and Stakeholder Alignment

Daniel Skomski – Merck & Co., Inc.
Andrea Ji – Genentech / Roche

Examines approaches that use stability modeling and scientifically justified predictive strategies to potentially accelerate product development and availability.

Relevant areas include:

• Stability modeling
• Shelf-life prediction
• Degradation pathways
• Accelerated studies
• Risk assessment
• Regulatory acceptance

ICH Q1 & Stability Guideline Evolution

What’s New in the World of Stability Testing? Updates on ICH Q1/Q5C Revisions

Ashutosh Rao – FDA/CDER

Reviews evolving international expectations for stability assessment.

ICH Q1 Guideline Revisions: Risk Frameworks and Regulatory Readiness

Paula Russell – Health Canada

Examines how revised stability frameworks may influence development and regulatory strategy.

Use of Predictive Stability for Shelf-Life Extension

Linda Lemieux – Merck & Co., Inc.

Explores how predictive information may support shelf-life decisions within emerging ICH stability frameworks.

ICH M16 – Structured Product Quality Submissions

ICH M16 – Transitioning to Structured Product Quality Submissions

Rodrigo Palacios – F. Hoffmann-La Roche Ltd.

One of the most important regulatory topics in the 2026 program is the shift toward structured product-quality information.

ICH M16 is intended to advance the organization and digital exchange of pharmaceutical quality information.

Potential benefits include:

• More standardized submissions
• Improved data reuse
• Easier information exchange
• More efficient regulatory review
• Better lifecycle management
• Greater global consistency

Cloud-Based Regulatory Submissions

Project PRISM and Accumulus CMC Use Cases

A dedicated mini-case session examines cloud-based platforms for regulatory submissions and collaboration.

This reflects a broader shift away from static document exchange toward modern digital environments that may allow regulators and sponsors to interact with structured data more efficiently.

Global Regulatory Reliance

The program explores strategies that can reduce duplication and improve international regulatory efficiency.

Pivoting to Platform: Leveraging Reliance for Commercial Analytical Methods

Christine Wu – Genentech / Roche

Examines how regulatory reliance and platform approaches may accelerate implementation of analytical methods across markets.

Collaborative CMC Assessment of Post-Approval Change Management Protocols

Willie Wilson – FDA/CDER

Provides a regulatory health-authority perspective on collaborative assessment of post-approval CMC changes.

Advanced Analytical Characterization

Modern biologics require sophisticated analytical technologies capable of detecting subtle structural and chemical changes.

The program addresses techniques including:

• High-Performance Liquid Chromatography
• Capillary Electrophoresis
• Mass Spectrometry
• LC-MS
• Peptide Mapping
• MS/MS
• Structural Biology
• Molecular Characterization
• Process Analytical Technologies

Characterization of Minor Degradation Products

A dedicated mini-case session explores:

Characterization of Minor Degradation Products from HPLC or Capillary Electrophoresis Methods

The objective is to understand how low-level degradation products can be identified, characterized, and evaluated for their potential impact on product quality.

Peptide Mapping & Mass Spectrometry

The 2026 roundtables include:

Best Practices in Peptide Map/MS/MS Analysis of Degradation Products and Disulfide Linkage Analysis

These methods can provide detailed structural information about:

• Protein sequence
• Post-translational modifications
• Degradation products
• Disulfide bonds
• Structural integrity

Process Analytics & Real-Time Release Testing

Advances in Process Analytics and Real Time Release Testing

This mini-case session examines how enhanced process measurement and analytical technologies may support:

• Improved manufacturing control
• Faster quality decisions
• Better process understanding
• Real-time or near-real-time product release strategies

Complex & Multispecific Products

As biological medicines become more complex, traditional characterization and control strategies may require modification.

A 2026 workshop specifically addresses:

Qualification of Potency Reference Standards for Multispecifics, Multiple Antigens and Multiple Mechanisms of Action

This is particularly relevant for advanced biological products in which a single molecule may have multiple binding targets or biological functions.

Gene Therapy Analytical Challenges

CASSS 2026 also addresses quality-control challenges specific to gene therapies.

Roundtable topics include:

• Host Cell Protein Risk Assessment
• Host Cell DNA Risk Assessment
• Advanced structural characterization
• Analytical strategies for advanced therapy medicinal products

These issues are critical because gene therapies may involve complex manufacturing platforms and unique impurities that differ significantly from traditional biologics.

mRNA Vaccines

From Construction to End-to-End Drug Substance and Drug Product GMP Manufacturing of mRNA Vaccines in Africa

Petro Terblanche – Afrigen Biologics

Examines the establishment of end-to-end manufacturing capabilities for mRNA vaccines.

The session connects:

• Technology transfer
• GMP manufacturing
• Drug substance
• Drug product
• Regional production
• Pandemic preparedness
• Public-health impact

Vaccine Potency & Regulatory Strategy

The WCBP program includes discussions addressing:

• Vaccine potency
• Different vaccine modalities
• Vaccine-specific regulatory considerations
• Analytical control
• Manufacturing consistency

These discussions are increasingly important as vaccine technologies diversify beyond traditional platforms.

Sub-Visible Particulates in Ophthalmic Biologics

Controlling Particulate Matter in Ophthalmic Biologics

Lauren C. Jones – Regeneron Pharmaceuticals Inc.

Reviews development of a risk-based analytical approach to sub-visible particulates in ophthalmic biological products.

Important considerations include:

• Particle size
• Product quality
• Container systems
• Analytical measurement
• Regulatory expectations
• Potential patient impact

Silicone Oil Droplets

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

Miguel Saggu – Genentech / Roche

Examines an important issue associated with prefilled syringes and other delivery systems.

Silicone oil can generate particles that complicate both analytical measurements and clinical risk assessment.

This session reviews the relationship between:

• Container closure systems
• Silicone oil
• Sub-visible particles
• Analytical methods
• Ophthalmic products
• Clinical safety considerations

Visible Particle Control

Visible Particle Control in Biologics and Advanced Therapy Products

Atanas Koulov – Clear Solutions Laboratories AG

Examines the challenges of detecting, interpreting, and controlling visible particles across biologics and advanced therapeutic products.

Specifications & ICH Q6

A dedicated workshop asks how pharmaceutical specifications should evolve from simple batch-data limits toward clinically meaningful product-control strategies.

From Batch Data to Patient Needs: Rethinking Specifications in ICH Q6

Major considerations include:

• Critical quality attributes
• Patient relevance
• Manufacturing capability
• Statistical interpretation
• Lifecycle management
• Risk-based control strategies

Technology Transfer

Several sessions address transferring manufacturing and analytical processes between organizations or facilities.

Topics include:

• Process transfer
• Analytical-method transfer
• PACMP
• Troubleshooting
• Knowledge transfer
• Comparability
• Regulatory strategy
• CMO/CDMO collaboration

Contract Manufacturing Organizations

The program explores opportunities and challenges associated with working with:

• CMOs
• CDMOs
• CTOs
• External testing laboratories

Successful external collaboration requires careful control of:

• Technical knowledge
• Quality agreements
• Analytical methods
• Manufacturing changes
• Regulatory responsibilities

Comparability

Comparability remains a central CMC concept whenever manufacturing processes, sites, materials, or delivery systems change.

The program considers how analytical tools can help determine whether pre-change and post-change products remain sufficiently similar in:

• Structure
• Function
• Purity
• Potency
• Stability
• Performance

Accelerated degradation studies may also provide useful supporting information in comparability assessments.

Biopharmaceutical Manufacturing Innovation

Enabling the Future of Biopharmaceutical Manufacturing Through Collaborative Innovation

Riley Myers – NIIMBL

Explores how cross-sector collaboration may advance:

• Manufacturing technology
• Workforce development
• Process innovation
• Regulatory science
• Biopharmaceutical production resilience

Global Manufacturing & Access

The program also addresses expanding biopharmaceutical manufacturing outside traditional production regions.

Sessions examine:

• Local GMP manufacturing
• Technology transfer
• Regulatory capacity
• Vaccine manufacturing
• Quality-testing infrastructure
• Global health preparedness

This broadens the program beyond analytical science to consider how CMC strategy can influence global access to medicines.

Major Topics Covered

• Chemistry, Manufacturing and Controls
• CMC Strategy
• Biopharmaceutical Development
• Biotechnology
• Regulatory Affairs
• Pharmaceutical Quality
• Analytical Development
• Artificial Intelligence
• Machine Learning
• AI in Pharmaceutical Manufacturing
• Predictive Stability
• Accelerated Stability
• ICH Q1
• ICH Q5C
• ICH Q6
• ICH Q14
• ICH M16
• Structured Product Quality Submissions
• Cloud-Based Regulatory Review
• Project PRISM
• Accumulus
• Regulatory Reliance
• Global Regulatory Convergence
• HPLC
• Capillary Electrophoresis
• LC-MS
• Mass Spectrometry
• Peptide Mapping
• Degradation Products
• Process Analytics
• Real-Time Release Testing
• Multispecific Biologics
• Potency Assays
• Reference Standards
• Gene Therapy
• Host Cell Protein
• Host Cell DNA
• mRNA Vaccines
• Vaccine Potency
• Ophthalmic Biologics
• Sub-Visible Particles
• Silicone Oil Droplets
• Visible Particle Control
• Technology Transfer
• PACMP
• CDMO Collaboration
• Comparability
• Advanced Therapy Products
• GMP Manufacturing

Why This Program Is Relevant

Biopharmaceutical CMC has evolved far beyond traditional manufacturing documentation.

Modern product development requires integration of:

Advanced Analytics + Manufacturing Science + Digital Technology + Regulatory Strategy + Patient-Focused Quality

The CASSS CMC Strategy Forum and WCBP are particularly valuable because they create direct scientific dialogue among:

• Pharmaceutical companies
• Biotechnology developers
• Regulatory agencies
• Academic researchers
• Analytical scientists
• Quality specialists

This interaction helps clarify emerging expectations at a time when both therapeutic products and regulatory systems are becoming increasingly complex.

Important Event Structure

The MedicalAmboss title combines two back-to-back CASSS programs:

CMC Strategy Forum North America 2026

January 26, 2026

and

WCBP 2026

January 27–29, 2026

They were presented together through the CASSS event platform but remained distinct scientific programs.

Short Description

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CASSS Sharing Science Solutions CMC Strategy Forum North America WCBP 2026 provides an advanced update on biopharmaceutical CMC, artificial intelligence, machine learning, predictive stability, ICH M16 structured quality submissions, cloud-based regulatory review, advanced analytical characterization, LC-MS, capillary electrophoresis, peptide mapping, multispecific biologics, gene therapy, mRNA vaccines, regulatory reliance, particulate control and silicone-oil risk assessment.

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)