CASSS Sharing Science Solutions Bioconjugate Virtual Summit 2026

Bioconjugates • Antibody-Drug Conjugates • CMC • Biopharmaceutical Manufacturing

May 28, 2026 | Virtual Summit | CASSS – Sharing Science Solutions

Explore critical challenges in bioconjugate development, antibody-drug conjugates (ADCs), analytical comparability, impurity control, manufacturing, and CMC strategy with the CASSS Sharing Science Solutions Bioconjugate Virtual Summit 2026.

Scheduled for May 28, 2026, this one-day virtual summit is themed “Tackling Bioconjugate Challenges” and focuses on important technical and regulatory issues encountered by professionals involved in the development, manufacture, characterization, and quality control of bioconjugated therapeutics.

The summit combines targeted speaker presentations with interactive panel discussions addressing areas such as:

• Antibody-drug conjugates
• ADC comparability
• Drug-linker impurities
• Bioconjugate heterogeneity
• Heavy-heavy chain variants
• Charge variants
• Antibody-oligonucleotide conjugates
• Process development
• Analytical characterization
• Late-stage ADC development
• Risk-based comparability
• Chemistry, Manufacturing, and Controls
• Regulatory considerations for ADCs
• Biologics-focused CMC strategy

Course Details

• Program: CASSS Sharing Science Solutions Bioconjugate Virtual Summit 2026
• Organizer: CASSS – Sharing Science Solutions
• Theme: Tackling Bioconjugate Challenges
• Date: May 28, 2026
• Duration: 1 Day
• Format: Virtual Summit
• Primary Focus: Bioconjugates / Antibody-Drug Conjugates
• Scientific Focus: Analytical Comparability / Impurity Control / Manufacturing / CMC
• Professional Areas: Biopharmaceutical Development / Quality Control / Regulatory Science
• Language: English

Summit Overview

Bioconjugated therapeutics combine biologic molecules with additional functional components and can present important challenges during development, characterization, manufacturing, and regulatory assessment.

The CASSS Bioconjugate Virtual Summit 2026 focuses on these challenges through a specialized program addressing both technical and regulatory considerations.

Particular emphasis is placed on:

• Comparability risks
• Low-level product variants
• Drug-linker impurities
• Impurity qualification
• Bioconjugate heterogeneity
• Charge variants
• Antibody-oligonucleotide conjugates
• Manufacturing process development
• Late-phase development
• Analytical comparability
• CMC requirements

The program can be summarized as:

Molecular Characterization → Process Development → Impurity Control → Comparability → CMC & Regulatory Strategy

Learning Objectives

Upon completion of the summit, participants should be better able to:

• Identify and mitigate comparability risks, such as detecting new low-level heavy-heavy chain variants in Antibody-Drug Conjugates (ADCs).
• Evaluate impurity qualification requirements specifically for drug-linkers and their related impurities used to generate ADCs.
• Develop and characterize manufacturing processes for antibody-oligonucleotide conjugates.
• Manage bioconjugate heterogeneity related to drug-linkers and formulate charge variant control strategies for late-stage ADCs.
• Design risk-based analytical comparability strategies for ADCs navigating late-phase development.
• Apply Chemistry, Manufacturing, and Controls (CMC) regulatory considerations for ADCs from a strict biologics perspective.

BIOCONJUGATES

Bioconjugate Development Challenges

The summit is centered on the theme “Tackling Bioconjugate Challenges.”

Bioconjugate development requires careful control of product characteristics throughout development and manufacturing.

The program focuses particularly on challenges related to:

• Product heterogeneity
• Impurities
• Conjugation-related variants
• Manufacturing consistency
• Analytical comparability
• Late-stage development
• Regulatory expectations

ANTIBODY-DRUG CONJUGATES

ADC Development

Antibody-drug conjugates (ADCs) are a major focus of the summit.

The program examines analytical, manufacturing, and regulatory questions associated with ADC development, including:

• Product variants
• Drug-linker impurities
• Comparability
• Charge variants
• Late-phase development
• CMC strategy

ADC COMPARABILITY

Comparability Risk Assessment

The summit addresses how developers can identify and mitigate risks during ADC comparability assessments.

A key example included within the learning objectives is detection of:

New low-level heavy-heavy chain variants

that may emerge during development or manufacturing changes.

HEAVY-HEAVY CHAIN VARIANTS

Low-level product variants may create challenges when evaluating whether manufacturing or process changes have altered an ADC product.

The curriculum includes consideration of:

• Detection
• Characterization
• Comparability implications
• Risk assessment

for heavy-heavy chain variants.

RISK-BASED ANALYTICAL COMPARABILITY

Late-Phase ADC Development

The summit includes development of risk-based analytical comparability strategies for ADCs progressing through late-phase development.

A structured comparability approach may require attention to:

• Product quality attributes
• New variants
• Impurities
• Manufacturing changes
• Analytical sensitivity
• Development stage

The overall framework can be considered as:

Identify Change → Assess Risk → Characterize Product → Compare Attributes → Evaluate Impact

DRUG-LINKER IMPURITIES

Impurity Qualification

Drug-linkers and their associated impurities represent an important component of ADC development.

The program addresses impurity qualification requirements specifically for:

• Drug-linkers
• Drug-linker-related impurities
• Materials used in ADC generation

This provides a focused discussion around impurity control within the bioconjugate manufacturing process.

IMPURITY CONTROL

Impurity management is one of the major themes of the summit.

The program emphasizes understanding:

• Impurity sources
• Qualification requirements
• Analytical detection
• Product impact
• Manufacturing controls

within the context of bioconjugated therapeutics.

BIOCONJUGATE HETEROGENEITY

Product Heterogeneity

Bioconjugation can generate heterogeneous molecular populations.

The summit reviews management of bioconjugate heterogeneity, particularly heterogeneity associated with:

• Drug-linkers
• Conjugation processes
• Charge variants

Understanding and controlling heterogeneity is an important part of product characterization and quality strategy.

CHARGE VARIANTS

Late-Stage ADC Control Strategies

The program includes development of charge variant control strategies for late-stage ADCs.

This topic connects analytical characterization with practical product-control strategies as development progresses.

ANTIBODY-OLIGONUCLEOTIDE CONJUGATES

Manufacturing Process Development

The summit extends beyond traditional ADCs to include antibody-oligonucleotide conjugates.

Participants review development and characterization of manufacturing processes for these complex bioconjugated molecules.

The workflow includes:

Process Development → Conjugation → Characterization → Control Strategy

MANUFACTURING PROCESS CHARACTERIZATION

A robust bioconjugate development program requires understanding how manufacturing processes influence the final product.

The summit addresses:

• Process development
• Process characterization
• Product heterogeneity
• Impurity generation
• Analytical monitoring
• Product consistency

LATE-PHASE DEVELOPMENT

As ADC programs progress toward later stages of development, analytical and manufacturing strategies may require increased control and justification.

The summit addresses late-phase questions involving:

• Comparability
• Charge variants
• Impurities
• Risk assessment
• Product characterization
• Regulatory strategy

CHEMISTRY, MANUFACTURING & CONTROLS – CMC

CMC Strategy for ADCs

Chemistry, Manufacturing, and Controls (CMC) is a major regulatory focus of the program.

The curriculum reviews ADC CMC considerations from a strict biologics perspective.

Important areas include:

• Product characterization
• Process understanding
• Manufacturing controls
• Analytical comparability
• Impurity control
• Product quality
• Regulatory documentation

BIOLOGICS REGULATORY PERSPECTIVE

The summit considers ADCs within the regulatory framework used for biologic products.

This perspective requires careful evaluation of:

• Molecular characteristics
• Process-related changes
• Quality attributes
• Impurities
• Comparability
• Manufacturing controls

ANALYTICAL CHARACTERIZATION

Analytical science plays a central role in bioconjugate development.

The program addresses analytical approaches supporting:

• Detection of low-level variants
• Comparability
• Impurity characterization
• Charge variant assessment
• Process characterization
• Late-stage development

Cross-Functional Development Focus

Analytical Science + Manufacturing

Analytical methods help determine whether changes in manufacturing influence product quality.

Important connections include:

• Process changes
• Molecular variants
• Impurities
• Product heterogeneity
• Comparability

Manufacturing + CMC

Manufacturing strategy and CMC development are closely linked.

Process characterization supports regulatory understanding of:

• Product consistency
• Critical quality characteristics
• Impurity control
• Manufacturing robustness

Bioconjugation + Regulatory Science

Bioconjugated therapeutics create regulatory questions that require integration of:

• Biologics knowledge
• Conjugation chemistry
• Analytical characterization
• Manufacturing science
• Quality-control strategy

Major ADC Topics

• Antibody-Drug Conjugates
• ADC Development
• ADC Comparability
• Late-Phase ADC Development
• Heavy-Heavy Chain Variants
• Charge Variants
• Drug-Linker Impurities
• Analytical Comparability
• Risk-Based Comparability
• CMC for ADCs

Major Bioconjugate Topics

• Bioconjugates
• Bioconjugate Development
• Bioconjugate Heterogeneity
• Drug-Linker Heterogeneity
• Conjugation Processes
• Product Characterization
• Process Characterization
• Impurity Control
• Quality Strategy

Major Manufacturing Topics

• Manufacturing Process Development
• Process Characterization
• Antibody-Oligonucleotide Conjugates
• Process Control
• Product Consistency
• Late-Stage Manufacturing
• Biopharmaceutical Manufacturing

Major Analytical Topics

• Analytical Characterization
• Comparability Assessment
• Variant Detection
• Heavy-Heavy Chain Variants
• Charge Variant Analysis
• Impurity Qualification
• Risk-Based Analytical Strategy
• Product Quality Attributes

Major Regulatory & CMC Topics

• Chemistry, Manufacturing, and Controls
• CMC
• ADC Regulatory Strategy
• Biologics Perspective
• Impurity Qualification
• Comparability
• Product Quality
• Regulatory Considerations

Who Should Take This Summit?

The CASSS Sharing Science Solutions Bioconjugate Virtual Summit 2026 is designed for industry, regulatory, and academic professionals involved in the development, manufacturing, characterization, and quality control of biopharmaceutical products, with a particular focus on bioconjugates and antibody-drug conjugates.

It is especially relevant for:

• Pharmacologists
• Immunologists
• Oncologists
• Biochemical Engineers
• Biopharmaceutical Scientists
• Analytical Scientists
• Process Development Scientists
• Manufacturing Scientists
• CMC Professionals
• Quality-Control Professionals
• Regulatory Professionals
• Bioconjugate Developers
• ADC Development Teams
• Academic Researchers working with bioconjugates

Why This Summit Is Useful

CASSS Sharing Science Solutions Bioconjugate Virtual Summit 2026 provides a focused examination of technical and regulatory challenges associated with modern bioconjugated therapeutics.

The summit can help participants review:

• ADC comparability risks
• Heavy-heavy chain variants
• Drug-linker impurities
• Impurity qualification
• Bioconjugate heterogeneity
• Charge variant control
• Antibody-oligonucleotide conjugates
• Manufacturing process development
• Process characterization
• Late-phase ADC development
• Risk-based analytical comparability
• CMC regulatory strategy
• Biologics-focused regulatory considerations

The curriculum can be summarized as:

Bioconjugate Design → Manufacturing → Characterization → Impurity Control → Comparability → CMC

within a practical biopharmaceutical development and quality framework.

Product Information

• Product: CASSS Sharing Science Solutions Bioconjugate Virtual Summit 2026
• Organizer: CASSS – Sharing Science Solutions
• Theme: Tackling Bioconjugate Challenges
• Date: May 28, 2026
• Duration: 1 Day
• Format: Virtual Summit
• Primary Focus: Bioconjugates / Antibody-Drug Conjugates
• Scientific Areas: Analytical Comparability / Impurity Control / Manufacturing / CMC
• Professional Areas: Biopharmaceutical Development / Regulatory Science / Quality Control
• Available From: MedicalAmboss.com

Short Description

CASSS Sharing Science Solutions Bioconjugate Virtual Summit 2026 is a one-day virtual program focused on the technical, analytical, manufacturing, and regulatory challenges associated with bioconjugates and antibody-drug conjugates (ADCs).

The summit covers ADC comparability, heavy-heavy chain variants, drug-linker impurities, impurity qualification, antibody-oligonucleotide conjugates, bioconjugate heterogeneity, charge variants, late-stage ADC development, risk-based analytical comparability, manufacturing process characterization, and CMC regulatory considerations.

You will find it on MedicalAmboss.com.

Topics

• Antibody-Drug Conjugates: Development and characterization challenges associated with ADC products.
• ADC Comparability: Assessment of product comparability during development and manufacturing changes.
• Heavy-Heavy Chain Variants: Detection and risk assessment of new low-level heavy-heavy chain variants.
• Comparability Risk Management: Identification and mitigation of analytical and product-quality comparability risks.
• Drug-Linker Impurities: Qualification requirements for drug-linkers and related impurities used in ADC generation.
• Impurity Qualification: Analytical and regulatory considerations related to bioconjugate impurities.
• Antibody-Oligonucleotide Conjugates: Development and characterization of manufacturing processes for antibody-oligonucleotide conjugates.
• Manufacturing Process Development: Design and characterization of bioconjugate manufacturing processes.
• Bioconjugate Heterogeneity: Management of heterogeneity arising from drug-linkers and conjugation.
• Charge Variants: Control strategies for charge variants in late-stage ADC development.
• Late-Phase ADC Development: Analytical and manufacturing challenges encountered during advanced development.
• Risk-Based Analytical Comparability: Design of analytical strategies based on product and process risk.
• Analytical Characterization: Characterization of variants, impurities, heterogeneity, and product changes.
• CMC: Chemistry, Manufacturing, and Controls requirements relevant to ADCs.
• Biologics Regulatory Perspective: CMC and regulatory considerations for ADC products viewed from a biologics framework.
• Biopharmaceutical Quality: Product quality, manufacturing consistency, analytical control, and regulatory strategy.

• Analytical Comparability Approach for an Antibody Drug Conjugate

• Charge Variant Control Strategy for Late-Stage Antibody Drug Conjugates

• CMC Regulatory Considerations for Antibody-Drug Conjugates (ADCs) – From the Biologics Perspective

• Comparability Risk Mitigation Identification of a New Low-Level Heavy-Heavy Chain Variant in an ADC

• Designing Risk-Based Analytical Comparability Strategic Considerations for Antibody Drug Conjugates in Late-Phase Development

• Development and Characterization of Antibody-Oligonucleotides Conjugate Manufacturing Processes

• Impurity Qualification Requirements for Drug-Linkers Related Impurities Used to Generate Antibody-Drug Conjugates

• Managing Bioconjugate Heterogeneity Related to Drug-Linkers

• Session I Panel Discussion and Summary Closing Remarks

• Session II Panel Discussion and Summary Concluding Remarks