Immunogenicity of Biologics, Biopharmaceuticals & ATMPs (IMN 2026)

The **Immunogenicity of Biologics, Biopharmaceuticals & ATMPs** training course provides an in-depth exploration of one of the most critical aspects of modern biopharmaceutical development. As biologics, biosimilars, vaccines, monoclonal antibodies, and Advanced Therapy Medicinal Products (ATMPs) become increasingly important in healthcare, understanding and managing immunogenicity is essential for ensuring product safety, efficacy, and regulatory compliance.

This expert-led program focuses on the scientific, analytical, clinical, and regulatory aspects of immunogenicity. Participants will gain a comprehensive understanding of anti-drug antibodies (ADA), immunogenicity risk assessment, assay development, analytical validation, and risk mitigation strategies throughout the product lifecycle. The training will cover key considerations during preclinical and clinical development, including the detection, characterization, and monitoring of immunogenic responses using advanced bioanalytical methods.

Attendees will explore current global regulatory expectations and quality requirements for immunogenicity assessment, including guidance from major health authorities. Through practical examples and industry case studies, participants will learn how to develop effective strategies for minimizing immunogenicity risks in biologics and ATMPs while maintaining product quality and patient safety.

Key areas of discussion include immunogenicity terminology and concepts, ADA screening, confirmation and neutralization assays, analytical assay development, bioanalytical testing strategies, regulatory and quality requirements, immunogenicity risk mitigation, clinical development challenges, safety monitoring, data interpretation, and emerging approaches for risk minimization. Special attention will be given to monoclonal antibodies, biosimilars, recombinant proteins, vaccines, cell therapies, gene therapies, and other advanced biotherapeutic products.

The course combines expert presentations, interactive discussions, case studies, practical recommendations, and question-and-answer sessions to provide participants with actionable knowledge that can be immediately applied within their organizations. Upon completion, attendees will have a stronger understanding of immunogenicity assessment, regulatory compliance, bioanalytical methodologies, and best practices for successful biologics and ATMP development.

This training is highly recommended for professionals working in biotechnology, pharmaceutical development, clinical research, bioanalytical sciences, regulatory affairs, quality assurance, quality control, product development, CRO organizations, and life sciences research who wish to strengthen their expertise in immunogenicity and biologics development.