Module 9 2024

03/09/2024

Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products

Immunogenicity Issues

Dr. Isabelle Cludts, Medicines and Healthcare Products Regulatory Agency, UK

09 September 2024

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Learning Outcomes

What is immunogenicity?

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Why / when does it occur?

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• Strategy for immunogenicity assessment

• Screening & confirmatory immunoassays

• Neutralising antibody assays

Issues & considerations

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• Recommendations & Guidelines

The Organisation for Professionals in Regulatory Affairs

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