Immunogenicity of Biologics, Biopharmaceuticals & ATMPs

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Immunogenicity of Biologics, Biopharmaceuticals & ATMPs

online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

The rise of biologics and ATMPs have revolutionized the treatment of many serious diseases. However, the issues of unwanted immunogenicity sometimes remain the key limitation to fully utilize their potential.

Therefore, the development of biologics with decreased immunogenicity risks is of the high importance. This is, however, a very complex and multifactorial challenge, that needs to be addressed in pre-clinical and clinical development.

This unique course provides a practical & in-depth understanding of immunogenicity risk assessment and risk minimization. It also brings clarifications on the latest quality & regulatory requirements for immunogenicity. You will gain insights into analytical assay development as well as into characterization and monitoring of ADAs with appropriate analytical tools.

Join us & take away the strategies to minimize the risks of immunogenicity for your medicinal products.

meet the training leaders
Thorsten Meyer
Executive Consultant
Granzer Regulatory Consulting, Germany
Marion Prior
Deputy Head Business Development
Vela Labs, Austria
DI Markus Roucka
Head Business Development
Tentamus Pharma DACH, Austria
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Immunogenicity of Biologics Biopharmaceuticals & ATMPs online training organized by Fleming_Agenda Cover
Immunogenicity of Biologics Biopharmaceuticals & ATMPs online training organized by Fleming_Agenda Cover
Immunogenicity of Biologics Biopharmaceuticals & ATMPs online training organized by Fleming_Agenda Cover
key training

Topics

Quality & regulatory requirements for immunogenicity

Key considerations for immunogenicity in pre-clinical & clinical stages

Analytics & quality control of immunogenicity

Characterization and monitoring of ADAs with appropriate analytical tools

Study design & bioanalytical methods as characterization tools

Immunogenicity risk assessment, mitigation & risk minimization

Case studies – selected products/examples of immunogenicity for e.g. mAb, ATMPs, biotherapeutics

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