Module 9 2024

03/09/2024

Hurdles when Developing ATMPs

The Organisation for Professionals in Regulatory Affairs

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Technical Obstacles and Uncertainties

Adequate animal models for pre-clinical testing and development

Historically developed in academic environment without the objective of global commercialisation (e.g. cell lines history not complete)

Need for adaptation to reach consistent manufacturing in GMP environment (e.g. raw materials)

Need for specialized facilities (virus handling) and specific technical and scientific skills of manufacturing and testing personnel

Technology transfer and showing comparability highly challenging – strong impact on global development

Cost of goods very high

The Organisation for Professionals in Regulatory Affairs

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