Module 9 2024

03/09/2024

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

Preclinical Testing of Biologicals

Dr Alison Wolfreys

Nonclinical Safety Evaluation, UCB Biopharma UK

09 Sept 2024

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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“Biologics” used to include a broader range of modalities… but some now have own guidelines….

Monoclonal antibodies & related formats

This talk will concentrate on mAbs and related formats

Recombinant proteins or

New Biological Entity (NBE)

Synthetic peptides & nucleotides

“natural” peptides

Gene and cell therapy

Vaccines

Gene & cell therapy

The Organisation for Professionals in Regulatory Affairs

Preclinical Testing of Biologicals – Sept 2024

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