British Pharmacopoeia’s ATMP Guidance

Presented by

Clare Blue at Biogen, Ryan Smith, and Lily Li, Lead Scientist, Analytical Development at AviadoBio

About this talk

Presented by Clare Blue, Senior CMC Translation Consultant eXmoor Pharma, Ryan Smith, British Pharmacopoeia Specialist at Medicines and Healthcare products Regulatory Agency and Lily Li, Lead Scientist, Analytical Development at AviadoBio The British Pharmacopoeia Commission is producing non-mandatory best practice guidance for analysing advanced therapy medicinal products (ATMPs). This guidance ensures regulatory compliance, patient safety, and industry innovation. Non-mandatory best practice guidance can enhance industry practices, especially in technical fields such as biotech. Vector copy number and empty capsid ratio analysis are crucial in gene therapy development, and accurate analysis is essential for safety and efficacy. Best practice guidance can provide a standardised approach for consistency and encourage innovation. Organisations can learn from each other and improve the quality of research and development. The webinar will cover two guidance documents: Vector Copy Number and Characterisation of the Vector Particle Population of AAV Products.
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