On November 23rd, 2023, the British Pharmacopoeia Commission held a webinar on ATMP Guidance, featuring Clare BLUE, Senior CMC Translation Consultant at eXmoor Pharma, Ryan SMITH, British Pharmacopoeia Specialist at the Medicines and Healthcare products Regulatory Agency, and Lily LI, Lead Scientist of Analytical Development at AviadoBio. Nelia KYSHYNETS, a Senior Researcher from the Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines, participated in this event.
The webinar focused on the British Pharmacopoeia Commission's initiative to produce non-mandatory best practice guidance for analyzing advanced therapy medicinal products (ATMPs). This initiative is a critical step in ensuring regulatory compliance, patient safety, and continued innovation within the industry. Particularly in the rapidly evolving field of biotechnology, such guidance is invaluable in enhancing industry practices.
A key area of discussion was the vector copy number and empty capsid ratio analysis, both of which are vital components in the development of gene therapy. The accuracy of these analyses is paramount for ensuring the safety and efficacy of gene therapies. The best practice guidance provided by the British Pharmacopoeia Commission aims to offer a standardized approach to these analyses, promoting consistency across the industry while simultaneously encouraging innovative practices.
The webinar covered two specific guidance documents: Vector Copy Number and Characterisation of the Vector Particle Population of AAV Products. These documents are instrumental in guiding organizations towards improved research quality and development practices. They also facilitate a collaborative learning environment where organizations can share insights and advancements, further enhancing the overall quality of research and development in the field. Nelia KYSHYNETS' participation in this event underscores her dedication to staying abreast of the latest industry standards and practices.