Advancing Cell & Gene Quality Control with GMP Next Generation Sequencing (NGS): Regulatory Insights and Industry Case Study



22nd April 2025 | 10:00am EDT / 7:00am PDT / 3:00pm BST / 4:00pm CEST | | Amina Cherif Louazani, PhD, Viral safety and Regulatory affairs Manager at PathoQuest |BOOK FREE SEAT FOR THIS WEBINAR

This webinar focuses on the established role of GMP-compliant Next Generation Sequencing (NGS) in quality control for cell and gene therapies. With evolving regulatory guidelines addressing advanced therapeutic products, NGS offers a robust and highly sensitive approach to ensure compliance and product safety.

Key topics include an overview of the regulatory landscape, insights into GMP standards for cell and gene therapy products, and a real-world industry case study demonstrating the practical application of NGS. The session will address common challenges, implementation strategies, and best practices for integrating NGS into quality control workflows.

Designed for professionals in quality control, regulatory affairs, and biopharma manufacturing, this session provides valuable guidance on leveraging NGS for enhanced safety in cell and gene therapies.

Presented by Amina Cherif Louazani, PhD, Viral safety and Regulatory affairs Manager at PathoQuest

Amina Cherif Louazani (PharmD, PhD), Viral Safety and Regulatory affairs Manager at PathoQuest, has a strong background in virology and bioinformatics. She holds a PhD in Infectious Diseases from Aix-Marseille University, France, with a specialization in molecular virology and the application of NGS for viral transcriptome analysis. Amina has authored several peer-reviewed articles and held various research and clinical positions. At PathoQuest, she leverages her expertise to conduct expert reviews of viral safety assessments using the iDTECT® platform of NGS assays.

Sponsored by PathoQuest

PathoQuest is a global CRO providing Next Generation Sequencing (NGS)-based Quality Control testing through its iDTECT® assay platform. This platform enables faster, safer and animal free testing for the release of biotherapies to patients. We offer GMP-validated assays for viral safety and genetic characterization of raw materials, cell and gene therapies, monoclonal antibodies and vaccines. Our laboratories in Paris, France, and Wayne, PA, USA, provide global and reliable support to accelerate the availability of biologics. Learn more: https://pathoquest.com/


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