Advancing Biomanufacturing Quality Control with GMP Next Generation Sequencing (NGS)

Full title: Advancing Biomanufacturing Quality Control with GMP Next Generation Sequencing (NGS): Regulatory Insights and Industry Case Study This webinar focuses on the established role of GMP-compliant Next Generation Sequencing (NGS) in Biomanufacturing Quality Control. 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 BioPharmaceuticals, 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. Amina Cherif Louazani, PhD, Viral safety and Regulatory affairs at PathoQuest, will offer a deep dive into the evolving regulatory landscape for advanced analytical methods, providing clarity on expectations and best practices for implementing NGS in a GMP environment. Complementing the regulatory perspective, Dave Briggs, PhD, Principal Scientist MS&T at Avid Bioservices, will present a compelling industry case study from a leading CDMO, illustrating the real-world application of NGS for product safety, and regulatory compliance. Designed for professionals in quality control, regulatory affairs, and biopharma manufacturing, this session provides valuable guidance on leveraging NGS for enhanced safety in biopharmaceuticals.