JOINT WEBINAR
PathoQuest & Avid Bioservices
Advancing Biomanufacturing 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
Presented by:
Amina Cherif Louazani, PhD, Viral safety and Regulatory affairs Manager at PathoQuest
and
Dave Briggs, Ph.D., Principal Scientist, Late Stage/Commercial at Avid Bioservices
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.
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.
Dave Briggs, Ph.D.
Principal Scientist, Late Stage/Commercial at Avid Bioservices
Dave Briggs, Ph.D., has over 15 years of experience in the biopharmaceutical industry. He holds a Ph.D. in Molecular and Cellular Biology from the University of Arizona. Dave’s expertise spans from small-scale protein purification development to large-scale commercial production and he has contributed to several industry publications and presentations. He began his career at Avid Bioservices as a manufacturing associate and currently oversees Avid Bioservices’ late-stage and process performance qualification (PPQ) activities. He has successfully led six PPQ campaigns, with many more on the horizon. His leadership and technical skills have been crucial in ensuring the successful qualification of biopharmaceutical processes, contributing significantly to customer successes.
