Overcoming Regulatory Hurdles In AAV Production

For viral vector production, regulatory agencies like the FDA are placing greater emphasis on the total clearance of residual reagents used during upstream processing. These requirements often introduce significant hurdles, as demonstrating purity is essential for safety and quality assurance. Addressing these challenges requires a shift from reactive compliance to proactive quality control.

This session breaks down the methodologies required to quantify these residuals with high precision, ensuring that quality assurance aligns with current manufacturing rigors. By exploring the integration of tailored assays into existing workflows, technical teams can simplify the documentation process and fortify their compliance strategy. Understanding these analytical advancements is essential for maintaining momentum in viral vector development. Watch the presentation on demand to learn how to bridge the gap between complex production and successful regulatory approval.

Speakers:

Lloyd Achirem, Field Regulatory Specialist, Mirus Bio

Lloyd Achirem is an experienced regulatory affairs professional with a strong foundation in the pharmaceutical and biopharmaceutical sectors, specializing in Chemistry, Manufacturing & Controls (CMC), global regulatory submissions, and regulatory support for ancillary materials used in cell and gene therapy. He has led and supported regulatory strategies aligned with FDA, EMA, and ICH expectations, prepared eCTD Quality Modules, and advised stakeholders on compliance pathways for various submission types. Lloyd’s background includes direct FDA exposure as a Staff Fellow Microbiologist, where he reviewed regulatory submissions, giving him a unique perspective on regulatory requirements and risk-based decision-making. His industry expertise spans regulatory intelligence, quality assurance, and cross-functional collaboration to ensure products meet global standards and withstand regulatory scrutiny.

Miguel Dominguez, Director, Field Applications and Support, Mirus Bio

Miguel Dominguez has a technical background and prides himself in supporting the customer journey from both a technical and customer service perspective. He currently leads the Field Application Scientists, Technical Support Scientists and the Customer Service department. Miguel has overseen various technical and commercial roles at Mirus over the past decade. He and his teams have supported the launch of various products, including the TransIT-X2 Dynamic Delivery System, CHOgro High Yield Expression System, Ingenio EZporator Electroporation System and the VirusGEN RUO and GMP product lines. His experience includes support and management for over 30 distributors in over 40 countries worldwide. Most recently, he has dedicated himself to enhancing the customer experience with his global FAS team, in-house Technical Support team and Customer Service department. His avid desire to support the customer drives his ambition to make Mirus Bio a leader in the cell and gene therapy space. He holds a BS in Genetics from Texas A&M University and an MS in Genetics from the University of Wisconsin.

Mike Molloy, Technical Director, BA Sciences

Mike Molloy has been with BA Sciences since 2012, serving first as the Director of the QC Chemistry laboratory, then heading Analytical Development in Chemistry, then overseeing the Biologics Laboratory, and most recently serving as the Technical Director overseeing the Sample Control and Metrology Groups. Prior to joining BA Sciences, he spent 20 years in pharmaceutical development at Biogen, developing bioassays for product characterization and methods for bioanalysis of clinical trial pharmacokinetics samples. Molloy was head of laboratory operations in the Preclinical and Clinical Development Sciences group at Biogen. Mike holds a Master’s degree in Biology from UMass Lowell in Lowell, Massachusetts, and a Bachelor’s of Science in Biology from the University of New Hampshire in Durham, NH.