As cell and gene therapy (CGT) advances, regulatory expectations around product quality and manufacturing rigor continue to rise, especially in viral vector production, such as AAV production. One emerging challenge is the need to demonstrate clearance of residual reagents used during upstream processing, a requirement increasingly emphasized by regulatory agencies like the FDA.
In this webinar, the featured speakers will explore how AAV manufacturers can address this pain point through strategic partnerships and innovations. They’ll introduce a newly developed residual reagent assay designed for use in AAV production workflows. This type of assay helps streamline regulatory submissions and supports quality assurance in viral vector workflows.
Register for this webinar to learn how this assay can support a compliance strategy and hear directly from the experts driving these innovations in AAV production.
Speakers
Mike Molloy, Technical Director, BA Sciences
Mike Molloy has been with Boston Analytical 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 Boston Analytical, 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 Bachelors of Science in Biology from the University of New Hampshire in Durham, NH.
Message Presenter
Miguel Dominguez, Global 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.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in pharma, emerging biotechs and CDMOs, particularly those with roles in:
- Process Development
- Manufacturing Science and Technology (MSAT)
- Manufacturing
- Regulatory
- Quality
What You Will Learn
Attendees will:
- Understand the regulatory landscape and quality expectations for viral vector manufacturing in CGT
- Learn why residual reagent clearance is critical for FDA compliance
- Discover solutions for AAV workflows and how to overcome associated regulatory challenges
- See how assay services can simplify regulatory submissions
Xtalks Partner
BA Sciences
BA Sciences is a cGMP-compliant, FDA/DEA registered, ISO/IEC-17025:2017 certified analytical laboratory located in Salem, NH. We provide testing services to Pharmaceutical and Medical Device companies worldwide. Services include Analytical Testing, Method Development, Microbiological Testing, Environmental Monitoring Services, Protein Chemistry, Stability Testing & ICH-Compliant Storage, Extractables & Leachables Studies, Impurities Testing, mRNA Analysis, Monoclonal Antibody Analytics, Raw Materials Testing and Managed Services & Staffing Augmentation Resources.
BA Sciences prides itself on its culture of delivering unparalleled results. We provide dedicated project managers and technical experts for every project. Our staff is composed of industry professionals who work collaboratively to deliver to your exact requirements. When you start a project with us, you can expect on-time performance as this is a metric we use to drive optimal efficiency. You can count on BA Sciences to utilize our innovative process to deliver quality data according to your specific project demands.
You Must Login To Register for this Free Webinar
Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.
Create Account