Accelerating AAV process development: NCSU BTEC

Tuesday 09:00 PDT / 12:00 EDT / 17:00 BST / 18:00 CEST

Sponsor

Accelerating AAV process development: NCSU BTEC

Adeno-associated viruses (AAVs) are widely used vectors for gene therapies, due to their safety and high transduction efficiency. With the increasing demand for faster AAV process development, rapid at-line analytical solutions are essential. Join us for the fourth session of our virtual event, where we explore advanced solutions for AAV process development and characterization.

Customer experience highlight:

Shrarjun Shastry, Scientist at North Carolina State University's Biomanufacturing Training and Education Center (BTEC), emphasizes the importance of analytics in ensuring the quality, safety, and efficacy of AAV vectors in gene therapies. His studies focus on optimizing AAV purification strategies from crude lysates. The PATfix system is employed by BTEC in routine process analytics, offering a comprehensive approach that includes steric exclusion chromatography and size exclusion chromatography for titer analysis, as well as ion exchange chromatography to determine the ratio of empty and full particles. The system's functionality is enhanced by the support of multiple inline detectors, making it a crucial tool in BTEC's analytical processes.

Feature demonstration:

This presentation explores the PATfix system's capabilities for AAV analytics in both upstream and downstream processing, utilizing CIMac analytical columns and various orthogonal methods. The empty/full ratio of AAVs is determined using the AEX-fingerprint method, AAV concentration is measured with the CEX-fingerprint method, and protein impurities are assessed via the SEC-fingerprint method. The AEX-fingerprint method uniquely determines the AAV empty/full ratio from harvest or samples before the capture step, a capability not possible with the other orthogonal methods discussed in the presentation, which require more purified samples for accurate analytics.

Discover the significance of orthogonal analytics for AAV characterization, including the evaluation of empty-full ratios
See how integrated analytical systems with multiple detectors accelerate process development and market delivery of AAV products
Learn how scientists at the BTEC have enhanced their AAV production process, improving accuracy and workflow efficiency, and gaining unique insights
Engage in an interactive Q&A session to get your questions answered and optimize your AAV workflows

This webinar is part of the “Biopharmaceutical analytics unveiled: expert insights and customer success stories” virtual event. To view the other sessions, click on the links below:

Session 1- Enhancing pDNA Production for Gene Therapy: BioNTech

Session 2 - Enhancing mRNA production with advanced analytics: WACKER Biotech

Session 3 - Advancing LNP characterization for drug delivery: NeoVac

Shriarjun Shastry

Scientist II at Biomanufacturing Training and Education Center (BTEC)

Shriarjun Shastry (Arjun), joined the Biomanufacturing Training and Education Center (BTEC) in 2018. Prior to that, he worked in the Process Sciences Investigations Team at Regeneron Pharmaceuticals, Inc. Arjun has expertise in downstream processes and is actively involved in BTEC’s AAV and mRNA process development projects, specifically in purification/downstream processes. He received his bachelor’s degree in biotechnology engineering from BVB College of Engineering and Technology, India, and a Master of Science degree in biopharmaceutical engineering from New Jersey Institute of Technology, Newark. He is also currently pursuing his Part-Time PhD in Chemical Engineering at North Carolina State University.

Blaz Bakalar

Product Manager, PATfix® Platform at Sartorius BIA Separations

Blaz completed his BSc in Biochemistry at the University of Ljubljana, Slovenia, with the program having a heavy focus on laboratory methods widely used in the pharmaceutical industry. He obtained his PhD at NTU Singapore, with a focus on nucleic acid biophysics. In 2020 he joined Sartorius BIA Separations as the PATfix product manager. The PATfix analytical platform combines hardware, software and BIA analytical know-how into a single platform package, making his previous experience a valuable contributor in steering the product towards success.