Speakers:
Blaž Bakalar, Product Manager, PATfix® Platform, Sartorius BIA Separations
Shriarjun Shastry (Arjun), Scientist II, Biomanufacturing Training and Education Center (NCSU BTEC)
Abstract:
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:
Shriarjun 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.
Key Takeaways:
- 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.
