Comparison of 2 emulsion-based digital PCR systems: ddPCR from BioRad vs. dPCR from Stilla, for reliable determination of AAV genome titre

AAV genome titre is a critical parameter for viral vector development and quality control. This application note compares the BioRad QX200 and Stilla Naica digital PCR platforms to assess their ability to generate reliable and comparable AAV genome titre measurements across multiple manufacturing stages.

Both technologies showed consistent performance for purified samples and provided valuable insight into the impact of extraction protocols on quantification results.

KEY HIGHLIGHTS

• BioRad QX200 vs Stilla Naica comparison
• Inter-site assessment including extraction protocol evaluation
• Comparable genome titre results for purified AAV samples
• Evaluation of droplet separation and rain phenomena
• Support for robust AAV analytical workflows

APPLICATIONS

• AAV genome titre determination during process development
• Monitoring manufacturing process stages including harvest, clarification, capture and polishing
• Assessment of full and empty AAV particle enrichment throughout production workflows
• Quantification of viral vector genomes for purified AAV products
• Support for analytical testing associated with clinical and preclinical AAV-based gene therapy products
• Product release testing where reliable genome titre determination is required

ABOUT OXB

OXB is a quality and innovation-led CDMO in cell and gene therapy with over 25 years of experience in manufacturing. They offer end-to-end capabilities, from plasmid design and optimisation to clinical and commercial GMP manufacturing, accompanied by robust control systems, analytical methods and deep regulatory knowledge. They have an expertise, among others, across lentivirus, AAV, and adenoviral vectors and have developed our LentiVector® and inAAVate™ platforms.