Expanding the role of ddPCR in AAV gene therapy: from analytical characterization to quality control

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Expanding the role of ddPCR in AAV gene therapy: from analytical characterization to quality control

Live30 webinars pack the latest innovations and applications into a data-rich 30-minute session.

Residual host-cell DNA is a critical process-related impurity in AAV gene therapy manufacturing. Both residual quantity and DNA fragment size affect lot release decisions, yet conventional mass-based assays provide limited information on DNA fragmentation, highlighting the need for sensitive molecular approaches.

This session presents a Droplet Digital PCR (ddPCR)-based strategy to evaluate nuclease-mediated host-cell DNA clearance and fragmentation, using a dual-amplicon 18S rRNA assay targeting 123-bp and 254-bp regions of the same locus. The relationship between the two amplicons derives a fragmentation index, while a single-copy human gene (DCK) provides an orthogonal measure of residual DNA. The approach has been evaluated across a range of nuclease treatment conditions and applied to in-process bioreactor lysate to assess performance in complex manufacturing matrices.

The presentation will also cover the broader application of ddPCR for AAV analytical characterization and quality control, including residual DNA assessment and replication-competent AAV (rcAAV) evaluation in support of GMP-oriented lot release testing.

Attend this webinar to:

Apply a dual-amplicon 18S rRNA ddPCR assay to quantify both residual host-cell DNA and fragment size distribution in a single workflow
Evaluate nuclease-mediated DNA clearance using a fragmentation index derived from paired 123-bp and 254-bp amplicons
Verify residual DNA measurements with an orthogonal single-copy DCK marker tested in complex manufacturing matrices, including bioreactor lysate
Extend ddPCR to wider AAV characterization and GMP lot release testing, including rcAAV evaluation

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The content presented in these sessions is intended for research use only and is not intended for use in diagnostic procedures. The views and opinions expressed in the recordings are those of the individual presenters and do not necessarily reflect the official policy, position, or claims of Bio-Rad Laboratories.

Any clinical applications, test validations, or performance claims discussed are the sole responsibility of the presenting institution or speaker and do not reflect the views or endorsements of Bio-Rad Laboratories.

For Research Use Only. Not for use in diagnostic procedures.

Sharath Babu G.R., PhD

Assistant Principal Investigator | QC Manager at GROW Research Lab, Narayana Nethralaya Foundation

Dr Sharath Babu G R is an Assistant Principal Investigator and QC Manager at the Centre for Genetics and Gene Therapy, GROW Research Laboratory, Bengaluru, with over 17 years of experience in biotechnology research and translational gene therapy. His expertise spans AAV manufacturing and process development, ddPCR-based analytical characterization, host cell DNA quantification, quality control, and CMC for clinical-grade gene therapy vectors, with a focus on inherited retinal and neuromuscular disorders.

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