Contamination Control Compass
Edition #09/2025

Informative Articles
AAV Gene Therapy Explained: The Critical Role of Accurate QC Testing

Photo: iStock.com/Natali_Mis

Gene therapy is transforming modern medicine – and adeno-associated virus (AAV) vectors are at the heart of this revolution. In our latest blog article, we explore why AAV vectors are so important, and why reliable quality control, especially accurate AAV vector titer testing, is essential for safe and efficacious gene therapies.

At PDA 2025, you will discover how to make quality control of biopharmaceuticals and ATMPs easier in daily practice. Join us to discuss practical solutions for testing mycoplasma, pyrogens, residual DNA, vector copy number, or viral vector titer. Another important topic will be how the new requirements for mycoplasma detection affect your work and how to stay compliant. We look forward to the exchange.

Product Highlights
How Minerva Biolabs sets a new standard in AAV vector titer testing

Among all QC tests, AAV vector titer testing is particularly crucial because it directly influences the dose accuracy of a gene therapy product. Inaccurate titer measurements can result in underdosing or overdosing - reducing therapeutic efficacy or raising safety concerns.

Our ready-to-use MiQuant® AAV kits provide fast and accurate quantification of AAV vector genome titers via digital PCR (dPCR/ddPCRTM), supporting both in-process control and final QC release testing. Tailored kit versions are available for the specific detection of ITR 2/6 (also covering ITR 1, 3, and 7) as well as ITR 5.

Ultra-precise thanks to TruTiter™ technology

The integrated TruTiter™ technology (powered by Promega) ensures that only the DNA packaged within intact AAV capsids is amplified, while free DNA and DNA from broken capsids remain masked and undetectable.

This enables highly precise measurement of AAV vector genome titer and eliminates the need for a DNase treatment step. Unlike DNase, which cannot access DNA enclosed in damaged capsids, TruTiter™ provides superior accuracy and reliability in vector quantification.

Key Benefits

  • High precision: only amplifying DNA in intact capsids

  • Wide dynamic range: 5x103 to 5x106 vp/ml

  • Fast: get results < 3 hours

  • Minimal hands-on time: DNA extraction and standard curve not required thanks to digital PCR technology

  • Device compatibility: suitable for a wide range of dPCR/ddPCR™ platforms

QUICK TIP

Check the neck

Before you open a bottle, look closely at the neck. If you see condensation or residues, they can fall straight into your medium and contaminate it. Taking a few seconds now can save you a lot of trouble later.

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Warm regards,

Your MB Team

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