LumaCyte Analytical Method Included in Newly Published ISO Global Standard for Viral Vector Quantification

CHARLOTTESVILLE, Va.--(BUSINESS WIRE)--LumaCyte today announced that its analytical approach has been included in the newly published International Organization for Standardization (ISO) global standard for gene delivery systems, ISO 16921‑2:2026: Biotechnology — Gene delivery systems — Part 2: Quantification methods for viral vectors.

Published earlier this month, the standard establishes requirements and key considerations for quantifying viral vectors, including guidance on method selection, measurement processes, data analysis, and reporting. The inclusion of optical and fluidic force-based measurements, the analytical principle underlying LumaCyte's platform technology, Radiance®, reflects ongoing industry efforts to advance and harmonize viral vector characterization in support of more precise and reproducible gene therapy vector development and manufacturing.

Accurate and precise viral titers are critical in cell & gene therapy and vaccine manufacturing, where dosing, safety margins, and product comparability are tightly linked to reliable vector quantification. In recent years, variability in adeno‑associated virus (AAV) titer measurements, including discrepancies between physical and functional assays, has emerged as a significant challenge, affecting lot release decisions, cross‑site comparability, and commercial supply readiness. As gene therapies move toward larger‑scale manufacturing and broader patient access, the requirement of fit‑for‑purpose, standardized titer measurements has become increasingly urgent.

The ISO 16921 series was developed through a global, consensus‑based process led by ISO Technical Committee 276 (Biotechnology) and addresses long‑standing challenges related to variability in viral vector measurement and reporting. The publication of ISO 16921‑2 comes at a pivotal time for the industry, as sponsors and manufacturers seek greater analytical clarity to support scale‑up, technology transfer, safety and regulatory alignment, particularly for AAV‑based therapies transitioning from clinical to commercial supply.

As a recent example of this ISO‑recognized analytical method in practice, LumaCyte’s Radiance® platform is being used by ATCC in the characterization of its Human Adenovirus Type 5 Reference Material (ATCC VR‑1516™). Advanced measurements support precise quantitation of infectious viral titer, strengthening the consistency and comparability of globally distributed reference materials used across cell and gene therapy and vaccine development. The associated Certificate of Analysis (CoA) is publicly available through ATCC, reinforcing transparency and alignment with the newly published ISO standard.

“Precision in viral vector quantification is foundational to patient safety, product comparability, and a stable supply chain,” said Renée Hart, President & Chief Business Officer of LumaCyte. “The inclusion of optical and fluidic force measurements in this ISO standard reflects the industry’s growing need for standardized, advanced analytics to improve process control, reduce variability, and support confident decision‑making from development through commercial manufacturing.”

ISO 16921‑2:2026 is applicable to a range of viral vectors used in therapeutic development, including adenovirus, vesicular stomatitis virus (VSV), baculovirus, adeno‑associated virus (AAV), lentivirus, and other viral delivery systems, and is intended for use across research, development, and manufacturing stages.

The full ISO standard, ISO 16921‑2:2026: Biotechnology — Gene delivery systems — Part 2: Quantification methods for viral vectors, is available through the ISO website: https://www.iso.org/standard/86188.html

About LumaCyte

LumaCyte is an advanced bioanalytical instrumentation company that delivers quantitative, descriptive, and predictive data insights into cellular systems used in advanced biologics and advanced therapy medicinal product manufacturing. Its platforms enable real time, label free measurement of critical cellular attributes, supporting deeper process understanding and driving consistency, quality, and confidence across therapy development and commercial manufacturing.