Second Global ISO Standard Expands LumaCyte Measurement Framework to Mammalian Cell Viability

CHARLOTTESVILLE, Va.--(BUSINESS WIRE)--A newly released International Organization for Standardization (ISO) global standard for mammalian cell viability brings greater consistency to how cellular state is assessed across biologics and cell therapy. The standard incorporates advanced analytical approaches, including LumaCyte’s optical and fluidic force-based measurement technology

This publication marks LumaCyte’s second inclusion in a global ISO standard this year, following its recognition in ISO 16921-2:2026 for viral vector quantification. While viral vector measurement addresses a critical component of gene delivery systems, mammalian cell viability underpins nearly all biologics and cell-based therapies, making this a broader and more foundational development for the field.

The newly published standard outlines requirements and key considerations for assessing mammalian cell viability, including guidance on method selection, measurement processes, data analysis, and reporting. The inclusion of LumaCyte’s analytical principle reflects increasing recognition of the need for more direct, reproducible, and functionally relevant assessments of cellular state, particularly in advanced therapies where variability in cell quality can affect process consistency, manufacturing performance, and ultimately patient outcomes.

Trypan blue exclusion has been a widely used viability method for years; however, its reliance on membrane integrity as a readout presents inherent limitations. Because membrane integrity is a lagging indicator, early apoptotic cells can retain an intact membrane while already being functionally compromised. As a result, cultures may appear highly viable while containing compromised subpopulations that impact downstream performance, introducing potential uncertainty in process monitoring, comparability assessments, and release decisions.

In contrast, optical and fluidic force-based measurements enable label-free characterization of cell vitality based on intrinsic biochemical and biophysical cellular response metrics and functional properties that directly reflect underlying cell state. This approach supports more consistent and objective evaluation across development and production settings and has demonstrated applicability across a range of cell, gene, and vaccine bioprocess workflows.

Accurate assessment of mammalian cell viability is central to biologics and cell therapy development, where cellular condition directly influences growth, yield, potency, and ultimately patient outcomes. Variability in conventional assays has historically impacted process understanding, lot release decisions, and technology transfer across sites. A global standard for viability introduces a common analytical framework to reduce variability, strengthen comparability, and improve confidence in data used to support regulatory submissions.

“This second ISO inclusion reflects the expanding role of advanced precision analytics in defining how cellular systems are measured and understood,” said Sean Hart, CEO and CSO of LumaCyte. “Cell vitality is a foundational measurement across biologics and cell therapy, and improved insight into cell state has the potential to enhance how these therapies are developed and manufactured.” Recognition within a global standard reinforces the importance of precise, reproducible, and functionally relevant data to support development, manufacturing, and ultimately patient outcomes.

The ISO standard was developed through a global, consensus-based process led by ISO Technical Committee 276 (Biotechnology), with input from industry, regulatory, and academic stakeholders. Its publication comes at a time when increasing therapeutic complexity is driving demand for standardized, robust analytical methods that support scale-up, comparability, and regulatory assurance strategies.

With inclusion now spanning both viral vector quantification and mammalian cell viability, LumaCyte’s analytical approach is helping establish a stronger foundation for how cellular systems are assessed from development through manufacturing. As therapies become more complex, this type of alignment will be increasingly important to support scalable processes, enable efficient technology transfer, and ensure product quality translates reliably to commercial manufacturing, ultimately enabling broader patient access to life-saving therapies.

About LumaCyte

LumaCyte is an advanced bioanalytical instrumentation company that delivers quantitative, descriptive, and predictive data insights into cellular systems used in biologics and advanced therapy 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.