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Radiance® Single Cell Analysis Instrument

What is Radiance®?

Every ATMP program carries the same underlying risk: decisions made on incomplete or delayed cellular data ripple forward into failed runs, tech transfer delays, and costly regulatory rework. Radiance® exists to close that gap. It is LumaCyte’s next-generation single-cell analysis instrument, built to give scientists real-time, quantitative insight into individual cell vitality, predictive function, and functional potency, the exact attributes that determine whether a manufacturing run succeeds or fails long before that outcome is visible in downstream assays.

As a cellular Process Analytical Technology (PAT) platform, Radiance® gives development and production scientists something most cell characterization tools cannot: label-free, single-cell measurements of Critical Material Attributes and CPP-sensitive in-process CQA surrogates, delivered in minutes rather than days. That speed matters because it changes when a decision can be made. Instead of learning after the fact that cellular starting material was suboptimal or a process parameter drifted, teams can catch and correct these issues in real time, protecting yield, schedule, and budget. The platform’s multiattribute data also feeds directly into predictive machine-learning models, so the value compounds: each run makes the next one more predictable.

LumaCyte's Radiance Regulatory Assurance graphic

At the core of this capability is Laser Force Cytology™ (LFC), LumaCyte’s proprietary technology that measures the optical and fluidic forces acting on cells in a microfluidic environment. Because LFC is label-free, it detects subtle biochemical and biophysical changes without staining or modifying the cells themselves. For a scientist, this removes a common source of variability and risk: no concern about labels altering cell behavior, no added assay development burden, and no loss of sample to destructive prep. The result is a cleaner, more reliable read on true cell state, usable both in-process and for offline release and potency testing.

LFC’s depth of data is what makes it useful for risk mitigation rather than just monitoring. It generates 20+ parameters per cell simultaneously, capturing internal refractive interfaces, organelle density, mitochondrial content, nuclear material, and nucleus-to-cell ratio. This level of resolution means subtle shifts in cell quality, the kind that typically go undetected until a batch fails release, can be flagged early. Just as important for teams navigating regulatory scrutiny, this is not a novel or unproven method: LFC is commercially available, incorporated into ISO 16921-2 (viral vector quantification) and ISO 8934-1 (cell viability analytical methods), and tested across 50 cell types and 40+ viruses. ATCC’s independent use of LFC for adenovirus global reference standard Certificates of Analysis further establishes it as reference-grade technology, which means adopting Radiance® does not require a scientist to make the case for an unproven method; the validation groundwork is already done.

The ultimate risk in any ATMP program is failing to demonstrate manufacturing consistency to the FDA. Radiance® is built to directly address that risk. By continuously monitoring critical process parameters and product quality attributes, it supports FDA-aligned real-time release strategies and strengthens the potency assurance data sponsors need within their CMC package. For scientists managing tech transfer, this means comparability across clinical and commercial scale is backed by data, not assumption. For program leaders, it means fewer surprises at the regulatory stage, because the process reliability and therapeutic integrity Radiance® documents throughout development are the same data points regulators expect to see at approval.

Key Features

Radiance® offers key features that set it apart from other cell analysis instruments, delivering real-time insights through its proprietary Laser Force Cytology™ technology. These features include:

96-well Plate Format

Radiance® has a 96-well plate format that allows for unattended, automated processing and single cell analysis with a ≤200μL sample volume.

Label‑Free Real‑Time Cellular Insight

Laser Force Cytology™ delivers real‑time, high‑resolution, label-free cellular data that traditional assays often miss, enabling earlier detection of functional changes.

Broad Cell Applicability

Radiance® supports analysis of both adherent and suspension cell types in real time — providing quantitative cellular response insights.

Sensitivity

Laser Force Cytology™ is sensitive to phenotypic changes including: early activation, cell differentiation, viability/vitality, transfection, viral infection, biochemical exposure, etc.

Multivariate Analysis

Radiance® measures 20+ parameters per cell including velocity (optical force), shape, and deformability. Machine learning algorithms leverage this multivariate data to uncover hidden patterns that predict cellular behavior across complex workflows.

Effortless, Benchtop‑Ready Operation

Radiance® combines a compact benchtop footprint with fully label‑free workflows, minimizing hands-on steps and resource demands for streamlined incorporation into laboratory and production workflows.

Technical Specifications

Specification Radiance®
Format 96-well plate
Sample Volume 200 μL per well
Cells per mL 1 million cells
Parameters Measured 20+ per cell (velocity, shape, optical force, deformability, and more)
Sample Prep Time 15 minutes
Resource Level Undergraduate level
Time to Result (TTR) 5 minutes
Cell Types Both adherent and suspension
Instrument Footprint 16″W × 24″D × 29″H (Standard benchtop)
Software Compliance 21 CFR Part 11 (Illuminate™ and ReportR™)

Validated by Science, Recognized by Industry

Radiance® and the Laser Force Cytology™ platform have been validated across peer-reviewed publications, technical studies, and independent industry recognition — demonstrating performance across cell therapy, gene therapy, and vaccine manufacturing applications.

Explore All Publications, Tech Notes, and Resources

Why Radiance® as Your Single Cell Analysis Platform?

Radiance® delivers unbiased, quantitative single-cell analysis that helps developers transform bioprocesses across important cell therapy, gene therapy, biologics, and vaccine manufacturing workflows. By integrating cellular Process Analytical Technology (PAT) capabilities directly into the manufacturing environment, Radiance® enables real-time monitoring and control of critical process parameters — ensuring consistent product quality, accelerated development timelines, and stronger regulatory confidence.

Unlike conventional cell analysis instruments that rely on external labels or subjective interpretation, Radiance® measures each cell’s intrinsic biochemical and biophysical properties in real time. This positions teams to detect process deviations earlier, optimize cell-based potency assay workflows with speed and greater precision, and build the process knowledge necessary to support robust CMC submissions and data packages.

Laser Force Cytology™

Viral Vector Production

Radiance® enables rapid, label‑free quantification of viral infectivity across AAV, lentiviral, and other vector platforms, delivering the accuracy and throughput needed to reduce bottlenecks in process development, formulation, and lot release. Aligned with the global ISO 16921‑2 method, it supports standardized, high‑confidence viral vector characterization.

Cell Vitality & Viability

Unlike standard viability assays, Laser Force Cytology™ measures the physical and mechanical properties of individual cells in real time, detecting subtle shifts in cell state that precede visible loss of viability and directly influence manufacturing outcomes. This capability aligns with the global ISO 8934‑1 method, supporting standardized, high‑confidence assessment of cellular health in advanced bioprocessing.

Cell & Gene Therapy

Radiance® delivers real‑time, label‑free characterization of both autologous and allogeneic CAR‑T and stem cell populations, alongside precise single‑cell monitoring of AAV transfection and transduction. This functional insight strengthens potency assays, enhances process control, and supports regulatory confidence across cell and gene therapy programs.

Biomanufacturing & Cellular PAT Analytics

Radiance® supports next generation biomanufacturing workflows, delivering automated, real‑time monitoring of CMMs, CQAs, and CPP-sensitive in-process CQA surrogates. This supports FDA PAT framework requirements and improving process consistency from upstream culture through lot release.

Vaccines

LumaCyte enables rapid, reproducible viral infectivity testing across vaccine R&D, process development, formulation, and lot release, delivering precise single‑cell viral titers that strengthen cross‑lot and cross‑site comparability. These functional measurements support regulatory expectations for consistent, fit‑for‑purpose potency and neutralization assays.

Advanced Biologics

Radiance® provides predictive insight into cell vitality, function, protein production, and manufacturing performance, enabling improved production yields, faster process optimization, streamlined technology transfer, stronger comparability, and more consistent product quality at commercial scale.

Software Built for Regulated Biomanufacturing Environments

LumaCyte’s Illuminate™ and ReportR™ software suites provide powerful, fully integrated solutions for single cell analysis—engineered specifically for scientists and bioengineers working in regulated environments. Built on the proprietary Laser Force Cytology™ (LFC™) platform, these tools streamline instrument control, data acquisition, and automated analysis to support precision and compliance across biomanufacturing workflows.

The suite includes three core applications—Instrument, Analyzer, and Sampler—each designed to optimize control and workflow efficiency. Illuminate™ is 21 CFR Part 11 compliant, offering secure login management, audit trails, and integration with GMP-aligned processes. ReportR™ is also fully GMP compliant, enabling cloud-based, automated cell analysis and standardized report generation that meets rigorous regulatory standards.

Together, Illuminate™ and ReportR™ power Radiance®’s advanced capabilities, ensuring consistency, accuracy, and operational excellence in both clinical and commercial settings.

Learn More About Illuminate

Frequently Asked Questions About the Radiance® Single Cell Analysis Instrument

What does a label‑free single‑cell analysis instrument let me see?

A label‑free single‑cell analysis instrument measures and characterizes individual cells without dyes or antibodies, revealing true cell‑to‑cell variation instead of averaged bulk signals. Radiance® uses Laser Force Cytology™ (LFC™) to capture each cell’s intrinsic biochemical and biophysical properties, giving new users clearer, more actionable insights for advanced biologics, and ATMP development and biomanufacturing control.

How does Radiance® differ from flow cytometry?

Flow cytometry depends on fluorescent labels, antibodies, and staining protocols to detect and quantify cellular features. Radiance® operates fully label‑free, measuring each cell’s intrinsic optical and biophysical properties in real time. This eliminates reagent variability, reduces sample prep to ~10 minutes, and delivers quantitative, operator‑independent data well‑suited for GMP environments.

What is a cell-based potency assay, and how does Radiance® support it?

A cell‑based potency assay measures the functional biological activity of a therapeutic by evaluating how living cells respond to it — a requirement in FDA guidance for cell and gene therapy products. Unlike marker‑based assays that rely on labels or reporters, Radiance® provides real‑time, quantitative, multivariate data on true cellular function. By capturing intrinsic biochemical and biophysical changes without labels, Radiance® helps developers detect early functional shifts that correlate with therapeutic potency and streamline assay development and in‑process monitoring.

What cell types can Radiance® analyze?

Radiance® has been used across more than 50 cell types to date, spanning the full landscape of advanced biologics, ATMP, and vaccine development. Its label‑free single‑cell measurements work with both adherent and suspension systems — including T cells, NK cells, stem cells, macrophages, HEK293 and other viral‑vector producer lines — as well as a wide range of mammalian cell models used in cell therapy, gene therapy, and vaccine manufacturing.

Is Radiance® designed for use in GMP manufacturing environments?

Yes. Radiance® is built for GMP deployment. Illuminate™ and ReportR™ are both fully 21 CFR Part 11–compliant, providing secure login management, complete audit trails, and GMP‑aligned workflow controls. Together, they deliver operator‑independent data capture and automated, compliant reporting suitable for clinical and commercial manufacturing.

Radiance® itself is designed for ease of use in resource‑constrained environments — requiring minimal hands‑on steps, no labels or antibodies, and workflows that can be run by standard manufacturing and QC personnel without specialized expertise.

Ready to Improve Your Single Cell Analysis?

Whether you are qualifying starting materials, developing cell-based potency assays, or scaling a biomanufacturing process toward commercial release, Radiance® provides the real-time, quantitative single-cell analytics your program requires. With multivariate machine learning at its core, this single cell analysis instrument is built to reduce process variability, strengthen regulatory confidence, and accelerate your path to a consistent, high-quality therapeutic. Connect with our team to explore how Radiance® can support your specific advanced biologic, cell therapy, gene therapy, or vaccine development workflow.

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