Today’s cell-based therapies demand analytics that move as fast as the science itself, yet many laboratories still depend on tools built for a different era. Techniques like flow cytometry, ELISA, and qPCR have long been trusted for measuring critical quality attributes (CQAs) such as purity, potency, and viability. However, these traditional assays all share the same limitation: they rely on fluorescent labels and endpoint measurements, providing only a snapshot of what cells are truly doing. In contrast, process analytical technology (PAT), a framework established by the FDA to promote real-time measurement and control of CQAs, encourages a continuous understanding of biological processes rather than isolated data points. To fully understand the dynamic biology that drives therapeutic performance and meet the demands for more comprehensive PATs, developers need a way to see beyond fluorescence. With a clearer view into real-time cellular behavior, we begin to uncover what traditional methods have been missing all along.
Where Legacy Misses the Mark
Legacy assays provide data about cells, not from them. Flow cytometry, ELISA, and qPCR assays are all dependent on fluorescently labeled antibodies, probes, or dyes for effective read outs. Flow cytometry is capable of single-cell resolution, but labeled antibodies can alter cell behavior, mask subtle phenotypes, or introduce bias into the results. Flow is also constrained by what scientists already know where often novel or unexpected subpopulations often go undetected simply because there isn’t a way to find them, or their importance is not on scientists’ radar.
Molecular methods like ELISA and qPCR are inherently destructive, capturing only a single snapshot in time. Variability in reagents and assay preparation often leads to false positives or negatives, and experimental workflows involve multiple wash steps that can affect reproducibility. Adding further complexity, a combination of multiple endpoint assays like these is needed to build a full cellular profile. The result is a fragmented view of cell function and manufacturability that limits both speed and insight in research and manufacturing environments.
A Label-Free Alternative: Laser Force Cytology
LumaCyte’s Laser Force Cytology (LFC) provides a fundamentally different approach. Instead of labeling or destroying cells, LFC measures the intrinsic biophysical and biochemical properties of individual living cells using laser-based optical forces. Each cell’s physical and optical response generates a multidimensional signature that reflects its functional state, with no dyes, antibodies, or sample manipulation required.
This approach offers several key advantages. It is entirely free of fluorescent labeling, eliminating the cost, time, and variability associated with reagent-based assays. It delivers comprehensive single-cell analysis capable of detecting subtle shifts and emerging subpopulations that other methods overlook. Since measurements are real-time and non-destructive, LFC enables continuous monitoring of critical process parameters (CPPs) and CQAs such as, activation, differentiation, and viability throughout a manufacturing process. Quantitative and reproducible by design, LFC gives scientists direct insight into living cell attributes and changes in behavior, supporting faster decisions across R&D, manufacturing, and quality control.
Enabling Cellular PAT: From Observation to Control
In the broader context of PAT, LFC opens new possibilities for real-time cellular monitoring and control. PAT frameworks are built to ensure product quality by measuring and adjusting CPPs and CQAs as changes are detected. LFC functions as a true cellular PAT, capable of observing functional attributes of cells during culture rather than waiting for endpoint results.
By detecting cell health changes, activation failures, or unwanted differentiation early, LFC helps detect and prevent potential batch failures before they occur. Its immediate feedback loop reduces manufacturers’ reliance on slow, destructive assays, while accelerating process optimization and scale-up. In doing so, it also aligns with regulatory expectations for enhanced process understanding, comparability, and adaptive control, all of which are cornerstones of modern cell and gene therapy manufacturing.
Real-World Impact: Faster Insight Across Modalities
Laser Force Cytology (LFC) is redefining how developers access and act on cellular data—delivering faster, label-free insight that drives real-world impact across gene therapy, vaccine development, and cell therapy manufacturing. By enabling real-time, single-cell analysis without fixation or labeling, LFC accelerates decision-making, reduces assay complexity, and strengthens product quality from early development through commercial production. In gene therapy, LFC supports dynamic tracking of vector transduction, transfection efficiency, and cell health—distinguishing functional from non-functional populations and supporting cell bank qualification to ensure high vector yields and consistent quality. In vaccine production, LFC provides real-time viral titer measurements during culture, enabling accurate dosing, batch consistency, and in-process control that replaces multi-day endpoint assays. In cell therapy manufacturing, LFC detects subtle shifts in viability, differentiation status, and phenotype during expansion, while providing quantitative potency data that support robust release criteria and comparability across lots. By delivering actionable insight earlier in the process, LFC helps developers reduce risk, accelerate timelines, and improve product quality across the development and manufacturing lifecycle.
Across all these modalities, LFC delivers what legacy tools cannot: speed, accuracy, and deeper functional insight. When every hour and every cell count, the ability to analyze living cells directly and act on those insights immediately can make the difference between a successful process and a costly delay.
A Clearer View of Living Cells
Traditional assays will always have a place in biological research and therapy development, but they can no longer keep pace with the complexity of manufacturing today’s living-cell products. The speed and consistency that is needed to get treatments to patients means that the industry can’t afford to wait for the results of multiple release assays to know whether a manufacturing run failed or succeeded. As the industry moves toward real-time, data-driven manufacturing, fluorescent label-based assays are giving way to technologies that can reveal the true behavior of cells as they function, interact, and develop.
LFC offers a clearer view, allowing developers to see their cells as they truly are: alive, dynamic, and growing. By eliminating fluorescent labels and destructive steps, LFC provides the clarity, speed, and control needed for the next generation of cell and gene therapy innovation.
See what’s possible beyond the label. Learn more about Laser Force Cytology™ and how LumaCyte is redefining cell analytics at LumaCyte.com
- Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, manufacturing, and Quality Assurance
- Process Analytical Technologies for Manufacturing Cell and Gene Therapies | BioPharm International
- Seventeen-colour flow cytometry: unravelling the immune system | Nature Reviews Immunology
- Enzyme immunoassay and enzyme-linked immunosorbent assay – PubMed
- The real-time polymerase chain reaction – ScienceDirect
- Rapid quantification of vesicular stomatitis virus in Vero cells using Laser Force Cytology – PubMed
- Rapid In-Process Measurement of Live Virus Vaccine Potency Using Laser Force Cytology: Paving the Way for Rapid Vaccine Development
