Cell and gene therapies are moving from R&D to the clinic at an unprecedented pace. As the industry scales, manufacturers are challenged with maintaining a consistent level of precision and control over processes involving living cells. Unfortunately, traditional quality control methods, such as those based on batch testing and endpoint assays, only offer snapshots into cell function and often miss variability as it happens.
Radiance, powered by Laser Force Cytology (LFC), changes that paradigm. By delivering fluorescent label-free, single-cell insight into the functional state of living cells, Radiance enables a new generation of cellular Process Analytical Technology (PAT)—giving developers continuous visibility and control across production.
Why Real-Time Cellular PAT Matters
The PAT framework introduced by the FDA encourages manufacturers to build quality into processes rather than testing only the finished product. For living-cell therapies, this means continuously monitoring the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) that define potency, identity, and consistency. Conventional assays struggle to meet this expectation. Batch testing delays detection of deviations, endpoint assays are destructive and slow, and each result captures only a static moment in a dynamic system.
When variability goes unnoticed, yield, potency, and reproducibility can all suffer. Real-time cellular PAT transforms reactive testing into proactive control, helping teams detect shifts in cell health, differentiation, or function early and act before product quality is compromised.
How Radiance® Delivers Real-Time Insight
Radiance applies LumaCyte’s LFC to measure the intrinsic biophysical and biochemical properties of individual cells without fluorescent labels, dyes, or fixation. Each cell’s response to optical forces reveals functional characteristics that define the health and performance of the culture.
CQAs such as potency, differentiation status, viability, and activation can be actively monitored, while CPPs like cell density, metabolic state, and activation kinetics are tracked in real time. Radiance is non-destructive and label-free, therefore, it integrates easily into upstream and downstream workflows, whether during expansion, infection, transduction, or formulation. The result is faster process optimization, earlier deviation detection, and reduced risk of batch failure. Instead of waiting for test results, scientists and therapy manufacturers gain actionable data in real time.
Applications Across Modalities
The advantages of real-time cellular PAT extend across multiple modalities in advanced biomanufacturing. In stem cell workflows, Radiance enables continuous tracking of differentiation trajectories, ensuring cells follow the intended lineage while maintaining potency. Subtle signs of heterogeneity or off-target differentiation can be detected long before they become visible or measurable by conventional assays.
In vaccine development, Radiance provides a dynamic view of immune cell activation and response. Developers can observe activation kinetics in real time and consolidate multiple labeled assays into a single, continuous measurement—simplifying workflows and improving reproducibility.
In cell therapy manufacturing, Radiance delivers quantitative information that supports lot-to-lot consistency. By monitoring potency and phenotype throughout the production cycle, teams can make decisions that maintain CQAs while maximizing yield. Across all these applications, Radiance transforms process monitoring from a retrospective exercise into a continuous, predictive practice, laying the foundation for scalable, reliable manufacturing.
Supporting Regulatory Expectations
Global regulatory agencies are increasingly emphasizing process understanding and real-time control in biologics and advanced therapies. Radiance directly supports these expectations by generating rich, in-process data that demonstrates how CPPs influence CQAs, providing key evidence for a robust control strategy under FDA and EMA guidance.
Real-time cellular PAT also enables adaptive control, allowing manufacturers to intervene before deviations impact quality. Continuous, label-free measurement provides clear documentation of process consistency and control, reinforcing regulatory confidence and accelerating review readiness.
Scaling with Confidence
As advanced therapy manufacturers move toward commercial scale, real-time cellular PAT becomes essential. Traditional batch-based testing can’t keep pace with the dynamic nature of living cells or the expectations of modern regulatory frameworks. Radiance bridges that gap, providing continuous, actionable insight into the cellular drivers of process performance.
With single-cell resolution, label-free operation, and real-time analytics, Radiance helps teams demonstrate true control over processes, building confidence in every run and consistency in every batch.
Discover how Radiance, powered by LFC, can accelerate your process development, improve consistency, and support regulatory compliance at LumaCyte.com
- Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, manufacturing, and Quality Assurance
- Concise Review: Process Development Considerations for Cell Therapy – PMC
- PAT strategies and applications for cell therapy processing – ScienceDirect
- Machine learning and metabolic modelling assisted implementation of a novel process analytical technology in cell and gene therapy manufacturing | Scientific Reports
- The path to PAT: the role of process analytical technologies in advancing CAR-T therapy production
