Frequently Asked Questions

Explore answers to the most common questions about LumaCyte’s Laser Force Cytology™ (LFC) technology, the Radiance® platform, and how label-free single-cell analysis supports advanced biologics, cell therapy, gene therapy, viral vector, vaccine, and biomanufacturing programs. Browse by category below, or speak to an expert if you don’t see your question answered here.

General Questions | Laser Force Cytology™ Application Questions | Radiance® Instrument & Software Questions

General Questions

How is Laser Force Cytology™ (LFC™) different from traditional flow cytometry?

Traditional flow cytometry relies on fluorescent dyes, antibodies, or genetic reporters to identify cellular characteristics. Laser Force Cytology™ (LFC™) takes a different approach by measuring how cells naturally respond to optical forces, without labels or cell modification. This allows scientists to study cells in their native state while eliminating the time, expense, and potential biological impact associated with labeling.

With as little as 10 minutes of sample preparation and rapid time-to-results, LFC enables near real-time cellular insights that can be incorporated directly into development and manufacturing workflows. As a cellular Process Analytical Technology (PAT), Radiance® provides continuous visibility into cellular fitness, vitality, functional potency, infectivity, transfection efficiency, and other critical biological attributes as processes unfold.

By delivering functionally relevant, label-free measurements at the single-cell level, Radiance helps organizations identify variability earlier, optimize processes faster, strengthen process control, and make more informed decisions throughout the product lifecycle. The result is a deeper understanding of cellular quality and performance, reduced development and manufacturing risk, and greater confidence that products will consistently achieve their intended outcomes.

This shift toward measuring biological function directly is becoming increasingly important across advanced therapeutics and biomanufacturing. Regulators, standards organizations, and industry leaders are placing greater emphasis on functionally relevant measurements that demonstrate how cells perform, rather than relying solely on surrogate markers that may not fully predict biological outcomes. By providing direct insight into cellular fitness, vitality, and functional response, LFC helps organizations build a stronger understanding of product potency, process performance, and quality attributes, supporting the development of safer, more effective therapies and more robust manufacturing processes.

What is label-free cell analysis and why does it matter?

Label-free analysis measures cells in their natural state, without fluorescent dyes, antibodies, stains, or genetic modification. Rather than relying on externally introduced markers, it captures intrinsic cellular responses directly, providing a more complete picture of cellular health, fitness, function, and biological performance.

Because cells remain unaltered, researchers and manufacturers can observe biologically meaningful changes that may be masked, distorted, or overlooked when labels are used. This deeper understanding can help identify subtle differences in cell populations, monitor responses to process conditions, evaluate potency, and detect emerging variability earlier in development and manufacturing.

As advanced therapies and biologics become increasingly complex, there is growing industry and regulatory emphasis on functionally relevant measurements that demonstrate how cells actually perform, rather than relying solely on surrogate markers. Label-free analytics help address this need by providing direct insight into cellular behavior and biological activity, supporting better process understanding, more informed decision making, and greater confidence in product quality, consistency, and therapeutic performance.

Ultimately, label-free analysis helps organizations move beyond simply asking whether a cell possesses a particular marker and toward understanding whether that cell is healthy, functional, and capable of delivering the desired biological outcome.

What industries and therapeutic areas does LumaCyte serve?

LumaCyte supports organizations developing and manufacturing biologics, cell therapies, gene therapies, viral vectors, vaccines, regenerative medicines, and other advanced therapeutics. Our customers range from emerging biotechnology companies to global pharmaceutical manufacturers, all working to better understand the health, quality, and functionality of living cells. By providing real-time cellular insights, LumaCyte helps teams accelerate development, improve manufacturing consistency, and gain greater confidence in their products and processes.

Does LumaCyte offer training on its instruments and technology?

Absolutely. Every new customer is supported through the LFC Academy and receives hands-on, on-site training from our PhD-level scientists during instrument installation. New instrument purchases also include three months of dedicated method development, application support, and data analysis assistance, helping teams quickly move from initial onboarding to meaningful biological insights.

Our goal is not simply to train users on an instrument, but to help customers confidently incorporate Radiance® into their development and manufacturing workflows. Whether you are building a new potency assay, implementing a cellular PAT strategy, characterizing stem cell populations, assessing donor variability, or optimizing a manufacturing process, our scientific team works alongside you to help accelerate success.

At LumaCyte, we view every customer relationship as a long-term partnership. We are committed to helping organizations maximize the value of their investment, expand into new applications, and generate the insights needed to make better decisions, reduce risk, and achieve more consistent outcomes throughout the product lifecycle.

How do I request pricing or a quote for Radiance®?

We would love to learn more about your program, scientific goals, and analytical challenges. Simply request a quote or contact our team, and we will work with you to understand your application, workflow, and development or manufacturing objectives.

Because every organization is different, we take a consultative approach to ensure you receive the right combination of instrumentation, scientific support, training, and analytical resources to maximize success. Whether you are evaluating donor material, developing potency assays, optimizing manufacturing processes, implementing a cellular PAT strategy, or expanding across multiple sites, our team can help identify the most effective solution for your needs.

Many customers begin with a specific challenge and discover opportunities to apply Radiance® across multiple programs, modalities, and workflows. Multi-unit pricing programs are available for organizations deploying Radiance across multiple laboratories, development groups, or manufacturing locations, helping teams establish a consistent analytical framework throughout the product lifecycle.

Who do I contact for technical support on my Radiance® instrument?

Our scientific and technical support team is always available to help you get the most from your Radiance® platform. Whether you have questions about a new application, data interpretation, software features, instrument operation, service needs, or best practices, we are here to support you. Customers can reach us through the Support page, by phone, text, or email.

At LumaCyte, we view support as an extension of our partnership with every customer. Our team includes experts who understand both the technology and the biology behind your work, allowing us to provide practical guidance that helps you move projects forward with confidence. From onboarding and method development to ongoing optimization and scientific consultation, we are committed to helping you generate meaningful insights and achieve successful outcomes.

Where can I find published research validating LumaCyte’s technology?

Laser Force Cytology™ is supported by more than 50 peer-reviewed publications spanning cell therapy, gene therapy, vaccines, virology, stem cell research, and bioprocessing applications. In addition to extensive publication support, LumaCyte’s optical and fluidic force measurement methods were incorporated into two global ISO biotechnology standards published in 2026, reflecting growing industry recognition of the importance of functionally relevant cellular measurements.

Together, these scientific publications, industry collaborations, and international standards help demonstrate the robustness, reproducibility, and real-world applicability of LumaCyte’s technology across a wide range of advanced biomanufacturing workflows.

Laser Force Cytology™ Applications

What applications does the Radiance® platform support?

Radiance® supports a broad range of applications across biologics, advanced therapy medicinal products (ATMPs), cell therapy, gene therapy, stem cell therapies, viral vector production, vaccines, regenerative medicine, and emerging cellular therapies. To date, the technology has been successfully applied across more than 50 cell lines and 40 viruses, demonstrating broad utility across both research and manufacturing environments.

From donor qualification and cell bank characterization to process development, manufacturing optimization, potency assessment, comparability studies, and quality-related investigations, Radiance helps organizations better understand the biological performance of their products and processes. The platform has been used to evaluate cell fitness and functional potency in CAR-T and other cell therapies, monitor differentiation and developmental state transitions in stem cell programs, assess transfection and transduction efficiency in gene therapy workflows, quantify viral infectivity and potency for vaccines and viral vectors, and characterize cellular responses that influence biologics manufacturing performance.

Because Radiance measures cellular responses directly rather than relying solely on endpoint measurements or surrogate markers, it provides deeper insight into cell vitality, functional fitness, potency, infectivity, and other critical biological attributes. Many customers find they can deploy the same platform across multiple programs, unit operations, and development stages, creating a consistent analytical framework from research through commercial manufacturing.

The result is stronger process understanding, earlier identification of variability, improved manufacturing consistency, more predictive decision making, and greater confidence that products will perform as intended while helping accelerate the delivery of safer, more effective therapies to patients.

How does LumaCyte support vaccine development?

LumaCyte helps vaccine developers rapidly measure viral infectivity, potency, neutralization activity, and cellular responses using real-time, label-free analytics. By directly monitoring how cells respond to viral infection, researchers gain earlier insight into biological activity across vaccine discovery, process development, manufacturing, formulation studies, scale-up, and lot release testing.

Traditional infectivity, potency, and neutralization assays often require days or even weeks to generate results, which can slow development timelines and delay critical decisions. Radiance® provides quantitative, functionally relevant data in hours rather than relying on lengthy endpoint assays, enabling teams to evaluate candidate vaccine constructs more quickly, optimize manufacturing processes, compare formulations, and assess the impact of process changes with far greater speed.

Because Radiance measures cellular responses directly, it can reveal meaningful differences in viral performance and biological activity that may not be apparent through traditional titer or viability measurements alone. These insights help organizations build a deeper understanding of the relationship between infectivity, potency, and product quality while improving process control and manufacturing consistency.

The result is faster development cycles, more informed decision making, stronger process understanding, and greater confidence in product performance. By enabling earlier detection of variability and more biologically relevant assessments of infectivity and potency, Radiance helps organizations accelerate the development and manufacture of safer, more effective vaccines while reducing the risk, cost, and delays associated with traditional testing approaches.

What are potency assays and how does Radiance measure them?

Potency assays are designed to demonstrate that a biological product can perform its intended function. They are among the most important analytical methods used across vaccines, cell therapies, gene therapies, stem cell therapies, viral vectors, biologics, and other advanced therapeutic products because they help establish the relationship between product quality and biological performance.

Traditional potency assays often rely on surrogate markers, endpoint measurements, or lengthy functional studies that can require days or even weeks to generate results. Radiance® takes a different approach by measuring cellular responses directly and in near real time using label-free Laser Force Cytology™ technology. Rather than focusing solely on whether a biological interaction occurred, Radiance helps quantify how cells respond to that interaction and how those responses relate to product functionality.

For vaccines and viral vectors, Radiance can measure cellular responses to infection and infectivity, generating rapid functional potency insights that support development, manufacturing, and lot characterization. For cell and gene therapies, the platform can be used to evaluate cellular activation, transduction, functional fitness, and biological performance, helping developers better understand potency while monitoring manufacturing consistency. In stem cell applications, Radiance can monitor differentiation, maturation, and developmental state transitions to help assess whether cells are progressing toward the desired therapeutic phenotype. For biologics and protein-based therapeutics, Radiance can help characterize cellular responses to process conditions and manufacturing changes that may ultimately impact product performance.

Because LumaCyte’s LFC analytics generates quantitative, single-cell measurements in minutes rather than days, teams gain earlier visibility into biological function and emerging process variability. This enables faster decision making, supports the development of more predictive potency assays, strengthens comparability and process characterization studies, and provides greater confidence that products will perform as intended. By measuring cellular fitness, vitality, and functional response directly, Radiance helps organizations move beyond surrogate measurements toward a more biologically relevant understanding of potency across the entire product lifecycle.

What is a neutralization assay in vaccine development?

A neutralization assay measures how effectively antibodies generated by a vaccine, prior infection, or therapeutic intervention prevent a virus from infecting target cells. Because neutralizing antibodies are often closely associated with protective immunity, these assays play a critical role in vaccine development, potency assessment, immunogenicity studies, and evaluation of therapeutic antibodies.

Radiance® enables researchers to measure the cellular consequences of viral infection and neutralization in a rapid, label-free manner, providing quantitative insights into biological activity much earlier than traditional plaque-based or endpoint assays. By directly measuring how cells respond to viral infection, teams can quickly determine whether antibodies are successfully preventing infection and assess the relative strength of that response.

This accelerated feedback helps vaccine developers compare candidate formulations, evaluate immune responses, characterize therapeutic antibodies, and make critical development decisions sooner. Faster access to biologically relevant data can shorten study timelines, increase laboratory throughput, reduce reliance on labor-intensive assays, and provide a clearer understanding of both neutralizing activity and functional potency. The result is greater confidence in vaccine and therapeutic performance while enabling faster progression through development and manufacturing workflows.

Can Laser Force Cytology™ be used for oncolytic virus research?

Absolutely. Laser Force Cytology™ (LFC™) is well suited for oncolytic virus research because it measures how both cancer cells and viruses interact in real time without the need for labels, stains, reporters, or genetic modification. By monitoring cellular responses directly, researchers can observe infection kinetics, characterize phenotypic changes in tumor cells, and gain a deeper understanding of viral activity throughout the infection process.

For oncolytic virus developers, this provides valuable insight into viral infectivity, therapeutic potency, and mechanism of action. Rather than waiting days or weeks for endpoint assays, Radiance® can detect cellular responses much earlier, enabling faster assessment of candidate viruses, process conditions, and manufacturing changes. Researchers can compare viral constructs, evaluate dose-response relationships, and better understand how effectively a given virus is interacting with and impacting target cancer cells.

Radiance can also support process development and manufacturing efforts by providing rapid, quantitative measurements that help teams monitor product consistency and biological performance throughout development. Because the technology generates functionally relevant cellular data at the single-cell level, it can reveal important differences in viral activity and therapeutic response that may not be captured through conventional infectivity or viability measurements alone.

Ultimately, LFC helps organizations move beyond simply confirming that infection occurred. It provides a deeper understanding of how cells respond to infection, how viral activity relates to potency, and how those biological responses may translate to therapeutic performance. This can accelerate development, strengthen potency strategies, reduce development risk, and increase confidence in both product characterization and manufacturing decisions.

How does Radiance® support viral vector production (AAV, lentiviral, and other vector systems)?

Successful viral vector manufacturing begins with the cells themselves. Radiance® helps teams qualify and characterize master and working cell banks by providing label-free insights into cellular fitness, consistency, and functional readiness before those cells are used in production processes.

From there, Radiance enables rapid, label-free measurement of viral infectivity across AAV, lentiviral, and other vector platforms used in gene therapy and advanced therapeutics. By directly quantifying cellular responses to viral infection, the technology provides functional insights that help developers and manufacturers better understand vector quality, process performance, and product consistency throughout development and manufacturing.

Importantly, LumaCyte’s optical and fluidic force measurement methods were incorporated into the ISO 16921-2 international standard, providing a globally recognized framework for standardized viral vector characterization. This gives organizations confidence that the data they generate are not only fast and biologically relevant, but also aligned with internationally recognized best practices for viral vector analytics.

What role does Laser Force Cytology™ (LFC™) play in cell and gene therapy manufacturing?

Cell and gene therapy manufacturing depends on understanding the health, fitness, functionality, and consistency of living cells throughout the entire process, from donor qualification and starting material assessment to final product release. Laser Force Cytology™ (LFC™) provides real-time, label-free characterization of both autologous and allogeneic cell populations, generating biologically meaningful insights that help manufacturers better understand and control their processes.

Radiance® can be used to qualify donor material and incoming cell populations, identify variability before it propagates downstream, monitor critical manufacturing steps such as activation, expansion, transfection, and transduction, and support the development of more predictive potency and characterization assays. By measuring functional cellular responses directly, LFC helps reveal differences in cellular fitness, activation state, and biological performance that may not be apparent through traditional marker-based methods alone.

As a cellular Process Analytical Technology (PAT), Radiance provides early visibility into process performance and emerging deviations, enabling teams to make informed decisions before issues impact yield, product quality, or manufacturing timelines. These insights can improve process understanding, strengthen comparability strategies, support scale-up and technology transfer, reduce batch-to-batch variability, and increase confidence that the final product will perform as intended.

For many developers, the greatest value comes from understanding not only whether cells are alive, but whether they are healthy, functional, and capable of delivering the desired therapeutic outcome. By providing that deeper biological insight throughout development and manufacturing, LFC helps organizations build more robust processes and more consistent cellular medicines.

How is Radiance® used for CAR-T potency and characterization?

Radiance® provides real-time, label-free measurements of CAR-T cell activation, cellular fitness, and functional potency, helping teams better understand the biological state of their cell products from leukapheresis through final product release.

One of the most valuable applications is the qualification of incoming donor material. Not all starting material performs equally during manufacturing, and traditional viability measurements often fail to capture meaningful differences in cellular health and functional readiness. Radiance helps identify variability in donor-derived cell populations early, enabling manufacturers to better assess starting material quality and predict downstream manufacturing performance before significant time and resources have been invested.

Throughout manufacturing, Radiance can be used as a cellular Process Analytical Technology (PAT) to monitor activation, expansion, transduction, and other critical process steps. By measuring cellular responses directly, teams gain earlier visibility into process consistency, product quality, and emerging deviations that may impact yield, potency, or final product performance.

The platform also supports development of more biologically relevant potency assays by measuring functional cellular responses rather than relying solely on surface markers or endpoint assays. This deeper understanding of cellular fitness and function can help organizations improve manufacturing consistency, reduce process risk, strengthen comparability strategies, and ultimately increase confidence that the final CAR-T product will perform as intended.

For autologous therapies in particular, where every batch begins with a unique patient or donor, these insights can be invaluable for identifying sources of variability, predicting manufacturing success, and supporting the delivery of more consistent cellular medicines.

Can LumaCyte analyze stem cell populations?

Absolutely. Radiance® enables near real-time, label-free characterization of stem cell populations and can monitor changes associated with differentiation, maturation, expansion, reprogramming, and other critical cellular state transitions throughout the manufacturing process.

Stem cell products are particularly sensitive to changes in cellular health, phenotype, and functional state. Small shifts early in a process can ultimately affect expansion performance, differentiation outcomes, product consistency, and manufacturing success. Radiance helps teams detect and understand these changes as they occur, rather than waiting until the end of a process to discover deviations.

As a cellular Process Analytical Technology (PAT), Radiance provides continuous insight into the biological condition of the cells themselves, allowing researchers and manufacturers to track population quality, compare process conditions, identify emerging variability, and make data-driven adjustments before issues propagate downstream. This can improve process understanding, support scale-up and technology transfer activities, reduce manufacturing risk, and increase confidence that cells are progressing toward the desired therapeutic state.

By delivering rapid, functionally relevant measurements without labels or long and laborious off line assays, Radiance helps organizations move beyond periodic sampling and toward a more proactive and predictive approach to stem cell process control, enabling more consistent outcomes and more robust manufacturing processes, yields and outcomes.

What is AAV (Viral Vector) transfection monitoring and why does it matter?

AAV transfection is the process by which producer cells take up the genetic material required to create viral vectors. Because transfection efficiency directly influences vector yield, quality, and overall manufacturing performance, understanding how cells respond during this step is critical.

Radiance® measures cellular responses associated with transfection in minutes and without the need for labels, providing an early indication of process performance long before traditional methods can deliver results. These rapid insights help teams evaluate transfection success, optimize process conditions, better predict downstream harvest performance, and make informed decisions earlier in the manufacturing workflow. By identifying potential issues before they affect production, organizations can reduce process variability, improve consistency, and maximize vector yields.

How does Radiance® measure AAV (Viral Vector) transduction efficiency?

AAV transduction refers to the successful delivery of genetic material into target cells. Radiance precisely measures the cellular response to transduction (without the need of a helper virus) at the single-cell level, providing a functional view of the native transduction and how the cells are responding rather than relying solely on indirect markers.

This deeper understanding can help developers characterize product performance, improve potency assessments, and better understand the relationship between vector quality and biological activity. The result is a more complete picture of therapeutic performance and consistency.

Does LumaCyte support biologics and protein therapeutic programs?

Yes. LumaCyte supports biologics developers and manufacturers across the full product lifecycle, from cell line development and cell bank characterization through process development, scale-up, technology transfer, comparability, and commercial manufacturing.

Radiance® helps teams evaluate cell bank quality, compare clones, optimize media and culture conditions, assess cellular responses to bioreactor process changes, and monitor cellular fitness throughout production. Because the platform measures how cells are performing rather than simply whether they are alive or dead, it provides deeper insight into the biological health and consistency of the manufacturing process.

For organizations facing challenges with yield, process variability, or product consistency, LumaCyte’s scientists can also provide laboratory analytics, predictive modeling, and custom assay development services. Together, these capabilities help biomanufacturers make better-informed decisions earlier, reduce development risk, and build more robust manufacturing processes.

LumaCyte’s Radiance® Instrument & Supporting Software

What is Radiance®?

Radiance® is LumaCyte’s flagship instrument, powered by Laser Force Cytology™ technology. It delivers real-time, label-free single-cell analytics that help developers and manufacturers better understand cellular health, vitality, functional fitness, potency, and response to process conditions.

Rather than simply determining whether cells are alive or dead, Radiance provides deeper biological insight that can help organizations be better set up for success, improving process understanding, reducing variability, and making more informed decisions throughout both process development and manufacturing unit operations.

What is Illuminate™ software?

Illuminate™ is LumaCyte’s integrated software suite that powers the Radiance platform. It includes dedicated applications for instrument control, data analysis, and visualization creating a seamless workflow from sample acquisition through final results.

Designed for regulated environments, Illuminate helps teams manage complex cellular datasets efficiently while maintaining data integrity, traceability, and compliance requirements.

What is ReportR™?

ReportR™ is LumaCyte’s cloud-based automated analysis and report generation platform that automates data handling, analysis workflows, and provides customized or standard report generation.

By reducing manual processing and streamlining data review, ReportR helps teams spend less time managing data and more time acting on insights. This can accelerate decision making, improve consistency across studies, and simplify collaboration among scientific teams.

Is Radiance® compliant with data integrity regulations such as 21 CFR Part 11?

Yes. Both the Illuminate™ and ReportR™ software suites are designed to support regulated environments and are compliant with 21 CFR Part 11 requirements for electronic records, audit trails and electronic signatures.

This enables organizations to confidently incorporate Radiance data into development, manufacturing, and quality workflows while maintaining the traceability, security, and audit readiness expected in regulated industries.

Does LumaCyte offer services beyond the instrument itself?

Yes. Many customers partner with LumaCyte through our Laboratory & Biostatistical Modeling Services, which provide direct access to our scientists, application specialists, analytics experts, and predictive modeling capabilities.

Whether you need assistance developing a potency assay, evaluating comparability, characterizing a new process, or exploring a complex biological question, our team can help generate actionable insights without requiring an instrument purchase.

What training is available for new Radiance® operators?

Every new Radiance customer receives hands-on training from our PhD-level scientists as part of the installation process. In addition, the LFC Academy provides both introductory and advanced training programs designed to help users build confidence with the technology and accelerate adoption.

Our goal is to ensure customers are successful from day one, which is why training is paired with dedicated scientific support, method development assistance, and data analysis guidance during the onboarding period.

How do I get support for an installed Radiance® instrument?

Our support team is available to assist with technical questions, troubleshooting, software support, service requests, and application guidance.

We understand how important reliable data and instrument uptime are to your success. When you contact LumaCyte, you will work with a knowledgeable team that understands both the technology and the scientific challenges your organization is working to solve.

Can I see Radiance® applied to my specific therapeutic area?

Absolutely. One of the strengths of Radiance is its broad applicability across cell therapy, gene therapy, biologics, viral vectors, vaccines, regenerative medicine, and emerging modalities.

Our application specialists are always happy to discuss your specific workflow, challenges, and objectives and explore where label-free cellular analytics may provide value. Many customers are surprised to discover opportunities beyond their original use case once they begin evaluating the underlying biology of their process.