June 3rd, 2025
LumaCyte, a leader in advanced cellular analytics, announces that its transformative Laser Force Cytology™ (LFC™) technology has been included in its first Certificate of Analysis (CoA) for viral infectivity measurement. This milestone underscores the growing role of precision analytics in reducing variability in starting materials, ensuring greater product consistency, safety, and reliability across complex bioprocess and manufacturing workflows. By delivering real-time, label-free insights, LFC™ enhances upstream characterization, helping manufacturers optimize processes and improve therapeutic outcomes with greater predictability and control.
Laser Force Cytology™ leverages optical and fluidic force measurements to deliver real-time, label-free cellular response data, providing developers and production scientists with deeper insights into functional biological assays. “The inclusion of Laser Force Cytology in the Certificate of Analysis (CoA) of a major industry reference material represents a pivotal step toward a new standard in viral infectivity assessment,” said Sean Hart, CEO and CSO of LumaCyte. “Precision analytics are essential for ensuring consistent, reliable raw materials for cell and gene therapies as well as vaccines. We’re proud to support an industry-wide shift toward reducing variability through the implementation of real-time precision measurements and enhanced safety.”
The FDA has increasingly emphasized the need to better characterize and reduce variability in starting materials for advanced cellular and gene therapies, when possible, recognizing that inconsistencies in raw materials can significantly impact final product quality, efficacy, and safety. Precision analytics play a vital role in addressing this challenge by enabling real-time, objective characterization of critical bioprocess inputs. Technologies like Laser Force Cytology™ provide comprehensive insights into cellular and viral material attributes, allowing manufacturers to meet stringent regulatory expectations while improving reproducibility and reliability. By integrating precision measurements from the outset, organizations can enhance process control, drive efficiency, and support the development of high-quality therapeutics that align with evolving regulatory guidelines.
This milestone marks a pivotal shift in the biopharmaceutical industry as it moves beyond outdated assays and traditional processes, toward advanced precision analytics to deepen bioprocess understanding and reduce risk. Without a strong analytical foundation during early development, downstream approvals and commercial-scale production become increasingly difficult. By harnessing real-time process and product insights, precision analytics establish the essential foundation for reliable therapeutic development and manufacturing. These advanced tools drive consistency, optimize efficiency, and minimize risk — ensuring treatments are developed with greater accuracy, reproducibility, and clinical success from the outset .
