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Biomanufacturing & PAT Analytics

Real-Time Process Analytical Technology (PAT) for Continuous Production Monitoring

Advanced bioanalytics play a pivotal role in the success of biomanufacturing by providing crucial insights into process development and ensuring stringent quality control. In biopharmaceutical production, these sophisticated analytical tools enable researchers to monitor and optimize key parameters, such as cell culture conditions, protein expression, and purification processes. The precision afforded by advanced bioanalytics not only enhances the efficiency of biomanufacturing processes but also ensures the consistency and quality of the final product. From accelerating process development to guaranteeing adherence to regulatory standards, these tools are indispensable in the pursuit of robust and reliable biomanufacturing practices, ultimately contributing to the production of safe and effective biotherapeutics.

The Challenge

Current analytical challenges for biomanufacturing include the characterization of complex processes and products, including viruses and mammalian cells. In contrast to small molecules, which can be characterized using well-defined techniques, these advanced therapies often require time-consuming and resource-intensive analysis. Another hurdle is integrating real-time, high-throughput analytics into biomanufacturing workflows, necessitating innovative solutions to ensure efficient and reliable monitoring of critical parameters.

Our Solution

LumaCyte’s Radiance®, a label-free single-cell analysis platform, delivers advanced analytics for real-time bioprocess monitoring and quality control strategies, quantitating production process data in minutes rather than days. This allows effective and efficient decisions to be made for rapid optimization in production by eliminating the need for post-production quantification assays that can take days or even weeks beyond the end of the run. By reducing the time to result, processes can be rapidly optimized and monitored to ensure product consistency.

Real-Time Process Monitoring

With Radiance®, sample data is acquired and production processes quantitated within minutes, eliminating the delays associated with post-production quantification assays that traditionally take days or even weeks beyond the run’s conclusion.

Accelerated Time to Result

The platform enables effective and efficient decisions for rapid process optimization, reducing the time to result and allowing for on-the-fly adjustments to ensure product consistency without the wait time associated with traditional assays.

Streamlined Quality Control Strategies

The instrument’s ability to eliminate the need for prolonged post-production quantification assays streamlines the quality control process, ensuring that processes are rapidly optimized and monitored, ultimately contributing to enhanced product consistency.

LumaCyte’s Laser Force Cytology™ and Radiance® instrument provide real-time, single-cell analysis, optimizing process development and ensuring high-quality and consistent production of biotherapeutics.

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Cell Bank Characterization

Offering precise single-cell analysis for evaluating the quality, viability, and consistency of cells stored in cell banks

Process Optimization & Scale Up

An analytic that enhances the efficiency, reproducibility, and quality control of biomanufacturing process development

In Process Monitoring

Facilitating precise tracking and optimization of critical parameters throughout biomanufacturing processes

Radiance® as a Real-Time Process Analytical Technology

Laser Force Cytology™

Real-Time Optimization

Radiance® facilitates real-time process optimization, ensuring dynamic adjustments for enhanced efficiency.

Enhanced Process Understanding

Increase your process knowledge and grasp a deeper understanding of process variability with the advanced capabilities of Radiance®.

Contamination Monitoring and Mitigation

Enable real-time contamination monitoring, allowing for swift mitigation actions to prevent potential batch failures before they occur.

Improved Product Quality and Yield

Experience a substantial boost in product quality and yield through the real-time analysis of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) with Radiance®, ensuring consistently superior outcomes.

Detection of Spiked Adventitious Virus in a Live Viral Vaccine Using Laser Force Cytology™

Here, samples were collected from Vero cells growing on microcarriers in a bioreactor. Changes in the optical force index distribution and other LFC™ data demonstrate the capability of Radiance® to differentiate between different viral conditions as a means of rapidly detecting changes in process condition.

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