Real-Time Process Analytical Technology (PAT) for Continuous Production Monitoring
Advanced bioanalytics, as part of modern process analytical technology systems, 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 tools enable real-time bioprocess monitoring of variables like cell culture conditions, protein expression, and purification processes, ensuring both efficiency and product consistency.
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.
Real-Time Single-Cell Analysis for Biotherapeutics Production
LumaCyte’s Laser Force Cytology™ and Radiance® instrument deliver advanced, real-time single-cell analysis to optimize process development. By ensuring high-quality and consistent production of biotherapeutics, these cutting-edge tools empower manufacturers to streamline workflows and improve outcomes.
Cell Bank Characterization
Radiance® delivers precise analytics for evaluating the quality, viability, and consistency of cells used in cell banking. From small-scale cell bank characterization to large-scale resources for therapeutic production, Radiance® ensures that all cells meet stringent industry quality standards. The platform also supports advanced applications such as stem cell differentiation, allowing researchers to monitor and assess the transformation of pluripotent stem cells into specialized cell types. This is critical for ensuring reproducibility across multiple production batches and therapeutic applications.
Radiance® as a Real-Time Process Analytical Technology
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.
