November 5, 2024
Sponsored by LumaCyte
Laser Force Cytology (LFC) is a cutting-edge, label free technology that measures the intrinsic biophysical and biochemical properties of single cells by applying optical and hydrodynamic forces. This technology doesn't require dyes, antibodies, or fluorescent labels, making it a non-invasive method to analyze cells in real-time, allowing the innate cellular response to be quantitatively measured. The technology has a broad a deep applicability across advanced cellular therapies, including cell viability, T cell activation, transfection, transduction and differentiation.
In the context of real-time cellular Process Analytical Technology (PAT) analytics, LFC offers significant value by providing continuous, precise measurements of cellular properties. This enables manufacturers to monitor critical parameters and make adjustments in real-time, leading to improved process knowledge and better production outcomes. Understanding the cellular dynamics across a process opens the door to adaptive manufacturing which is receiving increased focus from regulators. Biomanufacturing processes are complex, involving intricate steps from cell culture to purification and formulation. Ensuring product quality, consistency, and yield is paramount. However, traditional batch-based monitoring and current quality control measures may not provide the real-time insights needed to ensure consistent high-quality production and yields to meet growing demand. Real-time precision cellular analytics offer a game-changing approach to improved process knowledge and better production outcomes. By integrating cell measurements, and multivariate analysis / machine learning, manufacturers can monitor critical parameters continuously. These analytics enable early detection of deviations, allowing timely adjustments/optimizations to maintain product quality. By integrating real-time monitoring and potency testing into complex biomanufacturing processes, manufacturers can enable better quality control measures that improve product quality and maintain efficacy throughout the manufacturing journey.
Leveraging novel analytics can take your processes to the next level by improving both upstream and downstream process controls. Utilizing real-time data, manufacturers can monitor critical cell-based parameters during cell culture, allowing for timely adjustments to optimize growth conditions which can contribute to the success of downstream processes. This approach ensures the maintenance of high cell fitness and product concentrations, ultimately leading to improved production quality and consistency.
Reducing the significant challenges that often arise from complex comparability studies manufacturers can assess the impact of manufacturing changes on product quality, ensuring that modifications such as process changes, scale-up, or raw material substitutions do not have adverse effects on the final product. By conducting comparability studies efficiently using a rapid PAT, manufacturers can maintain product consistency and quality while implementing changes, thus addressing a key challenge in the development and manufacturing of biologic medicines. Additionally, carefully selecting analytics that can be beneficial across both early process development, manufacturing and QC can be game changers in ensuring analytical assay consistency across key production phases.
When it comes to predictive CAR T donor characterization, LFC plays a crucial role by enabling precise and reliable quantitation and qualification of donor PBMCs or T cells. By characterizing cells based on their intrinsic properties, LFC can predict the success of a manufacturing process and measure the functional potency of CAR T cells throughout the production process. This ensures that only the most viable and potent cells are used, with the opportunity to improve the overall efficacy of CAR T therapies.
In summary, Laser Force Cytology technology brings immense value as a real-time cellular PAT analytic by providing accurate, non-invasive measurements that enhance the development and improve the manufacturing success of ATMPs. The rapid transformation of biomanufacturing, particularly in CGTs and vaccines, underscores the critical need for advanced analytics that improve manufacturing success and ensure that the growing demand for these life-saving treatments and cures are met. Real-time precision analytics and Process Analytical Technology (PAT) offer game-changing solutions to the complex challenges inherent in biomanufacturing processes. By integrating novel analytics and leveraging regulatory guidance, manufacturers can rapidly optimize processes, ensure production quality and consistency, and significantly improve product yields all while ensuring patient safety and efficacy. As the biopharmaceutical industry continues to evolve, embracing these innovative approaches will be essential for driving progress and delivering impactful therapies to patients worldwide.
Please visit www.lumacyte.com for more information.
To schedule a meeting with a Laser Force Cytology™ expert, please email [email protected].
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