Laser Force Cytology™ as a Solution to Cell Banking Analytical Challenges
Cell bank characterization serves as the foundation for ensuring the reproducibility, safety, and quality of biopharmaceutical products. A well-characterized cell bank, whether it be a master or working cell bank, provides a standardized and well-documented source of cells that is essential for the production of therapeutic proteins or vaccines. The comprehensive analysis of cell banks involves evaluating crucial parameters such as cell identity, viability, and stability, enabling manufacturers to establish robust processes, adhere to regulatory guidelines, and ultimately deliver biotherapeutics with consistent efficacy and safety profiles. Accurate cell bank characterization not only guarantees the reliability of the production process but also underlines the commitment to producing high-quality biopharmaceuticals for patients worldwide.
Cell banking in biomanufacturing faces analytical challenges related to ensuring the stability, identity, and viability of stored cells. Heterogeneity within cell populations, coupled with the need for real-time monitoring, poses hurdles in maintaining the quality of cell banks. In some cases, problems or inconsistencies with individual vials thawed from a specific cell bank or donor lot are not discovered until well after thawing, resulting in lost time and resources. This demonstrates the need for analytics to rapidly asses cells to ensure high quality and consistent starting material.
Laser Force Cytology™ (LFC) emerges as a powerful solution, offering real-time, label-free single-cell analysis. LFC’s capacity to provide detailed insights into a population of cells helps address the challenge of variability, enabling precise monitoring of viability and stability without the use of exogenous markers. Using LFC data, a multivariate description of a cell population can be created to ensure consistency by detecting potential changes in viability or contamination, as well as help optimize the cryopreservation process by quickly identifying the effect of process changes on cells. By overcoming these challenges, LFC enhances the analytical robustness of cell banking processes, fostering the production of consistent and high-quality biopharmaceuticals.
Predictive Insights for Cell Health Monitoring
Radiance® can rapidly monitor cell health conditions and characterize changes in cell populations to ensure consistent process performance. This study compared Vero cells frozen with different methods to a standard reference protocol. Cells were then analyzed on Radiance® immediately post thaw. A significant reduction is seen in the Radiance® Optical Force Index for samples without DMSO (Sample 3) and rapid (uncontrolled) freezing (Sample 4), indicating that those process changes adversely affected the cell populations post thaw. Other studies have been able to predict cell-based potency loss during the freezing process using LFC data collected on the cells prior to cryopreservation. This demonstrates how Radiance® can be used as a tool to help predict product or process performance based on the cell starting material.
Standard/Same as Reference
High FBS Concentration