Gene modification cell therapy involves removing cells from a patient and genetically modifying them to introduce a new gene or correct a faulty existing gene. Chimeric antigen receptor (CAR)-T cell therapy is a key example, outlined in the figure below. First, T cells are removed from the patient (1) and can undergo qualification/testing using Radiance and LFC which may predict outcome and guide the biomanufacturing process (1). The cells are then genetically modified through delivery of a new gene using a viral vector (2). This gene modification reprograms the T cells to recognize and attack a certain target cancer cell, thereby promoting specific cancer cell destruction and clearance. The next step in the process is to expand (3) or activate and expand/grow the modified T-cells into a large enough quantity, followed by potency testing and formulation (4) prior to infusing the modified cells into the patient (5) to treat their disease, in this case cancer. Radiance and LFC may allow for the effective monitoring and tracking of key biomarkers within the process that correlate to the success or failure of the therapy within the patient.
Laser Force Cytology™ (LFC) and Radiance® label-free approach to cell therapy research and biomanufacturing has significant value in expediting the process, decreasing costs, and ensuring therapy effectiveness and quality.
Radiance® enhances the highly complex biomanufacturing process for cell therapies by providing new insights to cell therapy research and process development.
Current process development assays are fraught with difficult and time-consuming steps requiring highly skilled scientists and bioengineers to produce these life saving treatments and cures.