CAR-T Release Testing
CAR-T Release Testing
CAR-T (Chimeric Antigen Receptor T-cell) therapy represents a groundbreaking advancement in cancer treatment, as it harnesses the power of genetically modified T-cells to specifically target and eliminate cancer cells. This innovative approach offers remarkable efficacy in treating certain types of refractory or relapsed cancers, providing new hope for patients who have exhausted conventional treatment options.
At Avance Biosciences, we understand the critical nature of providing fast quality control of your CAR-T drug product. We have comprehensive Quality Control (QC) solutions tailored to ensure the highest standards of product safety, efficacy, and consistency to support in the following areas:
Key CAR-T Services
Critical Quality Attributes
Assay
Description
CAR transgene integration site analysis
Verify the CAR transgene sequence within the T-cells using PCR and Sanger sequencing or NGS.
Potency
Cell-based Potency Assays
Assess the ability of CAR-T cells to elicit an antitumor response, typically by measuring their cytotoxicity against target cells or evaluating other effector functions. Requires development of assay specific to target
Transduction Efficiency Analysis
Determine the % of transduced cells using flow cytometry or QPCR/ddPCR.
Potency
Cell-based Potency Assays
Assess the ability of CAR-T cells to elicit an antitumor response, typically by measuring their cytotoxicity against target cells or evaluating other effector functions. Requires development of assay specific to target.
Viability and Cell Counting
Determine the viability and concentration of CAR-T cells in the final product using NC-200 or flow cytometry.
Replication Competent Lentivirus (RCL) Testing
Perform a rapid QPCR-based assay to verify CAR-T drug product is free from RCL.
