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

Identity

CAR+ expression

Confirm CAR expression on T-cell surface using flow cytometry

CAR transgene integration site analysis

Verify the CAR transgene sequence within the T-cells using PCR and Sanger sequencing or NGS

Purity

Immunophenotyping

Determine % of immune cell subsets in the DP by flow cytometry

CAR+ T cell percentage

Determine the % of CAR+ T cells by flow cytometry

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

Vector Copy Number (VCN) Analysis

Confirm the presence and copy number of the CAR transgene in the CAR-T cell drug product using QPCR or ddPCR

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

Safety

Sterility Testing

USP <71>

Replication Competent Lentivirus (RCL) Testing

Perform a rapid QPCR-based assay to verify CAR-T drug product is free from RCL

Safety

Sterility Testing

USP <71>

Endotoxin Testing

USP <85>

Mycoplasma Testing

QPCR-based rapid mycoplasma test covering 17 Mycoplasma species.

Other

pH

USP <791>

Osmolality

USP <785>

Have Questions?

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