Hycells New Product | Our In-House Anti-FMC63 Antibody Is Now Available!
Release Date:
2024-04-25 14:06
Product Background Overview
In the research, development, and manufacturing of CAR-T products, the CAR expression rate is a critical research parameter and performance indicator that is integral throughout preclinical studies, process development, and product quality control, and it also serves as an excellent companion diagnostic marker in subsequent clinical trials.
Currently marketed products employ advanced genetic engineering to equip patients’ own T cells with a chimeric antigen receptor (CAR)—a targeting system that specifically recognizes lymphoma—enabling precise elimination of tumor cells. CD19 is an antigen protein expressed on the surface of various hematologic malignancy cells, including B-cell lymphoma and leukemia cells, making it an ideal target for CAR-mediated recognition. Among these products, the single-chain variable fragment (scFv) within the CAR construct serves as the core component of the targeting system and plays a critical role in determining whether CAR-T cells can achieve precise cytotoxicity against tumor cells.
FMC63, a murine monoclonal antibody that targets human CD19, has had its scFv sequence widely incorporated into several commercially available CAR-T products. The anti-idiotypic antibody Anti-FMC63 Antibody, owing to its specific binding to the FMC63 scFv, exhibits low background, high specificity, and exceptional sensitivity, making it a common choice for detecting CAR expression derived from the FMC63 scFv. Shanghai Hycells Biotechnology Co., Ltd.’s in-house developed Anti-FMC63 Antibody, with its superior specificity and sensitivity, is specifically designed for flow cytometric monitoring of CAR expression. It can be flexibly paired with various fluorescent dyes to suit different flow cytometry assays, offering cost-effectiveness and enhanced efficiency.
Anti-FMC63 antibody
Preclinical & Clinical Validation Data
1. Preclinical validation data
Experimental Procedure
Experimental Procedures
1) On Day 0, cells are seeded and Hycells’ proprietary PBMC samples are expanded using the IL-15 feeder method;
2) On Day 3, perform CAR-19 viral transduction (MOI = 15, with a viral infection enhancer);
3) On Day 12, assess NK cell purity and determine the transduction positivity rate using our proprietary G4S antibody, our proprietary FMC63 antibody, and a competitor’s FMC63 antibody.
DAY 12 Purity Status
The transduced and expanded CD19 CAR-NK cells were analyzed using Hycells’ proprietary G4S-FITC/PE/APC reagents (catalog numbers: GS-ARFT25, GS-ARPE25, and GS-ARAP25), which yielded a relatively consistent positive staining rate.
| Summary of CAR Positive Rates for Hycells G4S Antibodies (%) | ||
| FITC | PE | APC |
| 63.08 | 60.51 | 60.84 |
NK cells expanded following transduction were simultaneously tested with Hycells (catalog no.: FMC-ARFT25) and a domestically produced competitive product, FM-C63 FITC-labeled antibody.
| Summary of FM-C63 Antibody CAR Positivity Rate (%) | |
| Product | FITC |
| Hycells | 56.67 |
| Domestic competitors | 57.68 |
Conclusion: Both Hycells and the domestically produced competitive product FM-C63, when labeled with FITC-conjugated antibodies, exhibit distinct population distributions with consistent positive rates.
2. Clinical validation data— FMC63 antibody detection of CAR-positive rate in whole blood
Experimental Procedure
Experimental Procedures
1) Collect whole blood from two donors and perform a count.
2) Revive cryopreserved CAR-NK-CD19 cells and perform cell counting.
3) Mix the two cell types at a 1:1 ratio.
4) Perform red blood cell lysis using red blood cell lysis buffer, and seed the cells at a density of 1 × 10^5 cells per well.
5) Add the appropriate flow cytometry antibodies and incubate at 4°C for 20–30 minutes.
6) Flow cytometry
Figure 1 shows a flow cytometry comparison between Hycells’ FMC63 FITC-labeled antibody and a comparable competitive product, using clinical samples f
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