Zenogen Pharma STEM-CELLBANKER® EX GMP grade

STEM-CELLBANKER® EX GMP grade

Supplier: Zenogen Pharma

For inquiries including COA (Certificate of Analysis), please contact:
zenogen_pharma-post@zenoaq.jp

Description

STEM-CELLBANKER® EX GMP grade (SCB EX) is a cell cryopreservation solution designed for advanced cell therapy applications.
It contains DMSO and is a Xeno-Free, serum-free, and animal component-free formulation composed only of USP, EP, JP graded ingredients.
SCB EX can preserve human hematopoietic stem cells and human adipose-derived stromal/stem cells (ADSCs) while maintaining high viability and functionality.

Manufactured in facilities compliant with JP, EU, US, and PIC/S GMP guidelines, ensuring consistent quality and reproducibility.

Note:

• Registered in MF (PMDA, Japan) in 2020 and BBMF (CBER/FDA, USA) in 2022.
• Composition identical to HSC-BANKER® GMP grade.

Label Information (from product image)

100 mL
Xeno-Free Cell Cryopreservation Solution
STEM-CELLBANKER® EX GMP grade

NIPPON ZENYAKU KOGYO CO., LTD.
1-1 Tairanoue Sasagawa, Asaka-machi, Koriyama, Fukushima 963-0196 Japan

ZB-02
22.02

Application

Cryopreservation performance test using Adipose-Derived Stromal/Stem Cells (ADSC)
Test conducted by EMO Biomedicine.

1. Cell Viability Test

ADSCs were cryopreserved with SCB EX for 4, 12, 24, and 48 weeks.
Viability was evaluated immediately after thawing and after overnight resting.
Cells preserved with SCB EX maintained high viability even after long-term storage.

Extracted Data from Image:

2. Cell Recovery Test

ADSCs were cryopreserved for 4, 12, 24, and 48 weeks.
Cell attachment and growth rate were measured after thawing and cultivation.

Extracted Data from Image:

Growth rate (Doubling Time) was stable across all time points (0–60 hours range).

3. Cell Identity Test

Cell identity was evaluated using flow cytometry for positive and negative markers.
Results showed no change in marker expression after long-term cryopreservation.

• Positive markers: CD29, CD73, CD90, CD105
• Negative markers: CD11b, CD19, CD34, CD45, HLA-DR

4. Cellular Function Test

(IDO Quantification and Suppression of T Cell Proliferation Assay)
ADSCs showed unchanged IDO expression and maintained ability to suppress T cell proliferation even after long-term cryopreservation.

Protocol (CELLBANKER® series)

Freezing

1. Ensure cells are in log phase and contamination-free.
2. Perform cell count to determine viability.
3. Pellet cells (3–5 min, 1,000–2,000 rpm, 4℃) and remove supernatant.
4. Suspend cells in CELLBANKER medium (1 ml per 5×10⁵–5×10⁶ cells).
5. Dispense 1 ml aliquots into labeled cryovials.
6. Freeze at -80℃ for ≥24 h, then transfer to liquid nitrogen if needed.

Note: Optimum protocol may vary by cell type.

Thawing

1. Quickly thaw frozen cells at 37℃ in a shaking water bath.
2. Dilute each 1 ml of cells with 10 ml of complete medium.
3. Pellet cells (3–5 min, 1,000–2,000 rpm, 4℃) and remove supernatant.
4. Resuspend in complete medium and plate in culture flask.
5. Continue standard culture procedures.

If survival rate is low, try slow freezing using a freezing box.

Storage and Stability

SDS

STEM-CELLBANKER® EX GMP grade SDS (PDF)

Disclaimer

STEM-CELLBANKER® EX GMP grade is not a pharmaceutical product.
ZENOAQ and ZENOAQ RESOURCE make no warranty, express or implied, regarding fitness for any particular purpose unless used for research.

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