Zenogen Pharma HSC-BANKER GMP grade

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조혈줄기세포 동결보존용 GMP 등급 시약으로, 혈청 및 동물 유래 성분이 없는 Ready-to-use 제품입니다. DMSO/DEXTRAN 기반 기존 프로토콜과 동등 이상의 보존 효율을 제공합니다. JP, EU, US, PIC/S GMP 기준에 따라 제조되며 2–8℃에서 3년 안정성을 유지합니다.

카탈로그번호: 13929
브랜드: Zenogen Pharma
카테고리: Cell Banking
판매단위: pk

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Zenogen Pharma · Zenogen Pharma HSC-BANKER GMP grade

Zenogen Pharma HSC-BANKER® GMP grade

For inquiries including COA (certificate of analysis), please send a message to:
zenogen_pharma-post@zenoaq.jp

Description

15 mL
For Cryopreservation of Hematopoietic Stem Cells
HSC-BANKER® GMP grade
ZENOAQ RESOURCE CO., LTD.
1-1 Shinmori Sakaegawa, Asaka-machi, Koriyama, Fukushima 963-0196 Japan

HSC-BANKER® GMP grade is an optimized cryopreservation medium for hematopoietic stem cells.
It is a ready-to-use product and has been reported that the cryopreservation outcomes of HSC-BANKER® are at least equivalent to those of the conventional protocol using DMSO and DEXTRAN.

It is completely free of serum and animal-derived components, and contains only USP, EP, JP graded ingredients or JP excipients.
Manufactured in a facility compliant with JP, EU, US, and PIC/S GMP guidelines, and quality is controlled under JP GMP standards.

※ This product has been registered in MF within PMDA in 2019.

Comparative Study

This data is provided by Japan Red Cross Society.

항목	8%DMSO+0.8% DEXTRAN (N=11)	HSC-BANKER 5%DMSO (N=11)
Total Nucleated Cell recovery rate	101.0±5.4	101.9±6.9
CD34 positive cell recovery rate	80.0±8.8	95.0±14.8
		P=0.008
Total-colony forming unit recovery rate	85.8±12.4	95.7±16.8
colony forming unit-granulocyte macrophage recovery rate	92.7±17.9	92.3±21.5
Viable cells recovery rate (by fluorescence microscope) AO/EB	88.6±7.9	86.8±2.9
Viable cells recovery rate (Flow Cytometry) CD45	71.4±9.8	74.0±6.1
Viable cells recovery rate (Flow Cytometry) CD34	99.1±0.8	99.4±0.7

Source: The Japan Society for Hematopoietic Cell Transplantation (2015)

Storage and Stability

항목	내용
저장 온도	2–8℃
안정성	제조일로부터 3년 (미개봉 상태, 지정 온도 보관 시)

Freezing Protocol

Remove red blood cells from the cord blood collection.
Separate the cord blood into plasma and buffy coat fractions by centrifugation at 400 × g for 10 minutes.
Reduce the volume of the cord blood to 13 mL by removing the plasma.
Add gently an equal volume (13 mL) of HSC-BANKER® GMP grade to the cord blood, and place the freezing bag in a controlled-rate freezer to gradually freeze the cord blood to -80℃.
After reaching below -80℃, transfer to a liquid nitrogen tank for long-term storage.

SDS

SDS: HSC-BANKER® GMP grade

Disclaimer

HSC-BANKER® GMP grade is not itself a pharmaceutical.
ZENOAQ and Zenogen Pharma make no warranty, express or implied, as to the fitness or suitability of this product for any particular purpose and/or merchantability unless the use is intended for research.