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홈 > 제품정보 > 시약 > 해외 공식 대리점 > [20802-0500] CellGenix® GMP Stem Cell Growth Medium
[20802-0500] CellGenix® GMP Stem Cell Growth Medium
제품코드 : 20802-0500
제품정보 : CellGenix® GMP SCGM is an optimized, xeno-free medium used for the serum-free expansion of low numbers of isolated human hematopoietic stem and progenitor cells (HSCs/CD34+ cells). In addition, our SCGM is proved to be highly efficient for the expansion a
- Serum-free and xeno-free medium
- Reliable and consistent cultivation of HSCs and NK cells
- FDA Drug Master File available (on request)
- Compliant to USP Chapter <1043>
제품문의
-
- 전화번호
- 2292-8870
- 이메일
- dreamcell@dreamcell.co.kr
제품상세
General Information
CellGenix® GMP SCGM is widely used for standardized generation of autologous and allogeneic cell therapies using HSCs, NK cells or CIK cells.
We offer the cytokines and growth-factors needed for optimal growth of one of these cell types separately. This gives you the freedom to customize and create your own optimal cytokine mixture. To fit different cell and gene therapy manufacturing processes, we conveniently offer our media in both bags and in bottles.
Technical Details
Osmolality
290-350 (mOsm/kg H2O), determined according to Ph. Eur.
pH
7.2 – 7.5, determined according to Ph. Eur.
Endotoxin
≤ 1 EU/ml, determined according to Ph. Eur.
Sterility
Sterility test of the final product determined according to Ph. Eur.
Mycoplasma
Mycoplasma PCR-test according to Ph. Eur.
Functionality assay
Expansion of human CD34+ cells
Intended use
For clinical ex vivo use. Not intended for human in vivo application.
Handling Instructions
Shipment
Ambient temperature. Please refer to Technote Shipment of CellGenix® GMP Media at Ambient Temperatures
Storage & Stability
Store at +2°C to +8°C. Light protection recommended.
Primary Packaging Details
Medium Bottle
- Material of bottle: Polyethylene Terephthalate (PET), classified USP Class VI
- Material of bottle top: High-Density Polyethylene (HDPE), classified USP Class VI
Medium Bag – Flexboy®
- Material of bag chamber: Ethylene-Vinyl Acetate (EVA) with a core layer of Ethyl Vinyl Alcohol (EVOH) as gas barrier, classified USP Class VI
- Material of bag tubing: Ethylene-Vinyl Acetate (EVA), Silicone, PVC (DEHP-free, suitable for sterile welding), classified USP Class VI
- Ports: 1x Male Luer Lock Port 1/8″, 1x Female Luer Lock Port 3/16″ with 1x Clave® Connector, 1x filling port (exclusively used for filling the media into the bag during the manufacturing process)