产品英文名称：CellGenix GMP Serum-free SCGM Xeno-free

产品中文名称： GMP级干细胞无血清培养基

CellGro GMP级干细胞无血清培养基 CellGenix GMP Serum-free SCGM Xeno-free 扩增NK细胞 20802-0500 英文描述：

Main components

Salts, Sugars, Amino Acids, Vitamins, Buffers

Contains phenol-red (pH-indicator)

Contains L-glutamine, -Mercaptoethanol

Human proteins

Albumin (human-plasma-derived, licensed medicinal product for human use,

Ph. Eur.)

Insulin (human recombinant, yeast-derived, Ph.Eur., USP)

Applications

• Cultivation of hematopoietic stem and progenitor cells

• Expansion of NK-cells

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.

Functionality assay Expansion of human CD34+ cells

Mycoplasma Mycoplasma PCR-test of Vero cells, according to Ph.Eur.

Appearance Clear, red liquid

Transport Ambient temperature

Storage at +2°C to +8°C. Light protection recommended

Shelf life

2 years from date of production

Minimum 6 months from date of shipping

Intended use For clinical ex vivo use. Not intended for human in vivo application.

Quality and raw material statement

This product is manufactured, tested and released in compliance with the relevant GMP-guidelines. USP chapter <1043> “ancillary materials for cell, gene, and tissue-engineered products” has been considered in the design of this product.The formulation does not contain animal derived components (xeno-free).Human proteins have been collected from healthy donors at the time of collection,and samples of their donations were tested individually and found negative for viral diseases by approved methods (HIV1/HIV2, HBV, HCV, Parvovirus B19).

CellGro GMP级干细胞无血清培养基 CellGenix GMP Serum-free SCGM Xeno-free简介：

本产品制造，测试和发布符合有关GMP-准则。 USP章<1043>“细胞，基因，和辅助材料组织工程产品“一直被认为是该产品的设计。除了一个例外，该制剂不含有动物来源的组分。 （合成脂含有鸡蛋源性卵磷脂。此脂质是许可的医药产品供人类使用。）在收集时人类蛋白质已收集来自健康捐赠者，和他们的捐款的样本单独进行测试，发现为阴性病毒性疾病通过经批准的方法（HIV1/HIV2，乙型肝炎，丙型肝炎，细小病毒B19）。

CellGro GMP级干细胞无血清培养基应用：

•造血干细胞和祖细胞的培养

•NK细胞的扩展

德国CellGenix公司 CellGro GMP级干细胞无血清培养基 CellGenix GMP Serum-free SCGM Xeno-free产品特点：

•更方便的纯化及下游加工处理

•对细胞功能的精确评估

•不断增加的定义

•更一致的表现

•不断增加的生长及生产力

•更好地控制生理反应

•高灵敏度检测细胞内的中介体