GMP Serum-free SCGM
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產(chǎn)品英文名稱:CellGenix GMP Serum-free SCGM Xeno-free
產(chǎn)品中文名稱: GMP級(jí)干細(xì)胞無血清培養(yǎng)基
CellGro GMP級(jí)干細(xì)胞無血清培養(yǎng)基 CellGenix GMP Serum-free SCGM Xeno-free 擴(kuò)增NK細(xì)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級(jí)干細(xì)胞無血清培養(yǎng)基 CellGenix GMP Serum-free SCGM Xeno-free簡(jiǎn)介:
本產(chǎn)品制造,測(cè)試和發(fā)布符合有關(guān)GMP-準(zhǔn)則。 USP章<1043>“細(xì)胞,基因,和輔助材料組織工程產(chǎn)品“一直被認(rèn)為是該產(chǎn)品的設(shè)計(jì)。除了一個(gè)例外,該制劑不含有動(dòng)物來源的組分。 (合成脂含有雞蛋源性卵磷脂。此脂質(zhì)是許可的醫(yī)藥產(chǎn)品供人類使用。)在收集時(shí)人類蛋白質(zhì)已收集來自健康捐贈(zèng)者,和他們的捐款的樣本單獨(dú)進(jìn)行測(cè)試,發(fā)現(xiàn)為陰性病毒性疾病通過經(jīng)批準(zhǔn)的方法(HIV1/HIV2,乙型肝炎,丙型肝炎,細(xì)小病毒B19)。
CellGro GMP級(jí)干細(xì)胞無血清培養(yǎng)基應(yīng)用:
?造血干細(xì)胞和祖細(xì)胞的培養(yǎng)
?NK細(xì)胞的擴(kuò)展
德國CellGenix公司 CellGro GMP級(jí)干細(xì)胞無血清培養(yǎng)基 CellGenix GMP Serum-free SCGM Xeno-free產(chǎn)品特點(diǎn):
?更方便的純化及下游加工處理
?對(duì)細(xì)胞功能的精確評(píng)估
?不斷增加的定義
?更一致的表現(xiàn)
?不斷增加的生長及生產(chǎn)力
?更好地控制生理反應(yīng)
?高靈敏度檢測(cè)細(xì)胞內(nèi)的中介體
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