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GMP Serum-free Dendritic Cell Medium (DC)無血清培養(yǎng)基產(chǎn)品信息：

Data Sheet: CellGro®/ CellGenix™

GMP Serum-free Dendritic Cell Medium (DC)

Order No.: 20801-0500 and 20801-0100 (bottle), 20901-0500 (bag)

Main components

Salts, Sugars, Amino Acids, Vitamins, Buffers

Contains phenol-red (pH-indicator)

Contains L-glutamine

Human proteins

Transferrin (human plasma-derived)

Albumin (human-plasma-derived, licensed medicinal product for human use, Ph. Eur.)

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

Applications Generation of dendritic cells

Expansion of T-cells

Release specifications:

Osmolality 260 – 320 (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 Generation of human dendritic cells from CD14+monocytes

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 intendedfor human in vivo application.Quality and raw material statemet 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.Apart from one exception, the formulation does not contain animal derived components. (A synthetic lipid contains chicken egg-derived lecithin. This lipid is a

licensed medicinal product for human use.) Human proteins have been collected from healthy donors at the time of collection, and samples of their donations were tested individully and found negative for viral diseases by approved methods (HIV1/HIV2, HBV,HCV, Parvovirus B19).

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