1003-050 GMP Recombinant Human Interleukin-4 （rh IL-4）, USP grade

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GMP Recombinant Human Interleukin-4 (rh IL-4), USP grade USP級(jí)人重組白介素4產(chǎn)品信息：

Data Sheet: CellGro®/ CellGenix™

GMP Recombinant Human

Interleukin-4 (rh IL-4), USP grade

Order No.: 1003-050

Source

A DNA sequence encoding the mature IL-4 protein (Yakota, T. et al., 1986,

PNAS 83:5894) was expressed in E. coli

Molecular mass

The methionyl form of the E. coli expressed mature human IL-4 contains 130 amino acid residues and has a molecular mass of 14 kDa

Identity

Confirmed by DNA-sequencing of the expression plasmid in end of production (EOP)-cells, Western Blot, and N-terminal sequencing of the final product

Purity

≥97%, as determined by SDS-PAGE (under reducing and non-reducing

conditions) and visualized by Silver staining

Endotoxin level

< 50 EU/mg, as determined by LAL gel clot test according to Ph.Eur.

Residual host-cell DNA

≤1 ng/mg, as determined with the Threshold®system

Activity

0.5x107 – 2x107

USP units per mg1

Measured in a cell proliferation assay using a human factor-dependent cell line, TF-1 (Kitamura, T. et al., 1989, J. Cell Physiol. 140:323-334) USP units are equivalent to international units (IU)

Sterility

Sterility test according to Ph.Eur. of the vialed product (direct inoculation)

Formulation

Lyophilized from a 250 μg/ml, 0.2μm sterile-filtered solution in PBS without any carrier materials and preservatives

Amount per vial

50 ± 7.5 μg, as determined by spectrophotometrical measurement at 280 nm

using PBS as reference (A280= 0.63 for a concentration of 1 mg/ml IL-4 in PBS)

Transport

Ambient temperature

Storage at

-20°C or below. Avoid repeated freeze-thaw cycles

Shelf life

Minimum 6 months from date of shipping

Intended use

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

Quality statement

This product is manufactured, tested and released in compliance with the relevant GMP-guidelines. No animal- or human-derived materials were used during manufacturing. This product complies with USP chapter  “growth factors and cytokines used in cell therapy manufacturing”. USP chapter  “ancillary materials for cell, gene, and tissue-engineered products” has been considered in the design of this product.

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