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GMP Recombinant Human Interleukin-4 (rh IL-4), USP grade USP級人重組白介素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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