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GMP Recombinant Human Granulocyte Macrophage-Colony Stimulating Factor (rh GM-CSF)重組人粒細胞刺激因子產(chǎn)品信息：
Data Sheet: CellGenix™
GMP Recombinant Human Granulocyte Macrophage-Colony Stimulating Factor (rh GM-CSF)
Order No.: 1012-050
Source
A DNA sequence encoding the mature GM-CSF protein (Cantrell,M. et al., 1985,PNAS 82:6250-6254; Lee, F. et al., 1985, PNAS 82:4360-4364; and Wong. et al.,1985, Science 228:810-815) was expressed in E. coli
Molecular mass
The methionyl form of the E. coli expressed mature human GM-CSF contains 128 amino acid residues and has a molecular mass of approximay 14.5 kDa
Identity
Confirmed by DNA-sequencing of the expression plasmid in end of production (EOP)-cells and N-terminal sequencing of the final product
Purity
≥97%, as determined by SDS-PAGE(under reducing and non-reducing conditions) and visualized by Coomassie staining
Endotoxin level
< 1000 EU/mg, as determined by LAL gel clot test according to Ph.Eur.typically < 100 EU/mg
Residual host-cell DNA
≤200 ng/mg, as determined by a fluorimetric assay
Activity
0.5x107–2.0x107IU/mg calibrated with the 1st International Standard NIBSC,# 88/646Measured 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)
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 anycarrier materials and preservatives
Amount per vial
50 ± 7.5 μg, as determined by spectrophotometrical measurement at 280 nmusing PBS as reference (A280= 0.96 for a concentration of 1 mg/ml GM-CSF inPBS)
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 therelevant GMP-guidelines. No animal- or human-derived materials were usedduring manufacturing. USP chapter <10
43> “ancillary materials for cell, gene,and tissue-engineered products” has been considered in the design of this product.
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