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 1^st 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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