Recombinant Human Interleukin-4

CERTIFICATE OF ANALYSIS

Source E.coli
Appearance Colourless, clear liquid free of particles
Identity 1 band at 15kDa as measured by SDS-PAGE/Western Blot
Specific activity 12.4 x 10 exp6 units / mg compared to NIBSC standard (Bioassay)
Endotoxin content < 0.1EU/µg (LAL)
Protein content 50±10 µg/vial (Lowry/µBCA)
Trehalose 6±0.5 mg/ml (HPLC)
Sterility Absence of growth (FTM (30-35°C)) / Absence of growth (TSB (20-25°C))
Abnormal toxicity No weight loss, no abnormal reaction in mice
General Growth No weight loss, no abnormal reaction in guinea pigs
Physical state Freeze-dried
Stability 12 months at -20°C to -80°C
At least 3 months after reconstruction when stored at -20°C to -80°C
Reconstruction Use 500µL water for injection
Packaging unit 50 µg protein (Lowry test)
Purity >98% as determined by SDS-PAGE and HPLC

 

GMP certification: GENTAUR rh IL-4 is manufactured in full compliance with cGMP in facilities approved by the Belgian Ministry of Health for the production and storage of medicinal products. The manufacturing process does not involve the use of products of animal origin.

BSE/TSE Declaration: GENTAUR BVBA declares that this recombinant human IL-4 (04-GMPhuIL4) is manufactured under strict GMP controls and certifies that the entire product line is BSE (Bovine Spongiform Encephalopathy) and TSE (Transmissible Spongiform Encephalopathy) free. GENTAUR BVBA manufactures this product in Belgium.

Use GENTAUR rh IL-4 is not an approved medicinal product and ONLY be injected as such to patients after the ethical commission approval of your university.

More information:

Recombinant Human InterleukiF.pdf
IL4 detail.pdf
rHuIL-4.pdf

For More Information Contact us 

     

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