GMP Recombinant Human Interleukin-4
Catalog #: 04-GMPhuIL4-50 µg
( rHuIL-4) 50 µg
GMP Certificate of Analysis and Material Safety Data Sheet
Lotnr GMP-IL4: Lot# 017/LC/030526/PV
Activity : 13 x 10**6 U /mg or 6.5 x 10**5 U/ 50 ug
Expyry date: If stored at -20°C stable for 3 years after last test date.
(last test date is 09/2006 by Brucells SA)
Description: Recombinant Human IL-4 produced in E.Coli is a single, non-glycosylated polypeptide chain containing
130 amino acids and having a molecular mass of 15000 Dalton. The rHuIL-4 is purified by proprietary chromatographic
Source : E.coli
Molecular weight : 15 KDa
Identity : rh IL-4 as measured by Elisa and Western Blot
Specific activity :12.5 10 6 units/mg compared to NIBSC standard . CT-h4.S cell
Purity : > 98% as determined by SDS-PAGE and HPLC
Endotoxin content : < 0.1 EU/ µg of IL-4 (LAL test)
Host DNA : < 10 pg/ng protein
Sterility : sterile according to EP Test 2.6.1.
Stabiliser : contains Trehalose ; no preservative.
Physical state : freeze-dried
Stability : 36 months at – 20°C to – 80°C
3 months after reconstitution with water for injection (as defined in EP
Monograph 0169) when stored at -80°C
Reconstitution : use 500 µL water for injection in class A environment in order to keep the GMP grade .
Packaging unit : 50 µg protein (Lowry test)
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. GMP production at HENOGEN SA and GMP Lyophilisation at GSK Inc, Rixensart.
BRUcELLS rh IL-4 is not an approved medicinal product and cannot be injected as such to patients. However this GMP IL-4 is used in clinical tests for DC Therapy today in Belgium, France, Denmark, USA and Japan.
CE CERTIFIED FOR EX VIVO CELL CULTURE AND DC THERAPY CLINICAL TESTS
Copyright © 2002 GENTAUR Molecular Products