ACRO ensures that its human IL-7 proteins meet GMP standards through rigorous QC testing.
Features
- Designed in accordance with ISO 9001:2015 and ISO 13485:2016 standards
- Manufactured and quality control tested in a GMP-compliant facility
- Ensures batch-to-batch consistency
- FDA DMF filed
- Produced using animal-free materials
- Free from beta-lactam materials
- Subjected to stringent quality control tests
Source
GMP Human IL-7 Protein (GMP-L07H24) is expressed in human 293 cells (HEK293) and contains amino acids Asp 26 to His 177 (Accession # P13232-1).
Predicted N-terminus: Asp 26
Molecular characterization
Image Credit: ACROBiosystems Inc
This protein carries no "tag".
The protein has a calculated molecular weight of 17.4 kDa and migrates as 23 kDa and 28 kDa (±3 kDa) under reducing conditions (SDS-PAGE) due to glycosylation.
Endotoxin
Levels were less than 10 EU/mg as ascertained by the LAL method.
Host cell protein
ELISA shows <0.5 ng/µg of protein
Host cell DNA
DNA Fluorescent Staining method reveals <0.02 ng/μg of protein.
Sterility
Sterility testing was performed using the membrane filtration method in accordance with CP<1101>, USP<71>, and Eur. Ph. 2.6.1.
Mycoplasma
Negative.
In vitro virus assay
Negative.
Purity
Purity is >95% as determined by SDS-PAGE.
Formulation
Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with protectants.
Shipping
This product is supplied and shipped with blue ice.
Storage
Upon receipt, store it immediately at -20°C or lower for long-term storage.
Repeated freeze-thaw cycles should be avoided.
This product is stable when stored at:
- -20 °C to -70 °C for 5 years in lyophilized form
- -70 °C for 12 months under sterile conditions after reconstitution.
ACRO quality management system
- Quality Advantages
- QMS（ISO, GMP）
- Quality Control Process
QC and assay protocol
SDS-PAGE
Image Credit: ACROBiosystems Inc
The GMP Human IL-7 Protein, when analyzed on SDS-PAGE under reducing (R) conditions and stained with Coomassie Blue, shows a purity greater than 95%.
Bioactivity-bioactivity CELL BASE
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GMP Human IL-7 Protein (Cat. No. GMP-L07H24) stimulates PHA-P-activated human peripheral blood mononuclear cells (PBMC) proliferation. The specific activity of GMP Human IL-7 is >1.00 × 108 IU/mg, calibrated against the human IL-7 WHO International Standard (NIBSC code: 90/530), and is QC tested.
Image Credit: ACROBiosystems Inc
The activity of GMP Human IL-7 Protein (Cat. No. GMP-L07H24) surpasses that of other competing products.
Bioactivity-Stability
Image Credit: ACROBiosystems Inc
Cell-based assays demonstrate that GMP Human IL-7 Protein (Cat. No. GMP-L07H24) remains stable at 37 °C for up to 48 hours.
Image Credit: ACROBiosystems Inc
The Cell based assay reveals that GMP Human IL-7 Protein (Cat. No. GMP-L07H24) maintains stability at 4 ℃ for 6 months in 4 ℃ real time stability experiment.
Image Credit: ACROBiosystems Inc
Cell-based assays indicate that GMP Human IL-7 Protein (Cat. No. GMP-L07H24) remains stable after being frozen and thawed three times.
Image Credit: ACROBiosystems Inc
The cell-based assay demonstrates batch-to-batch consistency between ACRO's GMP and PG IL-7 products.