GMP Human IL-7 Protein
Catalog # GMP-L07H24

Features

Sterility

Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
FDA DMF filed

The sterility testing was performed by membrane filtration method described in
CP<1101>, USP<71> and Eur. Ph. 2.6.1.

Mycoplasma
Negative.

Animal-Free materials
Beta-lactam materials free
Batch-to-batch consistency

In vitro virus assay
Negative.

PurityStringent quality control tests>95% as determined by SDS-PAGE.

SourceGMP Human IL-7 Protein(GMP-L07H24) is expressed from human 293 cells(HEK293). It contains AA Asp 26 - His 177 (Accession # P13232-1).
Predicted N-terminus: Asp 26

Molecular Characterization

Formulation
Lyophilized from 0.22 μm filtered solution in PBS, pH7.4 with protectants.
Contact us for customized product form or formulation.

Shipping
This product is supplied and shipped with blue ice, please inquire the shipping
cost.
This protein carries no "tag".
The protein has a calculated MW of 17.4 kDa. The protein migrates as 23 kDa
and 28 kDa (±3 kDa) under reducing (R) condition (SDS-PAGE) due toStorage
Upon receipt, store it immediately at -20°C or lower for long term storage.

glycosylation.

Please avoid repeated freeze-thaw cycles.

Endotoxin

This product is stable after storage at:

Less than 10 EU/mg by the LAL method.

-20°C to -70°C for 5 years in lyophilized state;-70°C for 12 months under sterile conditions after reconstitution.

Host Cell Protein<0.5 ng/µg of protein tested by ELISA.

Host Cell DNA<0.02 ng/μg of protein tested by DNA Fluorescent Staining method.

SDS-PAGE

www.acrobiosystems.com

9/18/2024

GMP Human IL-7 Protein
Catalog # GMP-L07H24

GMP Human IL-7 Protein on SDS-PAGE under reducing (R) condition. Thegel was stained with Coomassie Blue. The purity of the protein is greater than95%.

Bioactivity-Bioactivity CELL BASE

GMP Human IL-7 Protein (Cat. No. GMP-L07H24) stimulates proliferation of

The activity of GMP Human IL-7 Protein (Cat. No. GMP-L07H24) was higher

PHA-P-activated human peripheral blood mononuclear cell (PBMC). The

than other competing products.

specific activity of GMP Human IL-7 is > 1.00×10^8 IU/mg, which iscalibrated against human IL-7 WHO International Standard (NIBSC code:90/530) (QC tested).

Bioactivity-Stability

The Cell based assay shows that GMP Human IL-7 Protein (Cat. No. GMP-

The Cell based assay shows that GMP Human IL-7 Protein (Cat. No. GMP-

L07H24) is stable at 37°C for 48 hours.

L07H24) is stable at 4℃ for 6 months in 4℃ real time stability experiment.

www.acrobiosystems.com

9/18/2024

GMP Human IL-7 Protein
Catalog # GMP-L07H24

The Cell based assay shows that GMP Human IL-7 Protein (Cat. No. GMP-

The Cell based assay shows batch-to-batch consistency between Acro's GMP

L07H24) is stable after freezing and thawing 3 times.

and PG IL-7.

MANUFACTURING SPECIFICATIONSACROBiosystems GMP grade products are produced under a quality management system and in compliance with relevant guidelines: Ph. Eur General Chapter
5.2.12 Raw materials of biological origin for the production of cell-based and gene therapy medicinal products; USP<92>Growth Factors and Cytokines Used in Cell
Therapy Manufacturing; USP<1043>Ancillary Materials for Cell, Gene, and Tissue-Engineered Products; ISO/TS 20399-1:2018, Biotechnology - Ancillary
Materials Present During the Production of Cellular Therapeutic Products.

ACROBiosystems Quality Management System Contents：
Designed under ISO 9001:2015 and ISO 13485:2016, Manufactured and QC tested under a GMP compliance factory.
Animal-Free materials
Materials purchased from the approved suppliers by QA
ISO 5 clean rooms and automatic filling equipment
Qualified personnel
Quality-related documents review and approve by QA
Fully batch production and control records
Equipment maintenance and calibration
Validation of analytical procedures
Stability studies conducted
Comprehensive regulatory support files
Request For Regulatory Support Files（RSF）

ACROBiosystems provide rigorous quality control tests (fully validated equipment, processes and test methods) on our GMP grade products to ensure that they meetstringent standards in terms of purity, safety, activity and inter-batch stability, and each bulk QC lot mainly contains the following specific information:
SDS-PAGE
Protein content
Endotoxin level

www.acrobiosystems.com

9/18/2024

GMP Human IL-7 Protein
Catalog # GMP-L07H24

Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysis
Microbial testingMycoplasma testingIn vitro virus assay
Residual moisture
Batch-to-batch consistency

Background
Interleukin 7 is also known as IL7, IL-7, and is a hematopoietic growth factor secreted by stromal cells in the red marrow and thymus. It is also produced bykeratinocytes, dendritic cells, hepatocytes, neurons, and epithelial cells, but is not produced by lymphocytes. IL-7 stimulates the differentiation of multipotent(pluripotent) hematopoietic stem cells into lymphoid progenitor cells, It also stimulates proliferation of all cells in the lymphoid lineage (B cells, T cells and NKcells). It is important for proliferation during certain stages of B-cell maturation, T and NK cell survival, development and homeostasis. IL-7 is a cytokine importantfor B and T cell development. This cytokine and the hepatocyte growth factor (HGF) form a heterodimer that functions as a pre-pro-B cell growth-stimulating factor.
IL-7 binds to the IL-7 receptor, a heterodimer consisting of Interleukin-7 receptor alpha and common gamma chain receptor. Il-7 promotes hematological malignacies(acute lymphoblastic leukemia, T cell lymphoma). Elevated levels of IL-7 have also been detected in the plasma of HIV-infected patients. IL-7 as an immunotherapy
agent has been examined in many pre-clinical animal studies and more recently in human clinical trials for various malignancies and during HIV infection. IL-7
could also be beneficial in improving immune recovery after allogenic stem cell transplant.

Clinical and Translational Updates

www.acrobiosystems.com

9/18/2024