GMP Human IL-4 Protein
Catalog # GMP-L04H26

Features

Sterility

Designed under ISO 9001:2015 and ISO 13485:2016
Manufactured and QC tested under a GMP compliance factory
Animal-Free materials
Beta-lactam materials free

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

Mycoplasma
Negative.

PurityBatch-to-batch consistency
Stringent quality control tests>95% as determined by SDS-PAGE.

Formulation

SourceGMP Human IL-4 Protein(GMP-L04H26) is expressed from human 293 cells(HEK293). It contains AA His 25 - Ser 153 (Accession # P05112-1).
Predicted N-terminus: His 25

Molecular Characterization

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.

Storage
This protein carries no "tag".

Upon receipt, store it immediately at -20°C or lower for long term storage.

The protein has a calculated MW of 15.0 kDa. The protein migrates as 19 kDa±3

Please avoid repeated freeze-thaw cycles.

kDa under reducing (R) condition (SDS-PAGE) due to glycosylation.

This product is stable after storage at:-20°C to -70°C for 5 years in lyophilized state;

Endotoxin
Less than 10 EU/mg by the LAL method.

-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 qPCR.

SDS-PAGE

GMP Human IL-4 Protein on SDS-PAGE under reducing (R) condition. The
gel was stained with Coomassie Blue. The purity of the protein is greater thanwww.acrobiosystems.com

9/18/2024

GMP Human IL-4 Protein
Catalog # GMP-L04H26

95%.

Bioactivity-Bioactivity CELL BASE

GMP Human IL-4 Protein (Cat. No. GMP-L04H26) stimulates proliferation of

The activity of GMP Human IL-4 Protein (Cat. No. GMP-L04H26) was higher

TF-1 human erythroleukemic cell line. The specific activity of GMP Humanthan other competing products.

IL-4 Protein is > 1.20×10^7 IU/mg, which is calibrated against human IL-4
WHO International Standard (NIBSC code: 88/656) (QC tested).

Bioactivity-Stability

The Cell based assay shows that GMP Human IL-4 Protein (Cat. No. GMPThe Cell based assay shows that GMP Human IL-4 Protein (Cat. No. GMP-

L04H26) is stable at 4℃ for 180 days.

L04H26) is stable at 37℃ for 24 hours.

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9/18/2024

GMP Human IL-4 Protein
Catalog # GMP-L04H26

The Cell based assay shows that GMP Human IL-4 Protein (Cat. No. GMP-

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

L04H26) is stable after freezing and thawing 3 times.

and PG IL-4.

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
Residual Host Cell DNA content
Residual Host Cell Protein content
Biological activity analysis
Microbial testing
Mycoplasma testingIn vitro virus assay
Residual moisture
Batch-to-batch consistencywww.acrobiosystems.com

9/18/2024

GMP Human IL-4 Protein
Catalog # GMP-L04H26

Background
Interleukin-4, is a cytokine that induces differentiation of naive helper T cells (Th0 cells to Th2 cells). In the presence of IL-4 and IL-13, cytokines that are produced
in a Th-2 type response, particularly during allergy and parasitic infections, macrophages become differentially activated, And this cytokine is a ligand for interleukin
4 receptor. The interleukin 4 receptor also binds to IL13, which may contribute to many overlapping functions of this cytokine and IL13. STAT6, a signal transducer
and activator of transcription, has been shown to play a central role in mediating the immune regulatory signal of this cytokine. Recently, researcher found that thecytokine IL-4 plays a key role in development of innate CD8+ T cells in the thymus of several gene-deficient mouse strains, including Itk, KLF2, CBP and Id3,
without previous exposure to antigen.

Clinical and Translational Updates

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9/18/2024