GMP Human IL-2 Protein
Catalog # GMP-L02H14

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-2 Protein(GMP-L02H14) is expressed from E. coli cells. Itcontains AA Ala 21 - Thr 153 (Accession # P60568-1).
Predicted N-terminus: Met

Molecular Characterization

Lyophilized from 0.22 μm filtered solution in phosphate 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 15.4 kDa. The protein migrates as 16 kDa±2

Please avoid repeated freeze-thaw cycles.

kDa when calibrated against Star Ribbon Pre-stained Protein Marker underThis product is stable after storage at:

reducing (R) condition (SDS-PAGE).

-20°C for 5 years in lyophilized state;

Endotoxin-70°C for 12 months under sterile conditions after reconstitution.

Less than 5.0 EU/ Vial by the LAL method.

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

Host Cell DNA<0.1 ng/μg of protein tested by qPCR.

SDS-PAGE

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9/30/2024

GMP Human IL-2 Protein
Catalog # GMP-L02H14

GMP Human IL-2 Protein on SDS-PAGE under reducing (R) condition. Thegel was stained with Coomassie Blue. The purity of the protein is greater than
95% (With Star Ribbon Pre-stained Protein Marker).

Bioactivity-Bioactivity CELL BASE

GMP Human IL-2 Protein (Cat. No. GMP-L02H14) stimulates proliferation ofCTLL-2 cells. The specific activity of GMP Human IL-2 Protein is ≥1.20×10^7 IU/mg, which is calibrated against human Interleukin-2 China
National Standard (NIFDC code: 270008) (QC tested). China National
Institutes for Food and Drug Control (NIFDC) Standard was prepared andcalibrated against human IL-2 WHO International Standard (NIBSC code:86/500) by NIFDC.

Application Data

3 × 10^6 Human PBMCs were cultured with various concentrations of GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) or IL-2 Protein(Competitor N) for a week. For the negative control group (w/o IL-2), the CD3+ ratio was 47.6%, and the CD3+ cell number was 4.8 × 10^5. The result shows that
GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) has a similar activity to IL-2 Protein (Competitor N).

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9/30/2024GMP Human IL-2 Protein
Catalog # GMP-L02H14

3 × 10^6 Human PBMCs were cultured with various concentrations of GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) or IL-2 Protein(Competitor N) for a week. For negative control group (w/o IL-2), the CD3+ CD4- CD8+ ratio was 21.7%, and the CD3+ CD4- CD8+ cell number was 1.0 × 10^5.
The result shows that GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) has a similar activity to IL-2 Protein (Competitor N).

3 × 10^6 Human PBMCs were cultured with various concentrations of GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) or IL-2 Protein(Competitor N) for a week. For negative control group (w/o IL-2), the CD3+ CD4+ CD8- ratio was 72.4%, and the CD3+ CD4+ CD8- cell number was 3.5 × 10^5.
The result shows that GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) has a similar activity to IL-2 Protein (Competitor N).

Bioactivity-Stability

The Cell based assay shows that GMP Human IL-2 Protein (Cat. No. GMPL02H14) is stable at 37°C for 8 hours.
The Cell based assay shows that GMP Human IL-2 Protein (Cat. No. GMPL02H14) is stable in the quality of different batches.

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9/30/2024

GMP Human IL-2 Protein
Catalog # GMP-L02H14

The Cell based assay shows that GMP Human IL-2 (Cat. No. GMP-L02H14) isstable after freezing and thawing 3 times.

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 equipmentQualified 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

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9/30/2024

GMP Human IL-2 Protein
Catalog # GMP-L02H14

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

Background
Interleukin-2 (IL-2) is an interleukin, a type of cytokine immune system signaling molecule, which is a leukocytotrophic hormone that is instrumental in the body's
natural response to microbial infection and in discriminating between foreign (non-self) and self. IL-2 mediates its effects by binding to IL-2 receptors, which areexpressed by lymphocytes, the cells that are responsible for immunity. Mature human IL-2 shares 56% and 66% aa sequence identity with mouse and rat IL-2,respectively. Human and mouse IL-2 exhibit crossspecies activity. The receptor for IL-2 consists of three subunits that are present on the cell surface in varying
preformed complexes. IL-2 is also necessary during T cell development in the thymus for the maturation of a unique subset of T cells that are termed regulatory Tcells (T-regs). After exiting from the thymus, T-Regs function to prevent other T cells from recognizing and reacting against "self antigens", which could result in"autoimmunity". T-Regs do so by preventing the responding cells from producing IL-2. Thus, IL-2 is required to discriminate between self and non-self, another oneof the unique characteristics of the immune system.

Clinical and Translational Updates

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9/30/2024