Liquid GMP-grade human IL-2 protein

Interleukin-2 (IL-2) is a cytokine, a type of immune system signaling molecule, that plays a crucial role in the body's defense against microbial infections and distinguishing between self and non-self. IL-2 exerts its effects by binding to IL-2 receptors, which are expressed on lymphocytes—the immune cells responsible for maintaining immunity.

Mature human IL-2 shares 56% and 66% amino acid sequence identity with mouse and rat IL-2, respectively, and human and mouse IL-2 demonstrate cross-species activity. The IL-2 receptor comprises three subunits in different preformed complexes on the cell surface.

IL-2 is also essential for T cell development in the thymus, particularly in the maturation of regulatory T cells (T-regs). Once these cells exit the thymus, they help prevent autoimmunity by inhibiting other T cells from recognizing and attacking self-antigens. They achieve this by suppressing the production of IL-2 in responding cells. This function highlights IL-2’s critical role in maintaining immune balance and ensuring proper self-tolerance.

Features

  • Developed in compliance with ISO 9001:2015 and ISO 13485:2016 standards
  • Undergoes rigorous quality control testing
  • Ensures batch-to-batch consistency
  • Produced and quality control (QC) tested in a GMP-compliant facility
  • Animal-free materials
  • Free from beta-lactam components

Source

The GMP Human IL-2 Protein (Liquid) (GMP-L02H14F002) is expressed in E. coli cells. It includes amino acids Ala 21 to Thr 153 (Accession # P60568-1).

Predicted N-terminus: Met

Molecular characterization

Liquid GMP-grade human IL-2 protein

Image Credit: ACROBiosystems Inc

This protein is untagged.

The calculated molecular weight (MW) is 15.4 kDa. When analyzed under reducing conditions (SDS-PAGE) and calibrated against the Star Ribbon Pre-stained Protein Marker, the protein migrates at approximately 16 kDa ± 2 kDa.

Endotoxin

Contains less than 25 EU per vial, as determined by the LAL method.

Host cell protein

Contains less than 0.5 ng/µg of protein, as tested by ELISA.

Host cell DNA

Contains less than 0.1 ng/μg of protein, as tested by qPCR.

Sterility

Sterility testing was conducted using the membrane filtration method, following the guidelines in CP<1101>, USP<71>, and Eur. Ph. 2.6.1.

Mycoplasma

Tested negative for mycoplasma contamination.

Purity

Purity exceeds 95%, as determined by SDS-PAGE analysis.

Formulation

Supplied as a 0.2 μm filtered solution in phosphate buffer with protectants.

Shipping

The product is shipped on dry ice.

Storage

Avoid repeated freeze-thaw cycles.

Storage conditions:

  • Must be stored at -70 °C or lower upon receipt.
  • Stable for 24 months at -70 °C under sterile conditions.

ACRO quality management system

  • QMS (ISO, GMP)
  • Quality Advantages
  • Quality Control Process

QC and assay protocol

SDS-PAGE

GMP Human IL-2 Protein (Liquid) in reducing (R) conditions on SDS-PAGE. Coomassie Blue was used to stain the gel. With the Star Ribbon Pre-stained Protein Marker, the protein's purity is higher than 95%.

Liquid GMP-grade human IL-2 protein

Image Credit: ACROBiosystems Inc

Bioactivity-Bioactivity CELL BASE

The GMP Human IL-2 Protein (Liquid) (Cat. No. GMP-L02H14F002) promotes CTLL-2 cell proliferation. When compared to the human Interleukin-2 China National Standard (NIFDC code: 270008), the specific activity of GMP Human IL-2 Protein (Liquid) is ≥ 1.20 × 107 IU/mg (QC tested).

The human IL-2 WHO International Standard (NIBSC code: 86/500) was used to prepare and calibrate the China National Institutes for Food and Drug Control (NIFDC) Standard.

Liquid GMP-grade human IL-2 protein

Image Credit: ACROBiosystems Inc

Bioactivity-Stability

GMP Human IL-2 Protein (Liquid) (Cat. No. GMP-L02H14F002) is stable at 25 °C for 65 hours, according to the cell-based assay.

Liquid GMP-grade human IL-2 protein

Image Credit: ACROBiosystems Inc

According to the cell-based assay, GMP Human IL-2 Protein (Liquid) (Cat. No. GMP-L02H14F002) is stable after three freezing and thawing cycles.

Liquid GMP-grade human IL-2 protein

Image Credit: ACROBiosystems Inc

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