Cat Number: GMP-101-02

rHuIL-2 GMP

Inquiry

Source

Escherichia coli

Purity

> 98% by SDS-PAGE and HPLC analyses.

Molecular Weight

Approximately 15.4 kDa, a single non-glycosylated polypeptide chain containing 133 amino acids.

Sequence

APTSSSTKKT QLQLEHLLLD LQMILNGINN YKNPKLTRML TFKFYMPKKA TELKHLQCLE EELKPLEEVL NLAQSKNFHL RPRDLISNIN VIVLELKGSE TTFMCEYADE TATIVEFLNR WITFCQSIIS TLT

Biological Activity

Fully biologically active when compared to standard. Measured in a cell proliferation assay using CTLL-2 cells. The specific activity of recombinant human IL-2 is > 1.0 × 107 IU/mg, which is calibrated against rHuIL-2 WHO International Standard (NIBSC code: 86/500).

Appearance

Sterile filtered white lyophilized (freeze-dried) powder.

Formulation

Lyophilized from a 0.2 µm filtered concentrated solution in 20 mM PB, pH 3.5.

Stability & Storage

Use a manual defrost freezer and avoid repeated freeze-thaw cycles.
- A minimum of 12 months from date of receipt, when stored at ≤ -20 °C as supplied.
- 1 month, 2 to 8 °C under sterile conditions after reconstitution.
- 3 months, -20 to -70 °C under sterile conditions after reconstitution.
- Refer to lot-specific CoA for the Expiry Date.

Shipping

The product is shipped with polar packs. Upon receipt, store it immediately at the temperature recommended below.

Endotoxin

Less than 0.01 EU/µg of rHuIL-2 GMP as determined by LAL method.

Host Cell Protein

Less than 0.05% when tested by ELISA.

Host Cell DNA

Less than 20 ng/mg when tested by qPCR.

Reconstitution

Prior to opening, it is recommended to centrifuge the vial briefly to bring the contents down the bottom. Reconstitute in sterile distilled water to a concentration of 0.1-1.0 mg/mL. If animal-origin-free condition is expected in your product, then sterile distilled water is recommended. Stock solutions should be apportioned into working aliquots and stored at ≤ -20 °C. Further dilutions should be made in appropriate buffered solutions. Do not reconstitute in cell culture media directly.

Usage

This material is offered by Shanghai PrimeGene Bio-Tech for research, laboratory, or further evaluation purposes. NOT FOR HUMAN USE.

Quality Statement

The manufacturing and testing of these products comply with ICH Q7 guidelines.

Sterility

Negative

Mycoplasma

Negative

In Vitro Virus Assay

Negative

Standard

5μg, 100μg

Background

IL-2 is a powerful immunoregulatory lymphokine produced by T-cells in response to antigenic or mitogenic stimulation. It is expressed by CD4+ and CD8+ T cells, γδ T cells, B cells, dendritic cells, and eosinophils. IL-2/IL-2R signaling is required for T-cell proliferation and other fundamental functions which are essential for the immune response. The receptor for IL-2 consists of three subunits (55 kDa IL2Rα, 75 kDa IL2Rβ, 64 kDa common gamma chain γc/IL2Rγ) that are present on the cell surface in varying preformed complexes. Mature human IL-2 shares 56% and 66% amino acid sequence identity with mouse and rat IL-2, respectively. Human and mouse IL-2 exhibit cross-species activity.