GMP Human IL-15 Protein
GMP Platform Advantages
1. Quality Assurance: Global QMS with comprehensive and stringent QC release criteria.
2. End-to-End GMP Compliance: Full manufacturing and QC under a cGMP system.
3. Comprehensive Control of Adventitious Agents: Stringent biosafety from cell banks to final release.
4. Comprehensive Regulatory Support: Includes RSF and DMF to meet global requirements.
5. Resilient Supply Chain: Intelligent modular facilities ensure a stable global supply.
6. Professional Support: Extensive manufacturing and application expertise to accelerate development.
Source
GMP Human IL-15 Protein (GMP-L15H13) is expressed from E. coli cells. It contains AA Asn 49 - Ser 162 (Accession # P40933-1).
Molecular Characterization
This protein carries no "tag".
The protein has a calculated MW of 12.8 kDa. The protein migrates as 13 kDa±3 kDa under reducing (R) condition (SDS-PAGE).
N-terminal Sequence Analysis
Met-Asn-Trp-Val-Asn-Val-Ile-Ser-Asp-Leu-Lys-Lys-Ile-Glu-Asp
(Routinely tested)
Endotoxin
Less than 10 EU/mg, tested by the LAL method in compliance with USP <85> and Ph. Eur. 2.6.14.
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.
Sterility
Sterility testing was performed using the membrane filtration method in compliance with USP <71> and Ph. Eur. 2.6.1.
Mycoplasma
Negative
In vitro virus assay
Negative.
Purity
>95% as determined by SDS-PAGE.
Formulation
Lyophilized from 0.22 μm filtered solution in 25 mM His, pH6.2 with protectants.
Contact us for customized product form or formulation.
Vial Specification
2R (13 mm neck finish)
Shipping
This product is supplied and shipped with blue ice, please inquire the shipping cost.
Storage
Upon receipt, store it immediately at -20°C or lower for long term storage.
Please avoid repeated freeze-thaw cycles.
This product is stable after storage at:
-20°C to -70°C for 5 years in lyophilized state;
-70°C for 12 months under sterile conditions after reconstitution.
Background
Interleukin 15 is also known as IL15, IL-15, and is a cytokine with structural similarity to IL-2. Like IL-2, IL-15 binds to and signals through the IL-2/IL-15 beta chain (CD122) and the common gamma chain (gamma-C, CD132). IL-15 is secreted by mononuclear phagocytes (and some other cells) following infection by virus(es). This cytokine induces cell proliferation of natural killer cells; cells of the innate immune system whose principal role is to kill virally infected cells. Interleukin 15 (IL-15) regulates T and natural killer (NK) cell activation and proliferation. Survival signals that maintain memory T cells in the absence of antigen are provided by IL-15. This cytokine is also implicated in NK cell development. In rodent lymphocytes, IL-15 prevents apoptosis by inducing an apoptosis inhibitor, BCL2L1/BCL-x(L). IL-15 has been shown to enhance the anti-tumor immunity of CD8+ T cells in pre-clinical models. A phase I clinical trial to evaluate the safety, dosing, and anti-tumor efficacy of IL-15 in patients with metastatic melanoma and renal cell carcinoma (kidney cancer) has begun to enroll patients at the National Institutes of Health.
China
