Recombinant Human IL-15 GMP Protein, CF GMP

Name: Recombinant Human IL-15 GMP Protein, CF
Brand: R&D Systems
SKU: 247-GMP

R&D Systems, part of Bio-Techne | Catalog # 247-GMP

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Product Datasheet / COA / SDS

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Product Specifications
Scientific Data
Preparation & Storage
Background
Product Documents
Manufacturing Specifications
Specific Notices

Key Product Details

Source

E. coli

Accession #

P40933.1

Conjugate

Unconjugated

Applications

Bioactivity

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Product Specifications

Source

E. coli-derived human IL-15 protein
Asn49-Ser162
Produced using non-animal reagents in an animal-free laboratory.
Manufactured and tested under current Good Manufacturing Practice (GMP) guidelines.

Purity

>97%, by SDS-PAGE with silver staining, under reducing conditions.

Endotoxin Level

<0.10 EU per 1 μg of the protein by the LAL method.

N-terminal Sequence Analysis

Asn-Trp-Val-Asn-Val-Ile-Ser-Asp-Leu-Lys

Predicted Molecular Mass

12.5 kDa

Activity

Measured in a cell proliferation assay using MO7e human megakaryocytic leukemic cells.
The ED₅₀ for this effect is 0.3-2.6 ng/mL.
The specific activity of recombinant human IL-15 is >2.0 x 10⁸ units/mg, which is calibrated against the human IL-15 reference standard (NIBSC code: 95/554).

Host Cell Protein

<0.5 ng per µg of protein when tested by ELISA.

Mycoplasma

Negative when tested in a ribosomal RNA hybridization assay.

Host Cell DNA

<0.010 ng per µg of protein when tested by PCR.

Scientific Data Images for Recombinant Human IL-15 GMP Protein, CF

Recombinant Human IL-15 GMP Protein Bioactivity

GMP-grade Recombinant Human IL-15 (Catalog # 247-GMP) stimulates cell proliferation in the MO7e human megakaryocytic leukemic cell line. The ED₅₀ for this effect is 0.3-2.6 ng/mL. Three independent lots were tested for activity and plotted on the same graph to show lot-to-lot consistency of GMP IL-15.

Recombinant Human IL-15 GMP Protein SDS-PAGE

1 μg/lane of GMP-grade Recombinant Human IL-15 (Catalog # 247-GMP) was resolved with SDS-PAGE under reducing (R) conditions and visualized by silver staining, showing a single band at 12 kDa.

Recombinant Human IL-15 GMP Protein Mass Spectrometry

MALDI-TOF analysis of GMP-grade Recombinant Human IL-15 (Catalog # 247-GMP). The major peak corresponds to the calculated molecular mass, 12774 Da. The minor peak at 13006 Da is a matrix-associated artifact of the MALDI-TOF.

Formulation, Preparation and Storage

247-GMP

Formulation	Lyophilized from a 0.2 μm filtered solution in PBS.
Reconstitution	Reconstitute at 100 μg/mL in PBS.
Shipping	The product is shipped with polar packs. Upon receipt, store it immediately at the temperature recommended below.
Stability & Storage	Use a manual defrost freezer and avoid repeated freeze-thaw cycles. A minimum of 12 months when stored at ≤ -20 °C as supplied. Refer to lot specific COA for the Use by Date. 1 month, 2 to 8 °C under sterile conditions after reconstitution. 3 months, ≤ -20 °C under sterile conditions after reconstitution.

Background: IL-15

Interleukin 15 (IL-15) is a widely expressed 14 kDa cytokine that is structurally and functionally related to IL-2 and plays an important role in many immunological diseases (1, 2). Mature human IL-15 shares 70% amino acid sequence identity with mouse and rat IL-15. Alternative splicing generates isoforms of IL-15 with either a long or short signal peptide (LSP or SSP), and the SSP isoform is retained intracellularly (3). IL-15 binds with high affinity to IL-15 R alpha (4). It binds with lower affinity to a complex of IL-2 R beta and the common gamma chain ( gammac) which are also subunits of the IL-2 receptor complex (5). IL-15 associates with IL-15 R alpha in the endoplasmic reticulum, and this complex is expressed on the cell surface (6). The dominant mechanism of IL-15 action is known as transpresentation in which IL-15 and IL-15 R alpha are coordinately expressed on the surface of one cell and interact with complexes of IL-2 R beta/ gammac on adjacent cells (7). This enables cells to respond to IL-15 even if they do not express IL-15 R alpha (6). In human and mouse, soluble IL-15-binding forms of IL-15 R alpha can be generated by proteolytic shedding and bind up nearly all the IL-15 in circulation (8-10). Soluble IL-15 R alpha functions as an inhibitor that limits IL-15 action (4, 9). Ligation of membrane-associated IL-15/IL-15 R alpha complexes also induces reverse signaling that promotes activation of the IL-15/IL-15 R alpha expressing cells (11). IL-15 induces or enhances the differentiation, maintenance, or activation of multiple T cell subsets including NK, NKT, Th17, Treg, and CD8⁺ memory cells (12 - 16). An important component of these functions is the ability of
IL-15 to induce dendritic cell differentiation and inflammatory activation (11, 14). IL-15 exhibits anti-tumor activity independent of its actions on NK cells or CD8⁺ T cells (17). It also inhibits the deposition of lipid in adipocytes, and its circulating levels are decreased in obesity (18).

References

De Sabatino, A. et al. (2011) Cytokine Growth Factor Rev. 22:19.
Grabstein, K. et al. (1994) Science 264:965.
Tagaya, Y. et al. (1997) Proc. Natl. Acad. Sci. USA 94:14444.
Giri, J.G. et al. (1995) EMBO J. 14:3654.
Giri, J. et al. (1994) EMBO J. 13:2822.
Dubois, S. et al. (2002) Immunity 17:537.
Castillo, E.F. and K.S. Schluns (2012) Cytokine 59:479.
Budagian, V. et al. (2004) J. Biol. Chem. 279:40368.
Mortier, E. et al. (2004) J. Immunol. 173:1681.
Bergamaschi, C. et al. (2012) Blood 120:e1.
Budagian, V. et al. (2004) J. Biol. Chem. 279:42192.
Mortier, E. et al. (2003) J. Exp. Med. 205:1213.
Gordy, L.E. et al. (2011) J. Immunol. 187:6335.
Harris, K.M. (2011) J. Leukoc. Biol. 90:727.
Xia, J. et al. (2010) Clin. Immunol. 134:130.
Schluns, K.S. et al. (2002) J. Immunol. 168:4827.
Davies, E. et al. (2010) J. Leukoc. Biol. 88:529.
Barra, N.G. et al. (2010) Obesity 18:1601.

Long Name

Interleukin 15

Alternate Names

IL15

Entrez Gene IDs

3600 (Human); 16168 (Mouse); 25670 (Rat); 102119613 (Cynomolgus Monkey); 493682 (Feline)

Gene Symbol

IL15

UniProt

P40933.1

Additional IL-15 Products

Product Documents for Recombinant Human IL-15 GMP Protein, CF

Product Datasheets

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COA

SDS

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Manufacturing Specifications

GMP Proteins
R&D Systems, a Bio-Techne Brand's GMP proteins are produced according to relevant sections of the following documents: USP Chapter 1043, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and Eu. Ph. 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.

R&D Systems' quality focus includes:

Manufactured and tested under an ISO 9001:2015 and ISO 13485:2016 certified quality system
Documented processes and QA control of documentation and process changes
Personnel training programs
Raw material testing and vendor qualification/monitoring
Fully validated equipment, processes and test methods
Equipment calibration schedules using a computerized calibration program
Facility maintenance, safety programs and pest control
Material review process for variances
Monitoring of stability over product shelf-life

R&D Systems strives to provide our customers with the analytical characteristics of each product so that customers may determine whether our products are appropriate for their research. The Certificate of Analysis provided contains the following lot specific information:

N-terminal amino acid analysis, SDS-PAGE analysis, and endotoxin level (as determined by LAL assay) performed on each bulk QC lot, not on individual bottlings of each QC lot
Post-bottling lot-specific bioassay results (compliance with an established range) and results of microbial testing according to USP
Host Cell Protein testing performed by ELISA
Mycoplasma testing by ribosomal RNA hybridization assay

Additional testing and documentation requested by the customer can be arranged at an additional cost.

Production records and facilities are available for examination by appropriate personnel on-site at R&D Systems in Minneapolis, Minnesota USA.

R&D Systems sells GMP grade products for preclinical or clinical ex vivo use. They are not for in vivo use. Please read the following End User Terms prior to using this product.

Animal-Free Manufacturing Conditions
Our dedicated controlled-access animal-free laboratories ensure that at no point in production are the products exposed to potential contamination by animal components or byproducts. Every stage of manufacturing is conducted in compliance with R&D Systems' stringent Standard Operating Procedures (SOPs). Production and purification procedures use equipment and media that are confirmed animal-free.

Production

All molecular biology procedures use animal-free media and dedicated labware.
Dedicated fermentors are utilized in committed animal-free areas.

Purification

Protein purification columns are animal-free.
Bulk proteins are filtered using animal-free filters.
Purified proteins are stored in animal-free containers in a dedicated cold storage room.

Quality Assurance

Low Endotoxin Level.
No impairment of biological activity.
High quality product obtained under stringent conditions.

Please read our complete Animal-Free Statement

Product Specific Notices for Recombinant Human IL-15 GMP Protein, CF

END USER TERMS OF USE OF PRODUCT

The following terms are offered to you upon your acceptance of these End User Terms of Use of Product. By using this product, you indicate your acknowledgment and agreement to these End User Terms of Use of Product. If you do not agree to be bound by and comply with all of the provisions of these End User Terms of Use of Product, you should contact your supplier of the product and make arrangements to return the product.

We suggest you print and retain a copy of these End User Terms of Use of Product for your records.

The End User is aware that R&D Systems, Inc. sells GMP products for preclinical or clinical ex vivo use and not for in vivo use. The End User further agrees, as a condition of the sale of R&D Systems' GMP products that: a) the End User will not use this GMP Product in any procedure wherein the product may be directly or indirectly administered to humans, unless the End User has obtained, or prior to their use will have obtained, an Investigational New Drug (IND) exemption from the FDA and will use the product only in accordance with the protocols of such IND and of the Institutional Review Board overseeing the proposed research, or b) the End User will use the products outside of the United States in accordance with the protocols of research approved by the Institutional Review Board or authorized ethics committee and regulatory agencies to which the End User is subject to in their territory.

R&D Systems, Inc. has the right, at its sole discretion, to modify, add or remove any terms or conditions of these End User Terms of Use without notice or liability to you. Any changes to these End User Terms of Use are effective immediately following the printing of such changes on this product insert. The most recent version of these End User Terms of Use of Product may be found at: RnDSystems.com/Legal.

You agree to review these End User Terms of Use of Product to ensure any subsequent use by you of R&D Systems' GMP Products following changes to these End User Terms of Use of Product constitutes your acceptance of all such changes.

TERMS AND CONDITIONS

The following limitation applies to R&D Systems' warranty and liability for damages: All products are warranted to meet R&D Systems' published specifications when used under normal laboratory conditions.

R&D SYSTEMS DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO ITS PRODUCTS. IN PARTICULAR, R&D SYSTEMS DOES NOT MAKE ANY WARRANTY OF SUITABILITY, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

NOTWITHSTANDING ANY OTHER PROVISIONS OF THESE TERMS AND/OR ANY OTHER AGREEMENT BETWEEN R&D SYSTEMS AND PURCHASER FOR THE PURCHASE OF THE PRODUCTS, R&D SYSTEMS' TOTAL LIABILITY TO PURCHASER ARISING FROM OR IN RELATION TO THESE TERMS, AN AGREEMENT BETWEEN THE PARTIES OR THE PRODUCTS, WHETHER ARISING IN CONTRACT, TORT OR OTHERWISE SHALL BE LIMITED TO THE TOTAL AMOUNT PAID BY PURCHASER TO R&D SYSTEMS FOR THE APPLICABLE PRODUCTS. IN NO EVENT WILL R&D SYSTEMS BE LIABLE FOR THE COST OF PROCUREMENT OF SUBSTITUTE GOODS.

Full details of R&D Systems' Terms and Conditions of Sale can be found online at: RnDSystems.com/Legal.

For preclinical, or clinical ex vivo use

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