Recombinant Human IL-15 GMP Protein, CF

Name: Recombinant Human IL-15 GMP Protein, CF
Brand: R&D Systems
SKU: BT-015-GMP
Price: 874 USD

Catalog #: BT-015-GMP Datasheet / COA / SDS

New! Bypass reconstitution steps by using a liquid formulation of GMP-grade Recombinant Human IL-15. Find out more here.

Animal-Free

Single Use Lyophilized Vial

Catalog #	Availability	Size / Price	Qty
BT-015-GMP-010

Lyophilized

Catalog #	Availability	Size / Price	Qty
BT-015-GMP-025
BT-015-GMP-01M

Liquid

Catalog #	Availability	Size / Price	Qty
BT-015-GMP-025/LQ

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Recombinant Human IL-15 Protein GMP Bioactivity.

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Recombinant Human IL-15 GMP Protein, CF Summary

Single use vials supplement 1L of T Cell Media (Cat # CCM038-GMP) to support T Cell Cultures in a G-Rex 100M bioreactor
Liquid formulation minimizes reconstitution steps
Lot-to-lot consistency
Stringent guidelines for patient safety
Scalability necessary to support successful therapeutics
Learn more about manufacturing in our new GMP facility
Test it in your process! Request a sample of GMP IL-15

Product Specifications

Purity

>97%, by SDS-PAGE with quantitative densitometry by Coomassie® Blue Staining. The molecular weight by mass spectrometry is 12761 Da ± 5 Da

Endotoxin Level

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

Activity

Measured in a cell proliferation assay using MO7e human megakaryocytic leukemic cells. The ED₅₀ for this effect is 0.300-2.60 ng/mL. The specific activity of recombinant human IL-15 is >2.00 x 10⁸ units/mg, which is calibrated against the human IL-15 reference standard (NIBSC code: 95/554).

Source

E. coli-derived human IL-15 protein
Asn49-Ser162
Produced using non-animal reagents in an animal-free laboratory.
Manufactured and tested under cGMP guidelines.

Accession #

P40933.1

N-terminal Sequence
Analysis

Asn49-Trp-Val-Asn-Val-Ile-Ser-Asp-Leu-Lys

Predicted Molecular Mass

13 kDa

SDS-PAGE

9 kDa, under reducing conditions

Product Datasheets

BT-015-GMP (lyophilized)

Product Datasheet

COA

SDS

BT-015-GMP/LQ (liquid)

Product Datasheet

COA

SDS

BT-015-GMP

Formulation	Lyophilized from a 0.2 μm filtered solution in PBS with Trehalose.
Reconstitution	Reconstitute at 100-500 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.

BT-015-GMP/LQ

Formulation	Supplied as a 0.2 μm filtered solution in PBS.
Shipping	The product is shipped with dry ice or equivalent. 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 ≤ -65 °C as supplied. Refer to lot specific COA for the Use by Date. 1 month, 2 to 8 °C under sterile conditions after opening. 3 months, ≤ -20 °C under sterile conditions after opening.

Scientific Data

Bioactivity

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GMP-grade Recombinant Human IL-15 (Catalog # BT-015-GMP) stimulates cell proliferation in the MO7e human megakaryocytic leukemic cell line. The ED₅₀for this effect is 0.300-2.60 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.

SDS-PAGE

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2 μg/lane of GMP-grade Recombinant Human IL-15 (Catalog # BT-015-GMP) was resolved with SDS-PAGE under reducing (R) conditions and visualized by Coomassie® Blue staining, showing a single band at 9 kDa.

ELISA

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Two samples of GMP-grade human IL-15 (Catalog number BT-015-GMP, green circles) were interpolated with the human IL-15 Quantikine ELISA (D1500) standard curve (black circles) using 4PL regression analysis. The human IL-15 Quantikine ELISA has an assay range of 3.9-250 pg/mL.

ELISA

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Thirteen samples of GMP-grade human IL-15 (Catalog number BT-015-GMP, green circles) were interpolated with the Simple Plex Human IL-15 cartridge (SPCKB-PS-000500) standard curve (black circles) using 4PL logistic regression analysis. The Simple Plex IL-15 cartridge has an assay range of 0.2-1,950 pg/mL.

Data

Charge consistency of GMP Human IL-15 Protein

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Three independent lots of Recombinant Human IL-15 GMP Protein (Catalog # BT-015-GMP) were analyzed by Maurice icIEF using native fluorescence detection (Mkr 5.85 and 9.99 are pI Markers). Profiles from the three runs were superimposed, showing excellent manufacturing consistency.

Data

Purity consistency of GMP Human IL-15 Protein

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Three independent lots of Recombinant Human IL-15 GMP Protein (Catalog # BT-015-GMP) were analyzed by Maurice CE-SDS PLUS (IS is an Internal Standard). A gel-like representation of the purity analysis data (inset) can be obtained from the Lane View feature in Compass software for iCE. Profiles from the three runs were superimposed, showing excellent manufacturing consistency.

Data

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Donor PBMCs were grown using ExCellerate NK Cell Expansion Media (Catalog # CCM037) supplemented with IL-2 (Catalog # BT-002-GMP), IL-12 (Catalog # 10018-IL), IL-15 (Catalog # BT-015-GMP), IL-18 (Catalog # BT-018-GMP), and IL-21 (Catalog # BT-021-GMP) on plates coated with anti-human NKp46 (Catalog # MAB1850). PBMCs were plated to contain 1.8e4 NK cells as determined by flow cytometry on day 0. On day 5, 0.1e6 total cells were taken to seed a 6 well plate. Viability, expansion, and NK purity were analyzed on day 9, with n=5 +/- SEM. A: Total expansion of CD56+ CD3- cells between day 0 and day 9. B: PBMCs grown in ExCellerate NK Cell Expansion Media supplemented with cytokines exhibit viability greater than 80% at day 9.

Data

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Donor PBMCs were grown using ExCellerate NK Cell Expansion Media (Catalog # CCM037) supplemented with IL-2 (Catalog # BT-002-GMP), IL-12 (Catalog # 10018-IL), IL-15 (Catalog # BT-015-GMP), IL-18 (Catalog # BT-018-GMP), and IL-21 (Catalog # BT-021-GMP) on plates coated with anti-human NKp46 (Catalog # MAB1850). PBMCs were plated to contain 1.8e4 NK cells as determined by flow cytometry on day 0. On day 5, 0.1e6 total cells were taken to seed a 6 well plate. Viability, expansion, and NK purity were analyzed on day 9, with n=5 +/- SEM for day 9; n=1 for day 0. A: Purity of NK cells at day 9. B: NK ExCellerate media preferentially expands CD56+ NK cells. Percentage of CD56+ cells in culture rose from less than 10% in both donors to more than 60% by day 9.

Reconstitution Calculator

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 ( gamma c) 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 / gamma c 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).

Immunotherapy treatment with recombinant IL-15 has the advantage of not stimulating Treg cells like IL-2 does but has the drawback of associated toxicity at higher doses. This has led to increased investigation on mitigating IL-15 toxicity and combination immunotherapy approaches using immune checkpoint inhibitors (19, 20). Preclinical and early clinical studies have shown the potential of also using IL-15 in combination with cancer vaccines to improve their anti-tumor response (20).

IL-15 can also be used for the preconditioning of CAR T cells or for engineering cells to express IL-15 in vivo. Adoptive cell transfer of NK cells engineered to express CD19 and IL-15 were well tolerated in patients with CD19-positive cancers (20). IL-15 can be used in combination with other cytokines like IL-21 to increase the efficiency of NK cell expansion and maturation in stem cell culture protocols (21). The combination of IL-15 with IL-7 also promotes expansion of early-differentiated CD8+ T cells in culture with the added benefit of decreasing Treg cell generation, unlike IL-2, for adoptive cell transfer in cancer immunotherapy (22). GMP IL-7 and GMP IL-15 are commonly used in combination for ex vivo expansion of T cells for cellular therapies.

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.
Xue, D. et al. (2021) Antib Ther. 4:123.
Wolfarth, A.A. et al. (2022) Immune Netw. 22:e5.
Oberoi, P. et al. (2020) Cells. 9:811.
Chamucero-Millares, J.A. et al. (2021) Cellular Immunol. 360:104257.

Long Name

Interleukin 15

Entrez Gene IDs

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

Alternate Names

IL15; IL-15; IL-15MGC9721; interleukin 15; interleukin-15

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:

Designed, manufactured and tested under an ISO 9001:2015 and ISO 13485:2016 certified quality system
Documented and controlled manufacturing process
Control of documentation and process changes by QA
Personnel training programs
Raw material inspection and vendor qualification/monitoring program
Validated equipment, processes and test methods
Equipment calibration and maintenance schedules using a Regulatory Asset Manager
Facility/Utilities maintenance, contamination controls, safety and pest control programs
Material review process for variances
Robust product stability program following relevant ICH guidelines

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 application. Each product is provided with a lot-specific Certificate of Analysis that contains the product's specifications and test results. Quality control testing may include, but is not limited to:

N-terminal amino acid analysis
SDS-PAGE purity analysis
Molecular weight analysis via mass spectrometry
Endotoxin assessment per USP <85> and Ph. Eur. 2.6.14 guidelines
Bioassay analysis
Microbial testing per USP <71> and Ph. Eur. 2.6.1 guidelines
Host cell protein assessment
Host cell DNA assessment
Mycoplasma assessment

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 and St. Paul, 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