ProPak™ Recombinant Human IL-15 GMP Protein, CF GMP

Name: ProPak™ Recombinant Human IL-15 GMP Protein, CF
Brand: R&D Systems
SKU: PPK-015-GMP

R&D Systems, part of Bio-Techne | Catalog # PPK-015-GMP

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Product Datasheet / COA / SDS

Key Product Details

Closed-System Process In order to de-risk your therapy as much as possible, ProPak GMP cytokines are designed to integrate seamlessly into a closed-system process. The risk of contamination is significantly lowered as a result.
Weldable Tubing Each ProPak bag is outfitted with weldable tubing, so you can connect it directly to your media, then add both to your bioreactor of choice. Tubing is compatible with any bagged media for use in a 1 L bioreactor, such as the G-Rex.
Ready-to-Use Format Supplied in a frozen liquid format. Extensive quality testing guarantees that the liquid formulation is just as potent and stable as lyophilized equivalents, allowing you to safely take away the need for reconstitution steps.
Reduced Manual Touchpoints By removing both reconstituting and aliquoting steps, there is less hands-on technician time. This drastically reduces risks of error while streamlining your journey to the clinic.

Source:	E. coli
Accession #:	P40933.1
Applications:	Bioactivity

View Full Technical Details for ProPak™ Recombinant Human IL-15 GMP Protein, CF

Technical Data
Citations / Reviews

Product Specifications for ProPak™ Recombinant Human IL-15 GMP Protein, CF

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.
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	<5.0 EU/mL by the LAL method.
N-terminal sequence Analysis	Asn49-Trp-Val-Asn-Val-Ile-Ser-Asp-Leu-Lys
Predicted Molecular Mass	13 kDa
SDS-PAGE	13 kDa
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).

Scientific Data Examples for ProPak™ Recombinant Human IL-15 GMP Protein, CF

	Lot to Lot Consistency ProPak GMP-grade Recombinant Human IL-15 (PPK-015-GMP) stimulates cell proliferation in the MO7e human megakaryocytic leukemic cell line. The ED₅₀ for 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 ProPak GMP IL‑15
	ProPak cytokines are successfully recovered into 1L media bags ProPak IL-7 (PPK-007-GMP) and ProPak IL-15 (PPK-015-GMP) were added to Xeno-free Human T cell media in a bag (CCM038-GMP-1B). In parallel, liquid IL-7 (BT-007-GMP-025/LQ) and IL-15 (BT-015-GMP-025/LQ) or lyophilized IL-7 (BT-007-GMP) and IL-15 (BT-015-GMP) were added to Xeno-free Human T cell media in a bottle (CCM038-GMP-1L). After cytokine addition, the concentration of IL-7 (SPCKB-CS-003676) and IL-15 (SPCKB-CS-003688) was determined by the Ella automated immunoassay system. Data is the average of 4 independent experiments with error bars ±SD.
	ProPak cytokines support T cell growth ProPak IL-7 (PPK-007-GMP) and ProPak IL-15 (PPK-015-GMP) were compared liquid IL-7 (BT-007-GMP-025/LQ) and IL-15 (BT-015-GMP-025/LQ) or lyophilized IL-7 (BT-007-GMP) and IL-15 (BT-015-GMP). Each were added to Xeno-free Human T cell media in a bag (CCM038-GMP-1B) with 5% huAB Serum. T cells from 3 donors were activated and expanded in G-Rex bioreactors for 9 days and assessed for fold expansion. Data is the average of 4 independent experiments with 3 donors per experiment, error bars ±SD.

Formulation, Preparation and Storage

Carrier Free

What does CF mean?

CF stands for Carrier Free (CF). We typically add Bovine Serum Albumin (BSA) as a carrier protein to our recombinant proteins. Adding a carrier protein enhances protein stability, increases shelf-life, and allows the recombinant protein to be stored at a more dilute concentration. The carrier free version does not contain BSA.

What formulation is right for me?

In general, we advise purchasing the recombinant protein with BSA for use in cell or tissue culture, or as an ELISA standard. In contrast, the carrier free protein is recommended for applications, in which the presence of BSA could interfere.

PPK-015-GMP

Formulation	Supplied as a 0.2 μm filtered solution in PBS, recombinant HSA, and Trehalose.
Shipping	The product is shipped on dry ice. 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 6 months when stored between -14 °C and -40 °C. Can be stored up to 2 weeks at 2-8 °C. Refer to lot specific COA for the Use by Date.

Reconstitution Calculator

The reconstitution calculator allows you to quickly calculate the volume of a reagent to reconstitute your vial. Simply enter the mass of reagent and the target concentration and the calculator will determine the rest.

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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.

Item	Value
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	IL-15, IL-15MGC9721, IL15, interleukin 15, interleukin-15

Manufacturing Specifications

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, Mass Spectrometry, Host Cell Protein, Host Cell DNA, Mycoplasma testing performed on each bulk QC lot, not on individual finished product lots
Finished product testing includes bioassay (compliance with an established range), endotoxin level (as determined by LAL assay), and microbial testing according to USP <71>

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.

R&D Systems sells GMP grade products for preclinical or clinical ex vivo cell therapy applications. 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 ProPak™ 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
Not for in vivo use

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