Recombinant Human IL-7 GMP Protein, CF

Catalog #: BT-007-GMP Datasheet

Animal-Free

Catalog #	Availability	Size / Price	Qty
BT-007-GMP-025
BT-007-GMP-01M

Recombinant Human IL-7 GMP Protein Bioactivity

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All IL-7 Proteins and Enzymes

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Recombinant Human IL-7 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-7

Product Specifications

Purity

>97%, by SDS-PAGE with quantitative densitometry by Coomassie® Blue Staining.

Endotoxin Level

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

Activity

Measured in a cell proliferation assay using PHA-activated human peripheral blood lymphocytes (PBL). Yokota, T. et al. (1986) Proc. Natl. Acad. Sci. USA 83:5894. The ED₅₀ for this effect is 0.100-0.500 ng/mL.The specific activity of Recombinant Human IL-7 is >1.00 x 10⁸ units/mg, which is calibrated against the human IL-7 reference standard (NIBSC code: 90/530).

Source

E. coli-derived human IL-7 protein
Asp26-His177, with an N-terminal Met
Produced using non-animal reagents in an animal-free laboratory.
Manufactured and tested under cGMP guidelines.

Accession #

P13232.1

N-terminal Sequence
Analysis

Met-Asp26-(Cys)-Asp-Ile-Glu-Gly-Lys-Asp-Gly

Predicted Molecular Mass

17 kDa

SDS-PAGE

17 kDa, under reducing conditions

Product Datasheets

BT-007-GMP (lyophilized)

Product Datasheet

BT-007-GMP/LQ (liquid)

Product Datasheet

BT-007-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-007-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 6 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-7 (Catalog # BT-007-GMP) stimulates proliferation of PHA-activated human peripheral blood lymphocytes. The ED₅₀ for this effect is 0.100-0.500 ng/mL. Three independent lots were tested for activity and plotted on the same graph to show lot-to-lot consistency of GMP IL-7.

SDS-PAGE

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2 μg/lane of GMP-grade Recombinant Human IL-7 Protein (Catalog # BT-007-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by Coomassie® Blue staining, showing a single band at 17 kDa.

Mass Spectrometry

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Analysis of GMP-grade Recombinant Human IL-7 (Catalog # BT-007-GMP), showing a major peak at 17501 Da.

ELISA

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Four samples of GMP-grade human IL-7 (Catalog number BT-007-GMP, green circles) were interpolated with the human IL-7 Quantikine High Sensitivity ELISA Kit (HS750) standard curve (black circles) using 4PL logistic regression analysis. The IL-7 Quantikine High Sensitivity ELISA Kit has an assay range of 0.156-10 pg/mL for cell culture supernates and 0.25-16 pg/mL for serum, EDTA plasma and citrate plasma.

ELISA

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Thirteen samples of GMP-grade human IL-7 (Catalog number BT-007-GMP, green circles) were interpolated with the Simple Plex Human IL-7 cartridge (SPCKB-PS-000506) standard curve (black circles) using 4PL logistic regression analysis. The Simple Plex IL-7 cartridge has an assay range of 0.57-2,170 pg/mL.

Data

Purity consistency of GMP Human IL-7 Protein

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Three independent lots of Recombinant Human IL-7 GMP Protein (Catalog # BT-007-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

Charge consistency of GMP Human IL-7 Protein

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Three independent lots of Recombinant Human IL-7 GMP Protein (Catalog # BT-007-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.

Background: IL-7

IL-7 (interleukin-7) is a 25 kDa cytokine of the hemopoietin family that plays important roles in lymphocyte differentiation, proliferation, and survival (1-4). Human IL‑7 cDNA encodes 177 amino acids (aa) that include a 25 aa signal peptide (3). Human IL-7 shares approximately 60-63% aa sequence identity with mouse, rat, canine and feline IL-7, and 72-76% with equine, bovine, ovine, and porcine IL-7. Human and mouse IL-7 exhibit cross-species activity (2, 3).

IL-7 is produced by a wide variety of cells in primary and secondary lymphoid tissues, including stromal epithelial cells of the thymus, bone marrow, and intestines (1, 2, 5). Circulating IL-7 is limiting in healthy animals, but increases during lymphopenia (1, 6). IL-7 signals through a complex of the IL-7 Receptor alpha subunit (IL-7 R alpha, also known as CD127) with the common gamma chain ( gamma c) (1). The gamma c is also a subunit of the receptors for IL-2, -4, -9, -15, and -21 (1).

IL-7 R alpha is expressed on double negative (CD4-CD8-) and single positive (CD4+ or CD8+) naïve and memory T cells, but undergoes IL-7-mediated down‑regulation and shedding during antigen-driven T cell proliferation, and is absent on regulatory T cells (1, 2, 6-11). IL-7 contributes to the maintenance of all naïve and memory T cells, mainly by promoting expression of the anti-apoptotic protein Bcl-2 (9-11). It is required for optimal T cell-dendritic cell interaction (6). IL-7 is expressed early in B cell development prior to the appearance of surface IgM (1, 5, 9). In mouse, IL-7 activation of IL-7 R alpha is critical for both T cell and B cell lineage development, while in humans, it is required for T cell but not for B cell development (4, 9, 12, 13). However, IL-7 functions in both mouse and human pro-B cells to suppress premature Ig light chain recombination during proliferative growth (14, 15).

Like other common gamma-chain cytokines like IL-2 and IL-15, IL-7 and its receptor, IL-7R, has been used in a variety of immunotherapy applications, often in fluid tumors and in some instances of solid tumor models (16). Sometimes use of recombinant IL-7 is preferential as current studies and early clinical trials of cancer have found less severe toxicity or side effects upon treatment with IL-7 in comparison to IL-15 or IL-2 (16).

In CAR-T cell therapies, enhanced expression and secretion of human IL-7 and CCL19 have enhanced the ability of T cells to expand and migrate in vitro (17). Engineered CAR T cells expressing IL-7 or a constitutively active IL-7R results in increased efficacy of CAR T anti-tumor effects (16, 18). IL-7 is also frequently used in combination with IL-15 as a supplement in cell culture of CAR T cells to support their expansion (19). Additionally, IL-7/IL-15 in the presence of cord blood-derived T cells helps to maintain their early differentiation state (20). Monoclonal antibodies against IL-7R or small molecule inhibitors against the IL-7R signaling pathway are commonly used in circumstances of autoimmune diseases to delay disease progression (16). Also due to its ability to stimulate both adaptive and innate immune cells, treatment with IL-7 has shown improved survival in patients with sepsis who are at risk of deadly secondary infections (21), providing evidence for IL-7 applications beyond cancer immunotherapy.

References

Sasson, S.C. et al. (2006) Curr. Drug Targets 7:1571.
Barata, J.T. et al. (2006) Exp. Hematol. 34:1133.
Goodwin, R.G. et al. (1990) Proc. Natl. Acad. Sci. USA 86:302.
Namen, A.E. et al. (1988) Nature 333:571.
Shalapour, S. et al. (2012) PLoS ONE 7: e31939.
Saini, M. et al. (2009) Blood 113:5793.
Park, J.H. et al. (2004) Immunity 21:289.
Vranjkovic, A. et al. (2007) Int. Immunol. 19:1329.
Sudo, T. et al. (1993) Proc. Natl. Acad. Sci. 90:9125.
Seddon, B. et al. (2003) Nat. Immunol. 4:680.
Schluns, K.S. et al. (2000) Nat. Immunol. 5:426.
Peschon, J.J. et al. (1994) J. Exp. Med. 180:1955.
Pribyl, J.A. and T.W. LeBien (1996) Proc. Natl. Acad. Sci. 93:10348.
Johnson, K. et al. (2012) J. Immunol. 188:6084.
Nodland, S.E. et al. (2011) Blood 118:2116.
Wang, C. et al. (2022) Int. J. Mol. Sci. 23:10370.
Pang, N. et al. (2021) J Hematol Oncol. 14:118.
Li, L. et al. (2022) Sci Rep. 12:12506.
Xu, Y. et al. (2014) Blood. 123:3750.
Marton,C. et al. (2022) Cancer Gene Ther. 29:961.
Winer, H. et al. (2022) Cytokine. 160:156049.

Long Name

Interleukin 7

Entrez Gene IDs

3574 (Human); 16196 (Mouse); 25647 (Rat)

Alternate Names

IL7; IL-7; IL-7interleukin-7; interleukin 7; Lymphopoietin-1; PBGF

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 <71>
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.

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

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.

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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.

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TERMS AND CONDITIONS

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