Recombinant Human IL-7 GMP Protein, CF

Name: Recombinant Human IL-7 GMP Protein, CF
Brand: R&D Systems
SKU: BT-007-GMP
Price: 1025 USD

Catalog #: BT-007-GMP Datasheet / COA / SDS

New! Bypass reconstitution steps by using a liquid formulation of GMP-grade Recombinant Human IL-7. Find out more here.

Animal-Free

Single Use Lyophilized Vial

Catalog #	Availability	Size / Price	Qty
BT-007-GMP-010

Lyophilized

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

Liquid

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

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We are offering customers the opportunity to try a sample of animal-free GMP proteins. Request your sample of Recombinant Human IL-7 GMP Protein.

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Recombinant Human IL‑7 GMP Protein SEC-MALS.

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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. The molecular weight by mass spectrometry is 17507 Da ± 50 Da

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

COA

SDS

BT-007-GMP/LQ (liquid)

Product Datasheet

COA

SDS

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 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

SEC-MALS

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Recombinant Human IL-7 GMP (Catalog # BT-007-GMP) has a molecular weight (MW) of 18.4 kDa as analyzed by SEC-MALS, suggesting that this protein is a monomer.

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.

Surface Plasmon Resonance (SPR)

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Recombinant Human IL-7R alpha/CD127 Fc Chimera (306-IR) was captured on Biacore Sensor Chip CM5 via Recombinant Protein A/G/L (Catalog # NBP2-34985), and binding to Recombinant Human IL-7 GMP (Catalog # BT-007-GMP) was measured at a concentration range between 0.244 nM and 500 nM. The double-referenced sensorgram was fit to a 1:1 binding model to determine the binding kinetics and affinity, with an affinity constant of KD=62.6 nM. (Biacore T200).

Reconstitution Calculator

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:

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