>97%, by SDS-PAGE with silver staining, under reducing conditions.
<0.10 EU per 1 μg of the protein by the LAL method.
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 0.1-0.5 ng/mL.
The specific activity of Recombinant Human IL-7 is approximately 4.4 x 105 units/μg, which is calibrated against human IL-7 WHO Standard (NIBSC code: 90/530).
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.
MALDI-TOF analysis of GMP-grade Recombinant Human IL-7 (Catalog # 207‑GMP). The major peak corresponds to the calculated molecular mass, 17518 Da. The minor peak at 17711 Da is a matrix-associated artifact of the MALDI-TOF.
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, porcine, feline and canine 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 CD4+ or CD8+ single positive 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).
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.
GMP Proteins R&D Systems, a Bio-Techne Brand's GMP proteins are produced according to relevant sections of the following documents: WHO TRS, No. 822, 1992 Annex 1, Good Manufacturing Practices for Biological Products; USP Chapter 1043, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and USP Chapter 92, Growth Factors and Cytokines Used in Cell Therapy Manufacturing.
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 bioburden testing (using broth culture, Sabourand's dextrose and blood agar plates with results reported at 3 days and at 7 days)
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. Testing may include, but is not limited to, USP< 61> bioburden testing, positive identity testing, testing for adventitious agents and testing for residual host cell content.
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 its GMP grade recombinant protein products for research use or further manufacturing use in ex vivo cell therapy applications. They are not for in vivo use or for use as therapeutic or other drugs, biologic products or devices. 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.
All molecular biology procedures use animal-free media and dedicated labware.
Dedicated fermentors are utilized in committed animal-free areas.
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.
Low Endotoxin Level.
No impairment of biological activity.
High quality product obtained under stringent conditions.
The End User is aware that R&D Systems, Inc. sells its GMP products for research use only or further manufacturing and not for in vivo use, the production of therapeutics or other drugs or for biologic products or devices. 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.
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.
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