1 μg/lane of GMP-grade Recombinant Human IL-17E/IL-25 (Catalog # 1258-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by silver staining, showing bands at 17 kDa and 31 kDa, respectively.
MALDI-TOF analysis of GMP-grade Recombinant Human IL-17E (Catalog # 1258-GMP). The major peak at 33738 corresponds to the measured molecular weight of the intact dimeric protein. The calculated mass for a monomer is 16873 Da.
The Interleukin‑17 (IL‑17) family of proteins are immunoregulatory cytokines that share a conserved cysteine‑rich region. IL‑17E, which is also known as IL‑25, promotes Th2‑biased immune responses. This is in contrast to other IL‑17 family members which promote Th1- and Th17‑biased inflammation. IL‑25 is an important mediator of allergic reactions and protection against intestinal parasites (1, 2). Mature human IL‑25 shares 80% amino acid sequence identity with mouse and rat IL‑25 (3, 4). During helminth infections and allergic reactions, IL‑25 is locally up‑regulated in intestinal and airway epithelial cells, atopic dermatitis skin lesions, and local Th2 cells, eosinophils, and basophils (4‑9). It binds to IL‑17 RB but also requires IL‑17 RA to exert its activity (3, 8, 10). IL‑25 acts on a variety of cell types which respond with increased production of Th2 cytokines (e.g. IL‑4, IL‑5, IL‑13) and reduced production of Th1 and Th17 cytokines (e.g. IFN‑ gamma, IL‑12, IL‑23, IL‑17A, IL‑17F) (4‑6, 8, 9, 11‑15). Airway IL‑25 can be activated by MMP‑7, a protease that is up‑regulated in airway epithelium in response to allergen exposure (16). Cleaved IL‑25 shows enhanced binding to IL‑17 RB and stronger induction of Th2 cytokines (16). The Th2 cytokines, in turn, trigger expansion of Th2 memory cells and anti‑inflammatory M2 macrophages, increased eosinophil mobilization and activation, and dendritic cell migration (4, 6, 9, 13). These actions promote protective anti‑helminth immune responses (4, 5) as well as allergic inflammation and airway hyperreactivity (11). The IL‑25 induced suppression of Th1 and Th17 cytokines limits Th17 cell expansion and disease pathology in autoimmunity and colitis (12, 15). IL‑25 also promotes vascular endothelial cell proliferation and assembly into tubular structures (7). It supports the integrity of the blood‑brain barrier and limits CD4+ T cell infiltration into the brain (17).
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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.
Product Specific Notices
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.
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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.
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