Recombinant Human IFN-gamma GMP Protein, CF Summary
The specific activity of recombinant human IFN-gamma is approximately 2 x 104 IU/μg, which is calibrated against human IFN-gamma Standard (NIBSC code: 87/586).
Gln24-Gln166, with an N-terminal Met
Produced using non-animal reagents in an animal-free laboratory. Manufactured and tested under cGMP guidelines.
|Formulation||Lyophilized from a 0.2 μm filtered solution in Sodium Succinate, Mannitol and Tween® 80.|
|Reconstitution||Reconstitute at 200 μg/mL in sterile, deionized water.|
|Shipping||The product is shipped at ambient temperature. Upon receipt, store it immediately at the temperature recommended below.|
|Stability & Storage:||Use a manual defrost freezer and avoid repeated freeze-thaw cycles.
GMP-grade Recombinant Human IFN-gamma (Catalog # 285-GMP) demonstrates anti-viral activity in HeLa human cervical epithelial carcinoma cells infected with encephalomyocarditis (EMC) virus. The ED50 for this effect is 0.15-0.75 ng/mL.
1 μg/lane of GMP-grade Recombinant Human IFN-gamma (Catalog # 285-GMP) was resolved with SDS-PAGE under reducing (R) conditions and visualized by silver staining, showing a single band at 17 kDa.
MALDI-TOF analysis of GMP-grade Recombinant Human IFN-gamma (Catalog #
285-GMP). The major peak corresponds to the calculated molecular mass, 16881 Da. The minor peak at 17099 Da is a matrix-associated artifact of the MALDI-TOF.
Interferon-gamma (IFN-gamma ), also known as type II or immune interferon, exerts a wide range of immunoregulatory activities and is considered to be the prototype proinflammatory cytokine (1, 2). Mature human IFN-gamma exists as a non-covalently linked homodimer of 20-25 kDa variably glycosylated subunits (3). It shares 90% amino acid (aa) sequence identity with rhesus IFN-gamma, 59%‑64% with bovine, canine, equine, feline, and porcine IFN‑ gamma, and 37%‑43% with cotton rat, mouse, and rat IFN-gamma. IFN-gamma dimers bind to IFN-gamma RI ( alpha subunits) which then interact with IFN-gamma RII ( beta subunits) to form the functional receptor complex of two alpha and two beta subunits. Inclusion of IFN-gamma RII increases the binding affinity for ligand and the efficiency of signal transduction (4, 5). IFN-gamma is produced by a variety of immune cells under inflammatory conditions, notably by T cells and NK cells (6). It plays a key role in host defense by promoting the development and activation of Th1 cells, chemoattraction and activation of monocytes and macrophages, up‑regulation of antigen presentation molecules, and immunoglobulin class switching in B cells. It also exhibits antiviral, antiproliferative, and apoptotic effects (6, 7). In addition, IFN-gamma functions as an anti-inflammatory mediator by promoting the development of regulatory T cells and inhibiting Th17 cell differentiation (8, 9). The pleiotropic effects of IFN-gamma contribute to the development of multiple aspects of atherosclerosis (7).
- Billiau, A. and P. Matthys (2009) Cytokine Growth Factor Rev. 20:97.
- Pestka, S. et al. (2004) Immunol. Rev. 202:8.
- Gray, P.W. and D.V. Goeddel (1982) Nature 298:859.
- Marsters, S.A. et al. (1995) Proc. Natl. Acad. Sci. 92:5401.
- Krause, C.D. et al. (2000) J. Biol. Chem. 275:22995.
- Schroder, K. et al. (2004) J. Leukoc. Biol. 75:163.
- McLaren, J.E. and D.P. Ramji (2009) Cytokine Growth Factor Rev. 20:125.
- Muhl, H. and J. Pfeilschifter (2003) Int. Immunopharmacol. 3:1247.
- Kelchtermans, H. et al. (2008) Trends Immunol. 29:479.
Manufacturing SpecificationsGMP 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
- 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
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 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.
- 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.
Product Specific Notices
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.
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.
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