Recombinant Human TNF-alpha GMP Protein, CF

Animal-Free
    
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  • Purity
    >97%, by SDS-PAGE with silver staining.
  • Endotoxin Level
    <0.10 EU per 1 μg of the protein by the LAL method.
  • Activity
    Measured in a cytotoxicity assay using L‑929 mouse fibroblast cells in the presence of the metabolic inhibitor actinomycin D. Matthews, N. and M.L. Neale (1987) in Lymphokines and Interferons, A Practical Approach. Clemens, M.J. et al. (eds): IRL Press. 221. The ED50 for this effect is 25-100 pg/mL.
    The specific activity of recombinant human TNF-alpha GMP is approximately 7.6 x 104 IU/μg, which is calibrated against human TNF-alpha WHO International Standard (NIBSC code: 88/786).
  • Source
    E. coli-derived human TNF-alpha protein
    Val77-Leu233, with and without an N-terminal Met
    Produced using non-animal reagents in an animal-free laboratory.
    Manufactured and tested under cGMP guidelines.
  • Accession #
  • N-terminal Sequence
    Analysis
    Met-Val77-Arg-Ser-Ser-Ser-Arg-Thr-Pro-Ser
    Val77-Arg-Ser-Ser-Ser-Arg-Thr-Pro-Ser-Asp
  • Predicted Molecular Mass
    17 kDa
  • SDS-PAGE
    17 kDa, reducing conditions
Product Datasheets

Certificate of Analysis Lookup

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210-GMP
 
Formulation Lyophilized from a 0.2 μm filtered solution in PBS.
 
Reconstitution Reconstitute at 100-200 μg/mL in PBS.
 
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.
  • A minimum of 6 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.
 
Data Images

GMP-grade Recombinant Human TNF-alpha (Catalog # 210-GMP) induces cytotoxicity in the L-929 mouse fibroblast cell line in the presence of the metabolic inhibitor actinomycin D. The ED50 is
25-100 pg/mL.

1 μg/lane of GMP-grade Recombinant Human TNF-alpha (Catalog # 210-GMP) was resolved by SDS-PAGE with silver staining, under reducing (R) conditions, showing a single band at 17 kDa.

MALDI-TOF analysis of GMP-grade Recombinant Human TNF-alpha (Catalog # 210‑GMP). The major peak at 17348 corresponds to the calculated molecular mass without an N-terminal Met, 17353 Da. The minor peak at 17480 corresponds to the calculated molecular mass with an N-terminal Met, 17484 Da. The peak at 17565 is a matrix-associated artifact of the MALDI-TOF.
Background: TNF-alpha
Tumor necrosis factor alpha (TNF-alpha ), also known as cachectin and TNFSF2, is the prototypic ligand of the TNF superfamily. It is a pleiotropic molecule that plays a central role in inflammation, immune system development, apoptosis, and lipid metabolism (1, 2). Human TNF-alpha consisits of a 35 amino acid (aa) cytoplasmic domain, a 21 aa transmembrane segment, and a 177 aa extracellular domain (ECD) (3). Within the ECD, human TNF-alpha shares 97% aa sequence identity with rhesus and 71%-92% with bovine, canine, cotton rat, equine, feline, mouse, porcine, and rat TNF-alpha. TNF-alpha is produced by a wide variety of immune, epithelial, endothelial, and tumor cells (1, 2). TNF-alpha is assembled intracellularly to form a noncovalently linked homotrimer which is expressed on the cell surface (4). Cell surface TNF-alpha can induce the lysis of neighboring tumor cells and virus infected cells, and it can generate its own downstream cell signaling following ligation by soluble TNFR I (2, 5). Shedding of membrane bound TNF-alpha by TACE/ADAM17 releases the bioactive cytokine, a 55 kDa soluble trimer of the TNF-alpha extracellular domain (6-8). TNF-alpha binds the ubiquitous 55-60 kDa TNF RI (9, 10) and the hematopoietic cell-restricted 80 kDa TNF RII (11, 12), both of which are also expressed as homotrimers (1, 2, 13). Both type I and type II receptors bind TNF-alpha with comparable affinity (14), although only TNF RI contains a cytoplasmic death domain which triggers the activation of apoptosis. Soluble forms of both types of receptors are released and can neutralize the biological activity of TNF-alpha (15).
  • References:
    1. Zelova, H. and J. Hosek (2013) Inflamm. Res. 62:641.
    2. Juhasz, K. et al. (2013) Expert Rev. Clin. Immunol. 9:335.
    3. Pennica, D. et al. (1984) Nature 312:724.
    4. Tang, P. et al. (1996) Biochemistry 35:8216.
    5. Perez, C. et al. (1990) Cell 63:251.
    6. Black, R.A. et al. (1997) Nature 385:729.
    7. Moss, M.L. et al. (1997) Nature 385:733.
    8. Gearing, A.J.H. et al. (1994) Nature 370:555.
    9. Schall, T.J. et al. (1990) Cell 61:361.
    10. Loetscher, H. et al. (1990) Cell 61:351.
    11. Dembic, Z. et al. (1990) Cytokine 2:231.
    12. Smith, C.A. et al. (1990) Science 248:1019.
    13. Loetscher, H. et al. (1991) J. Biol. Chem. 266:18324.
    14. Pinckard, J.K. et al. (1997) J. Biol. Chem. 272:10784.
    15. Engelmann, H. et al. (1990) J. Biol. Chem. 265:1531.
  • Long Name:
    Tumor Necrosis Factor alpha
  • Entrez Gene IDs:
    7124 (Human); 21926 (Mouse); 24835 (Rat); 397086 (Porcine); 280943 (Bovine); 403922 (Canine); 100033834 (Equine); 493755 (Feline); 100009088 (Rabbit)
  • Alternate Names:
    APC1 protein; Cachectin; Cachetin; DIF; TNF; TNF, monocyte-derived; tnfa; tnf-a; TNFalpha; TNF-alpha; TNF-alphacachectin; TNFATNF, macrophage-derived; TNFSF1A; TNFSF2; TNFSF2TNF superfamily, member 2; tumor necrosis factor (TNF superfamily, member 2); tumor necrosis factor alpha; Tumor necrosis factor ligand superfamily member 2; tumor necrosis factor; tumor necrosis factor-alpha
Manufacturing Specifications
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.


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.
  • For ex vivo research or bioproduction, additional documentation can be provided.

   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.

We suggest you print and retain a copy of these End User Terms of Use of Product for your records.

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.

R&D Systems, Inc. has the right, at its sole discretion, to modify, add or remove any terms or conditions of these End User Terms of Use without notice or liability to you. Any changes to these End User Terms of Use are effective immediately following the printing of such changes on this product insert. The most recent version of these End User Terms of Use of Product may be found at: RnDSystems.com/Legal.

You agree to review these End User Terms of Use of Product to ensure any subsequent use by you of R&D Systems' GMP Products following changes to these End User Terms of Use of Product constitutes your acceptance of all such changes.

 

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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