>95%, by SDS-PAGE with silver staining, under reducing conditions.
<0.10 EU per 1 μg of the protein by the LAL method.
Measured by its ability to inhibit BMP-4-induced alkaline phosphatase production by ATDC5 mouse chondrogenic cells. The ED50 for this effect is 0.04‑0.2 μg/mL in the presence of 50 ng/mL of Recombinant Human BMP‑4 (Catalog # 314-BP).
Mouse myeloma cell line, NS0-derived human Noggin protein Gln28-Cys232 Manufactured and tested under current Good Manufacturing Practice (GMP) guidelines.
GMP-grade Recombinant Human Noggin (Catalog # 6057-GMP) inhibits BMP-4-induced alkaline phosphatase production in the ATDC5 mouse chondrogenic cell line. The ED50 for this effect is 0.04‑0.2 µg/mL in the presence of 50 ng/mL of Recombinant Human BMP‑4 (Catalog # 314‑BP).
1 μg/lane of GMP-grade Recombinant Human Noggin (Catalog # 6057-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by silver staining, showing bands at 31 kDa and 57 kDa, respectively.
Noggin is a secreted homodimeric glycoprotein that is an antagonist of bone morphogenetic proteins (BMPs) (1, 2). Human Noggin cDNA encodes a 232 amino acid (aa) precursor protein; cleavage of a 19 aa signal peptide generates the 213 aa mature protein which contains an N-terminal acidic region, a central basic heparin‑binding segment and a C-terminal cysteine-knot structure (2). Secreted Noggin probably remains close to the cell surface due to its binding of heparin‑containing proteoglycans (3). Noggin is very highly conserved among vertebrates, such that mature human Noggin shares 99%, 99%, 98%, 97% and 89% aa sequence identity with mouse, rat, bovine, equine and chicken Noggin, respectively. Noggin binds some BMPs such as BMP-4 with high affinity and others such as BMP-7 with lower affinity. It antagonizes BMP bioactivities by blocking epitopes on BMPs that are needed for binding to both type I and type II receptors (2, 4). During embryogenesis, Noggin antagonizes specific BMPs at defined times, for example, during neural tube, somite and cardiomyocyte growth and patterning (5-7). During skeletal development, Noggin prevents chondrocyte hyperplasia, thus allowing proper formation of joints (4). Mutations within the cysteine-knot region of human Noggin are linked to multiple types of skeletal dysplasias that result in apical joint fusions (8). Noggin is expressed in defined areas of the adult central nervous system and peripheral tissues such as lung, skeletal muscle and skin (1). During culture of human embryonic stem cells (hESC) or neural stem cells under certain conditions, addition of Noggin to antagonize BMP activity may allow stem cells to proliferate while maintaining their undifferentiated state, or alternatively, to differentiate into dopaminergic neurons (6, 9 - 13). Noggin also appears to maintain adult stem cell populations in-vivo, for example, maintaining neural stem cells within the hippocampus (13).
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Itsykson, P. et al. (2005) Mol. Cell. Neurosci. 30:24.
Yuasa, S. et al. (2005) Nat. Biotechnol. 23:607.
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Xu, R.-H. et al. (2005) Nat. Methods 2:185.
Wang, G. et al. (2005) Biochem. Biophys. Res. Commun. 330:934.
Chaturvedi, G. et al. (2009) Cell Prolif. 42:425.
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Bonaguidi, M.A. et al. (2008) J. Neurosci. 28:9194.
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 9001:2008 and ISO 13485:2003 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)
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.
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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