Recombinant Human NRG1-beta 1/HRG1-beta 1 EGF Domain GMP, CF

(1 Review)
  
  • Purity
    >97%, by SDS-PAGE with silver staining, under reducing conditions.
  • Endotoxin Level
    <0.01 EU per 1 μg of the protein by the LAL method.
  • Activity
    Measured in a serum-free cell proliferation assay using MCF‑7 human breast cancer cells. Karey, K.P. et al. (1988) Cancer Research 48:4083. The ED50 for this effect is 0.06-0.3 ng/mL.
  • Source
    E. coli-derived Thr176-Lys246 Manufactured and tested under cGMP guidelines.
  • Accession #
  • N-terminal Sequence
    Analysis
    Thr-Ser-His-Leu-Val-Lys-(Cys)-Ala-Glu-Lys
  • Predicted Molecular Mass
    8 kDa
  • SDS-PAGE
    8 kDa, reducing conditions
396-GMP
 
Formulation Lyophilized from a 0.2 μm filtered solution in Acetonitrile and TFA.
Reconstitution Reconstitute at 100 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 NRG1‑ beta 1/HRG1-beta 1 (Catalog # 396-GMP) stimulates cell proliferation of the MCF-7 human breast cancer cell line. The ED50 for this effect is 0.06-0.3 ng/mL.
1 μg/lane of Recombinant Human GMP-grade NRG1-beta 1/HRG1-beta 1 (Catalog # 396‑GMP) was resolved with SDS-PAGE under reducing (R) conditions and visualized by silver staining, showing a single band at 8 kDa.

Mass Spectrometry
MALDI-TOF analysis of GMP-grade Recombinant Human NRG-beta 1/HRG-beta 1 (Catalog # 396-GMP). The major peak corresponds to the calculated molecular mass, 8241 Da. The minor peak at 8455 Da is a matrix-associated artifact of the MALDI‑TOF.
Background: Neuregulin-1 beta 1/NRG1 beta 1

The neuregulin family of structurally related glycoproteins comprises products from four distinct but related genes, Nrg-1, Nrg-2, Nrg-3, and Nrg-4. Through alternative splicing or the use of alternative promoters, Nrg-1 has been shown to encode more than 14 soluble or transmembrane proteins. The extracellular domain of the transmembrane NRG1 isoforms can be proteolytically cleaved to release soluble growth factors. All NRG1 isoforms contain an EGF-like domain ( alpha - or beta -splice variant that differ in their C-terminal region) that is required for their direct binding to the ErbB3 or ErbB4 receptor tyrosine kinases. The ErbB3 or ErbB4 subsequently recruits and heterodimerizes with ErbB2, resulting in tyrosine phosphorylation and NRG1 signaling. NRG1 isoforms can be classified into three major subtypes. Type I (Neu Differentiation Factor, NDF; Heregulin, HRG; Acetylcholine Receptor Inducing Activity, ARIA) and type II (Glial Growth Factor, GGF) NRG1s have an immunoglobulin (Ig)-like domain N-terminal to the EGF-like domain. Type I NRG1s differ from type II NRG1s by having a glycosylation-rich domain between the Ig-like and the EGF-like domains. Type III NRG1s (Sensory and Motor neuron-Derived Factor) lacks the Ig-like domain but has a cysteine rich domain (CRD) instead. NRG1 isoforms show distinct spatial and temporal expression patterns. These proteins play important roles during development of both the nervous system and the heart. They have been shown to regulate the selective expression of neurotransmitter receptors in neurons and at the neuromuscular junction, and promote the differentiation and development of Schwann cells from neural crest stem cells. NRG1s have also been shown to be involved in the establishment of the oligodendroglial lineage.

  • References:
    1. Buonanno, A., and Fischbach, G.D. (2001) Curr. Opin. Neurobiol. 11:287.
    2. Adlkofer, K. and Lai, C. (2000) Glia 29:104.
    3. Garratt, A.N. et al. (2000) BioEssays 22:987.
  • Entrez Gene IDs:
    3084 (Human); 211323 (Mouse); 112400 (Rat)
  • Alternate Names:
    Neuregulin1 beta 1; Neuregulin-1 beta 1

GMP Proteins
R&D Systems' 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 sterility 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.

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.

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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-Information

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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.

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We have 1 review tested in 1 application: Electrophysiology.
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  Very Good
 Electrophysiology Anonymous 12/11/2017
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Summary

ApplicationElectrophysiology
Reason for RatingNRG1 performed as expected based on previously published data.

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