Recombinant Human NRG1-beta 1/HRG1-beta 1 EGF Domain GMP, CF Summary
Manufactured and tested under cGMP guidelines.
CF stands for Carrier Free (CF). We typically add Bovine Serum Albumin (BSA) as a carrier protein to our recombinant proteins. Adding a carrier protein enhances protein stability, increases shelf-life, and allows the recombinant protein to be stored at a more dilute concentration. The carrier free version does not contain BSA.
In general, we advise purchasing the recombinant protein with BSA for use in cell or tissue culture, or as an ELISA standard. In contrast, the carrier free protein is recommended for applications, in which the presence of BSA could interfere.
|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.
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.
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.
- Buonanno, A., and Fischbach, G.D. (2001) Curr. Opin. Neurobiol. 11:287.
- Adlkofer, K. and Lai, C. (2000) Glia 29:104.
- Garratt, A.N. et al. (2000) BioEssays 22:987.
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
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 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.
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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Reviews for Recombinant Human NRG1-beta 1/HRG1-beta 1 EGF Domain GMP, CF
Average Rating: 4 (Based on 1 Review)
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Reason for Rating: NRG1 performed as expected based on previously published data.