>97%, by SDS-PAGE with silver staining, under reducing conditions.
<0.10 EU per 1 μg of the protein by the LAL method.
Measured in a cell proliferation assay using BaF mouse pro-B cells transfected with TrkB. The ED50 for this effect is 0.2-2 ng/mL.
The specific activity of Recombinant Human/Mouse/Rat/Canine/Equine BDNF is approximately 1.3 x 103 units/μg, which is calibrated against recombinant human BDNF WHO Standard (NIBSC code: 96/534). Measured by its binding ability in a functional ELISA. When Recombinant Human TrkB Fc Chimera (Catalog # 688-TK) is coated at 1 μg/mL, recombinant human BDNF binds with an apparent Kd <1 nM.
Spodoptera frugiperda, Sf 21 (baculovirus)-derived BDNF protein His129-Arg247 Manufactured and tested under cGMP guidelines.
1 μg/lane of GMP-grade Recombinant Human/Mouse/Rat/Canine/Equine BDNF (Catalog # 248-GMP) was resolved with SDS-PAGE under reducing (R) conditions and visualized by silver staining, showing a band at 14 kDa.
Brain-derived neurotrophic factor (BDNF) is a member of the NGF family of neurotrophic factors (also named neurotrophins) that are required for the differentiation and survival of specific neuronal subpopulations in both the central as well as the peripheral nervous system. The neurotrophin family is comprised of at least four proteins including NGF, BDNF, NT-3, and NT-4/5. These secreted cytokines are synthesized as prepropeptides that are proteolytically processed to generate the mature proteins (1, 2). All neurotrophins have six conserved cysteine residues that are involved in the formation of three disulfide bonds and all share approximately 55% sequence identity at the amino acid level. Similarly to NGF, bioactive BDNF is predicted to be a non-covalently linked homodimer.
BDNF cDNA encodes a 247 amino acid residue precursor protein with a signal peptide and a proprotein that are cleaved to yield the 119 amino acid residue mature BDNF. The amino acid sequence of mature BDNF is identical in all mammals examined. High levels of expression of BDNF have been detected in the hippocampus, cerebellum, fetal eye and placenta. In addition, low levels of BDNF expression are also found in the pituitary gland, spinal cord, heart, lung and skeletal muscle. BDNF binds with high affinity and specifically activates the TrkB tyrosine kinase receptor (3).
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)
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.
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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