Recombinant Human/Mouse/Rat Activin A GMP Protein, CF Summary
The specific activity of Recombinant Human/Mouse/Rat Activin A is approximately 1 IU/μg, which is calibrated against human Activin A WHO International Standard (NIBSC code: 91/626).
Manufactured and tested under cGMP guidelines.
24 kDa, non-reducing conditions
|Formulation||Lyophilized from a 0.2 μm filtered solution in Acetonitrile and TFA.|
|Reconstitution||Reconstitute at 100-500 μg/mL in sterile 4 mM HCl.|
|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/Mouse/Rat Activin A (Catalog # 338‑GMP) induces hemoglobin expression in K562 human chronic myelogenous leukemia cells in a dose-dependent manner. The ED50 for this effect is 0.2‑1.2 ng/mL.
1 μg/lane of GMP-grade Recombinant Human/
Mouse/Rat Activin A (Catalog # 338‑GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by silver staining, showing single bands at 14 kDa and 24 kDa, respectively.
Background: Activin A
Activin and Inhibin are members of the TGF-beta superfamily of cytokines and are involved in a wide range of biological processes including tissue morphogenesis and repair, fibrosis, inflammation, neural development, hematopoiesis, reproductive system function, and carcinogenesis (1‑7). Activin and Inhibin are produced as precursor proteins. Their amino terminal propeptides are proteolytically cleaved and facilitate formation of disulfide-linked dimers of the bioactive proteins (8, 9). Activins are nonglycosylated homodimers or heterodimers of various beta subunits ( beta A, beta B, beta C, and beta E in mammals), while Inhibins are heterodimers of a unique alpha subunit and one of the beta subunits. Activin A is a widely expressed homodimer of two beta A chains. The beta A subunit can also heterodimerize with a beta B or beta C subunit to form Activin AB and Activin AC, respectively (10). The 14 kDa mature human beta A chain shares 100% amino acid sequence identity with bovine, feline, mouse, porcine, and rat beta A. Activin A exerts its biological activities by binding to the type 2 serine/threonine kinase Activin RIIA which then noncovalently associates with the type 1 serine/threonine kinase Activin RIB/ALK-4 (7, 11). Signaling through this receptor complex leads to Smad activation and regulation of activin-responsive gene transcription (7, 11). The bioactivity of Activin A is regulated by a variety of mechanisms (11). BAMBI, Betaglycan, and Cripto are cell‑associated molecules that function as decoy receptors or limit the ability of Activin A to induce receptor complex assembly (12‑14). The intracellular formation of Activin A can be prevented by the incorporation of the beta A subunit into Activin AC or Inhibin A (3, 10). And the bioavailability of Activin A is restricted by its incorporation into inactive complexes with alpha 2-Macroglobulin, Follistatin, and FLRG (15, 16).
- Kumanov, P. et al. (2005) Reprod. Biomed. Online 10:786.
- Maeshima, A. et al. (2008) Endocr. J. 55:1.
- Rodgarkia-Dara, C. et al. (2006) Mutat. Res. 613:123.
- Werner, S. and C. Alzheimer (2006) Cytokine Growth Factor Rev. 17:157.
- Xu, P. and A.K. Hall (2006) Dev. Biol. 299:303.
- Shav-Tal, Y. and D. Zipori (2002) Stem Cells 20:493.
- Chen, Y.G. et al. (2006) Exp. Biol. Med. 231:534.
- Gray, A.M. and A.J. Mason (1990) Science 247:1328.
- Mason, A.J. et al. (1996) Mol. Endocrinol. 10:1055.
- Thompson, T.B. et al. (2004) Mol. Cell. Endocrinol. 225:9.
- Harrison, C.A. et al. (2005) Trends Endocrinol. Metab. 16:73.
- Onichtchouk, D. et al. (1999) Nature 401:480.
- Gray, P.C. et al. (2002) Mol. Cell. Endocrinol. 188:254.
- Kelber, J.A. et al. (2008) J. Biol. Chem. 283:4490.
- Phillips, D.J. et al. (1997) J. Endocrinol. 155:65.
- Schneyer, A. et al. (2003) Endocrinology 144:1671.
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
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 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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