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Recombinant Human BMP-2 GMP Protein, CF GMP

Bio-Techne includes R&D Systems | Catalog # 355-GMP

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355-GMP-010
355-GMP-050

Key Product Details

Source

CHO

Accession #

Structure / Form

Disulfide-linked homodimer

Conjugate

Unconjugated

Applications

Bioactivity

Product Specifications

Source

Chinese Hamster Ovary cell line, CHO-derived human BMP-2 protein
Gln283-Arg396
Manufactured and tested under current Good Manufacturing Practice (GMP) guidelines.

Purity

>95%, by SDS-PAGE with silver staining, under reducing conditions.

Endotoxin Level

<0.10 EU per 1 μg of the protein by the LAL method.

N-terminal Sequence Analysis

Gln-Ala-Lys-His-Lys-Gln-Arg-Lys-Arg-Leu

Predicted Molecular Mass

13 kDa (monomer)

SDS-PAGE

15-16, kDa, reducing conditions

Activity

Measured by its ability to induce alkaline phosphatase production by ATDC5 mouse chondrogenic cells. Binnerts, M.E. et al. (2004) Biochem. Biophys. Res. Commun. 315(2):272.
The ED50 for this effect is 40-200 ng/mL.
The specific activity of recombinant human BMP-2 is >5.0 x 105 units/mg, which is calibrated against the human BMP-2 WHO Standard (NIBSC code: 93/574).

Host Cell Protein

< 0.5 ng per µg of protein when tested by ELISA.

Mycoplasma

Negative when tested in a ribosomal RNA hybridization assay.

Scientific Data Images for Recombinant Human BMP-2 GMP Protein, CF

Recombinant Human BMP-2 GMP Protein Bioactivity

Recombinant Human BMP-2 GMP Protein Bioactivity

GMP-grade Recombinant Human BMP-2 (Catalog # 355-GMP) induces alkaline phosphatase production in the ATDC5 mouse chondrogenic cell line. The ED50 for this effect is 40-200 ng/mL. Three independent lots were tested for activity and plotted on the same graph to show lot-to-lot consistency of GMP BMP-2.
Recombinant Human BMP-2 GMP Protein SDS-PAGE

Recombinant Human BMP-2 GMP Protein SDS-PAGE

1 μg/lane of GMP-grade Recombinant Human BMP-2 (Catalog # 355-GMP) was resolved with SDS-PAGE under reducing (R) and non-reducing (NR) conditions and visualized by silver staining, showing single bands at 15 kDa and 30 kDa, respectively.

Formulation, Preparation and Storage

355-GMP
Formulation Lyophilized from a 0.2 μm filtered solution in Glycine, Sucrose, Tween® 80 and Glutamic Acid.
Reconstitution Reconstitute at 100 μg/mL in 4 mM HCl.
Shipping The product is shipped with polar packs. 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 12 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.

Background: BMP-2

Bone morphogenetic protein 2 (BMP-2) is a member of the BMP subgroup of the TGF-beta superfamily. It plays a dominant role in embryonic dorsal-ventral patterning, organogenesis, limb bud formation, and bone formation and regeneration (1, 2). Human BMP‑2 is synthesized as a 396 amino acid (aa) preproprotein that contains a 23 aa signal sequence, a 259 aa prosegment, and a 114 aa mature region (3). Proteolytic removal of the propeptide enables mature BMP-2 to form active disulfide linked homodimers and heterodimers with BMP-7 (2). Mature monomeric BMP-2 is an 18 kDa glycosylated peptide with seven conserved cysteines that form a cystine knot structure (4). Mature human BMP-2 shares 100% aa sequence identity with mouse and rat BMP-2. It shares 85% aa sequence identity with human BMP-4 and less than 51% with other BMPs. BMP-2 signals through heterodimeric complexes composed of a type I receptor (Activin RI, BMPR‑IA, or BMPR‑IB) and a type II receptor (BMP RII or Activin RIIB) (2, 5). BMP-2 induces chondrocyte proliferation, endochondral bone formation, longitudinal bone growth, and bone and cartilage repair (6, 7). It induces ectopic bone formation or calcification by promoting osteogenic and chondrogenic differentiation in mesenchymal cells, stem cells, and vascular smooth muscle cells (2, 8‑10). BMP-2/BMP-7 heterodimers are significantly more potent than BMP-2 homodimers at inducing bone formation in vivo (11). BMP-2 also promotes the maintenance and repair of colonic epithelium, suppresses neuronal dopamine synthesis and release, induces apoptosis in medulloblastoma cells, and is required for cardiac contractility (12‑15).

References

  1. Kishigami, S. and Y. Mishina (2005) Cytokine Growth Factor Rev. 16:265.
  2. Chen, D. et al. (2004) Growth Factors 22:233.
  3. Wozney, J. et al. (1988) Science 242:1528.
  4. Sun, P.D. and D.R. Davies (1995) Annu. Rev. Biophys. Biomol. Struct. 24:269. 
  5. Sebald, W. et al. (2004) Biol. Chem. 385:697.
  6. De Luca, F. et al. (2001) Endocrinology 142:430.
  7. Davidson, E.N.B., et al. (2007) Arthritis Res. Ther. 9:R102.
  8. Ryoo, H.-M. et al. (2006) Gene 366:51.
  9. Kramer, J. et al. (2000) Mech. Dev. 92:193.
  10. Li, X. et al. (2008) Atherosclerosis January 5 epub.
  11. Zhu, W. et al. (2004) J. Bone Miner. Res. 19:2021.
  12. Peiris, D. et al. (2007) Am. J. Physiol. Gastrointest. Liver Physiol. 292:G753.
  13. Kano, Y. et al. (2005) Endocrinology 146:5332.
  14. Hallahan, A.R. et al. (2003) Nat. Med. 9:1033.
  15. Wang, Y.-X. et al. (2007) Cardiovasc. Res. 74:290.

Long Name

Bone Morphogenetic Protein 2

Alternate Names

BDA2, BMP2, SSFSC

Entrez Gene IDs

650 (Human); 12156 (Mouse); 29373 (Rat)

Gene Symbol

BMP2

UniProt

Additional BMP-2 Products

Product Documents for Recombinant Human BMP-2 GMP Protein, CF

Certificate of Analysis

To download a Certificate of Analysis, please enter a lot number in the search box below.

Note: Certificate of Analysis not available for kit components.

Manufacturing Specifications

GMP Proteins
R&D Systems, a Bio-Techne Brand's GMP proteins are produced according to relevant sections of the following documents: USP Chapter 1043, Ancillary Materials for Cell, Gene and Tissue-Engineered Products and Eu. Ph. 5.2.12, Raw Materials of Biological Origin for the Production of Cell-based and Gene Therapy Medicinal Products.


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 testing according to USP
  • 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.

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 for Recombinant Human BMP-2 GMP Protein, CF

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.

We suggest you print and retain a copy of these End User Terms of Use of Product for your records.

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.

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.

You agree to review these End User Terms of Use of Product to ensure any subsequent use by you of R&D Systems' GMP Products following changes to these End User Terms of Use of Product constitutes your acceptance of all such changes.

 

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.

For preclinical, or clinical ex vivo use

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