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

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

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 approximately 781 units/μg, which is calibrated against human BMP-2 WHO Standard (NIBSC code: 93/574).

Lyophilized from a 0.2 μm filtered solution in Glycine, Sucrose, Tween® 80 and Glutamic Acid.

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:

• Manufacturing and testing 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.

BMP-2; BMP-2A; BMP2ABone morphogenetic protein 2A; bone morphogenetic protein 2

Reconstitute at 100 μg/mL in 4 mM HCl.