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Denosumab

Product NameDenosumab

Introduction:

This   product is the biosimilar of Denosumab (615258-40-7), which is a human IgG2 monoclonal antibody that binds to   human RANKL. Denosumab has an approximate molecular weight of 147 kDa and is   produced in genetically engineered mammalian (Chinese hamster ovary) cells.

*Statement: this product   is used for R&D and IND only, not for clinical and commercial usage   before registered in drug registration authority.

Features and Advantages:

NameDenosumabCAS     NO.615258-40-7TypeWhole     antibodySourceHumanTargetRANK     ligandCloneMonocloneMolecular     Weight147 kDaFormulaC6404H9912N1724O2004S50Antibody     FormPurified immunoglobulinPhysical     FormSolutionPlace     of OriginUSAStorageSealed and stored     at -70±15℃, away     from light


Specifications:

The   Denosumab is supplied at 2mg/tube, 5mg/tube, 10mg/tube, 20mg/tube as a   sterile, clear and colorless, preservative-free solution.

质量保障 Quality Assurance

(1)   We have advanced technology and equipment to satisfy the requirements of GMP.   All the raw material purchasing and production quality control are strictly   following the ISO9001.

(2)   We own a group of QCs with rich experience, mainly engaging in testing APIs,   intermediates and finished products. Before posting, all of the stuffs must   receive professional training and GMP courses.

(3)   The COA(Certificate of Analysis), MOA(Method of Analysis), SDS(Stability Data   Sheet), DMF(Drug Master File) and MSDS(Material Safety Data Sheet) are   available.

 


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