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Evolocumab

Product NameEvolocumab

Introduction:

This   product is the biosimilar of Evolocumab (1256937-27-5), which is a human monoclonal   immunoglobulin G2 (IgG2) directed against human proprotein convertase   subtilisin kexin 9 (PCSK9). The biosimilar has an approximate molecular   weight (MW) of 144 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:

NameEvolocumabCAS     NO.1256937-27-5TypeWhole     antibodySourceHumanTargetPCSK9CloneMonocloneMolecular     Weight144 kDaFormulaC6242H9648N1668O1996S56Antibody     FormPurified immunoglobulinPhysical     FormSolutionPlace     of OriginUSAStorageSealed and stored     at -70±15℃, away     from light


Specifications:

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

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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