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Product NameAlirocumab

产品描述 Introduction:

This product is the   biosimilar of Alirocumab (1245916-14-6), which   is a human monoclonal antibody that targets   proprotein convertase subtilisin kexin type 9 (PCSK9). It is a PCSK9   inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary   cell suspension culture, which consists of two disulfide-linked human heavy   chains, each covalently linked through a disulfide bond to a human kappa   light chain. A single Nlinked glycosylation site is located in each heavy   chain within the CH2 domain of the Fc constant region of the molecule. The   variable domains of the heavy and light chains combine to form the PCSK9   binding site within the antibody. Molecular weight is approximate 146 kDa.  

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

特点和优势   Features and Advantages:

NameAlirocumabCAS     NO.1245916-14-6TypeWhole     antibodySourceHumanTargetPCSK9CloneMonocloneMolecular     Weight146 kDaFormulaC6472H9996N1736O2032S42Antibody     FormPurified immunoglobulinPhysical     FormSolutionPlace     of OriginUSAStorageSealed and stored     at -70±15℃, away     from light

规格   Specifications:

The   Alirocumab 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.