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Eculizumab

Product NameEculizumab

Introduction:

This   product is the biosimilar of Eculizumab (219685-50-4), which is a recombinant   humanized monoclonal IgG2/4κ antibody produced by Chinese hamster ovary cell   culture and purified by standard bioprocess technology. Eculizumab contains   human constant regions from human IgG2 sequences and human IgG4 sequences and   murine complementarity-determining regions grafted onto the human framework   light- and heavy-chain variable regions. The biosimilar is composed of two   448 amino acid heavy chains and two 214 amino acid light chains and has a   molecular weight of approximately 148 kDa.

*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:

NameEculizumabCAS     NO.219685-50-4TypeWhole     antibodySourceHumanized (from mouse)TargetComplement     protein C5CloneMonocloneMolecular     Weight148 kDaAntibody     FormPurified immunoglobulinPhysical     FormSolutionPlace     of OriginUSAStorageSealed and stored     at -70±15℃, away     from light


Specifications:

The   Eculizumab 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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