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Infliximab

Product NameInfliximab

Introduction:

This   product is the biosimilar of Infliximab (170277-31-3), which is a chimeric   IgG1κ monoclonal antibody (composed of human constant and murine variable   regions) specific for human tumor necrosis factor-alpha (TNFα). It has a   molecular weight of approximately 149.1 kilodaltons. The biosimilar is   produced by a recombinant cell line cultured by continuous perfusion and is   purified by a series of steps that includes measures to inactivate and remove   viruses.

*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:

NameInfliximabCAS     NO.170277-31-3TypeWhole     antibodySourceChimeric (mouse/human)TargetTNF     alphaCloneMonocloneFormulaC6428H9912N1694O1987S46Molecular     Weight149 kDaAntibody     FormPurified immunoglobulinPhysical     FormSolutionPlace     of OriginUSAStorageSealed and stored     at -70±15℃, away     from light


Specifications:

The   Infliximab 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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