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Ranibizumab

Product NameRanibizumab

Introduction:

This   product is the biosimilar of Ranibizumab (347396-82-1), which is a recombinant   humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular   use. The biosimilar binds to and inhibits the biologic activity of human vascular   endothelial growth factor A (VEGF-A), which lacks an Fc region, has a   molecular weight of approximately 48 kilodaltons and is produced by an E.   coli expression system in a nutrient medium.

*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:

NameRanibizumabCAS     NO.347396-82-1TypeFab     fragmentSourceHumanized (from mouse)TargetVEGF-ACloneMonocloneMolecular     Weight48 kDaFormulaC2158H3282N562O681S12Antibody     FormPurified immunoglobulinPhysical     FormSolutionPlace     of OriginUSAStorageSealed and stored     at -70±15℃, away     from light


Specifications:

The   Ranibizumab 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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