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Ofatumumab

Product NameMatuzumab

Introduction:

This   product is the biosimilar of Matuzumab   (339186-68-4), which is a humanized IgG1   monoclonal antibody against human EGFR. As it only has approximately 10%   murine origin it has limited immunogenicity, and being IgG1 it is capable of   inducing antibody dependent cell cytotoxicity (ADCC). The biosimilar   is produced in mammalian (Chinese hamster ovary) cell culture.

*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:

NameMatuzumabCAS     NO.339186-68-4TypeWhole     antibodySourceHumanizedTargetEGFRCloneMonocloneAntibody     FormPurified immunoglobulinPhysical     FormSolutionPlace     of OriginUSAStorageSealed and stored     at -70±15℃, away     from light


Specifications:

The   Matuzumab 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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