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Cetuximab

Product NameCetuximab

Introduction:

This   product is the biosimilar of Cetuximab (205923-56-4), which is a recombinant,   human/mouse chimeric monoclonal antibody that binds specifically to the extracellular   domain of the human epidermal growth factor receptor (EGFR). This biosimilar   is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1   heavy and kappa light chain constant regions and has an approximate molecular   weight of 152 kDa, which 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:

NameCetuximabCAS     NO.205923-56-4TypeWhole     antibodySourceChimeric (mouse/human)TargetEGF     receptorCloneMonocloneFormulaC6484H10042N1732O2023S36Molecular     Weight152 kDaAntibody     FormPurified immunoglobulinPhysical     FormSolutionPlace     of OriginUSAStorageSealed and stored     at -70±15℃, away     from light


Specifications:

The   Cetuximab 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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