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Daratumumab

Product NameDaratumumab

Introduction:

This product is the biosimilar of Daratumumab (945721-28-8), which is an   immunoglobulin G1 kappa (IgG1κ) human monoclonal antibody against CD38   antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO])   using recombinant DNA technology. The molecular weight of the biosimilar is   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:

NameDaratumumabCAS     NO.945721-28-8TypeWhole     antibodySourceHumanTargetCD38CloneMonocloneMolecular     Weight148 kDaFormulaC6466H9996N1724O2010S42Antibody     FormPurified immunoglobulinPhysical     FormSolutionPlace     of OriginUSAStorageSealed and stored     at -70±15℃, away     from light


Specifications:

The Daratumumab   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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