Pre-made Dinutuximab benchmark antibody ( Whole mAb, anti-Ganglioside GD2 therapeutic antibody) for drug discovery and mechanism of action (MOA) research

Cat No.: GMP-Bios-ab-146

Pre-Made Dinutuximab biosimilar, Whole Mab: Anti-Ganglioside GD2 therapeutic antibody is a biosimilar expressed by mammalian cell line as a benchmark reference therapeutic antibody for biological drug disovery items including cell culture, assay development, animal model development, PK/PD model development (Pharmacokinetics & Pharmacodynamic) and mechanism of action (MOA) research.

Dinutuximab (Ch14.18, tradename Unituxin) and Dinutuximab beta (tradename Qarziba) are monoclonal antibodies used as a second-line treatment for children with high-risk neuroblastoma. Each antibody is made of both mouse and human components and targets glycolipid GD2, expressed on neuroblastoma cells and on normal cells of neuroectodermal origin, including the central nervous system and peripheral nerves. They differ in that dinutuximab is manufactured using mouse cells, and dinutuximab beta is manufactured using hamster cells. The dosing regime differs, and dinutuximab is given in combination with granulocyte-macrophage colony stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), while dinutuximab beta can be given alone.

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Description

Products Name (INN Index) Pre-Made Dinutuximab biosimilar, Whole Mab: Anti-Ganglioside GD2 therapeutic antibody
INN Name Dinutuximab
TargetGanglioside GD2
FormatWhole mAb
DerivationChimeric (Mouse/Human)
Species ReactivityHuman
CH1 IsotypeIgG1
VD LCKappa
Highest_Clin_Trial (Jan '20)Approved
Est. StatusActive
100% SI StructureNone
99% SI StructureNone
95-98% SI Structure4tuj:CD:AB/4tul:HL/4trp:HL/4tuo:AB:CD/4tuk:HL
Year Proposed2013
Year Recommended2014
CompaniesNational Cancer Institute (USA);New Approaches to Neuroblastoma Therapy Consortium;St. John of God Foundation;United Therapeutics Corporation
Conditions ApprovedNeuroblastoma
Conditions ActiveSmall cell lung cancer
Conditions DiscontinuedMalignant melanoma
Development Techna