DUBODENCEL
UNII E2TVN7CU8C

Substance Identification & Data

This profile provides standardized clinical and technical data for Dubodencel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) E2TVN7CU8C.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number N/A and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code

E2TVN7CU8C

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

DUBODENCEL

Official standardized name for this substance within the FDA UNII nomenclature system.

NCI Thesaurus

C226926

National Cancer Institute reference terminology for clinical and research data.

INN ID

13974

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Dubodencel

ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Dubodencel. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

Dubodencel

Common Names & Synonyms

autologous dendritic cells (DCs) derived from a mobilized leukocytes apheresis collection obtained from glioblastoma or pancreatic ductal adenocarcinoma (PDAC) patients. Tumor tissue is obtained from the patient and processed to produce a patient-specific tumour cell lysate and amplified tumour mRNA. The monocytes are separated from the leukocyte apheresis material using counterflow centrifugal elutriation and are cultured in the presence of granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-4 (IL-4) to generate immature dendritic cells. Then, amplified tumour mRNA is delivered to the immature dendritic cells by electroporation after which the cells are cultured with the tumour lysate. Finally, the dendritic cells are matured through culture in media containing GM-CSF, IL-4, IL-1β, IL-6, tumour necrosis factor (TNF) and prostaglandin E 2 (PGE<sub>2</sub> ). The final cell suspension contains predominantly dendritic cells (CD11c+, HLA-DR+; at least >40%), with a low percentage of CD3+/CD11c- lymphocytes. The dendritic cells express CD83 antigen (>40%) as a marker of cell activation

dubodencel [INN]

External Clinical & Regulatory Resources

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