BERETEMCEL
UNII YSW8E5EV4Q

Substance Identification & Data

This profile provides standardized clinical and technical data for Beretemcel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) YSW8E5EV4Q.

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

YSW8E5EV4Q

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

BERETEMCEL

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

NCI Thesaurus

C206882

National Cancer Institute reference terminology for clinical and research data.

INN ID

12993

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

structurallyDiverse

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

ITIS TSN

180092

Taxonomic Serial Number for species identified in the Integrated Taxonomic Information System.

NCBI Taxonomy

9606

Unique numeric identifier used to specify biological species in the NCBI database.

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Beretemcel. 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

BERETEMCEL

Common Names & Synonyms

ALLOGENEIC STEM CELLS DERIVED FROM DONOR ADULT LIVER TISSUE. THE LIVER BIOPSY IS DIGESTED, AND THE RELEASED CELLS PLACED IN CULTURE MEDIA CONTAINING FETAL BOVINE SERUM (FBS), FIBROBLAST GROWTH FACTOR-2 (FGF-2) AND EPIDERMAL GROWTH FACTOR (EGF). THE CELLS ARE FROZEN TO GENERATE A MASTER CELL BANK (MCB) AT AN EARLY PASSAGE, AND THEN RESUSCITATED AND CULTURE-EXPANDED. THE CELLS ARE CHARACTERIZED AS ADHERENT WITH AN ELONGATED MORPHOLOGY, THE PRESENCE (>=70%) OF CELLULAR MARKERS CD29, CD73, CD90, CD105, CD44 AND ALBUMIN, AND THE ABSENCE OF CD34 (<5%), CD45 (<2%) AND CD14 (<5%). THE CELLS DIFFERENTIATE INTO FUNCTIONAL HEPATOCYTES IN A ROTARY CELL CULTURE SYSTEM IN MEDIA CONTAINING FETAL CALF SERUM (FCS), HEPATOCYTE GROWTH FACTOR (HGF), AND FIBROBLAST GROWTH FACTOR 4 (FGF4) WITH THE ABILITY TO TRANSPORT INDOCYANINE GREEN

BERETEMCEL [INN]

External Clinical & Regulatory Resources

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