PIXOTEFGENE ADRECEL
UNII 362MG83XWH

Substance Identification & Data

This profile provides standardized clinical and technical data for Pixotefgene Adrecel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) 362MG83XWH.

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

362MG83XWH

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

PIXOTEFGENE ADRECEL

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

INN ID

13716

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Pixotefgene Adrecel

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

Synonyms and Nomenclature

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

Pixotefgene Adrecel

Common Names & Synonyms

irradiated allogeneic human GP2-293 cells (derived from the human embryonic kidney cell line HEK-293) transduced with a Moloney murine leukaemia virus (MMLV)-derived vector encoding modified human transforming growth factor beta-1 (TGF-β1) with transcription under control of a cytomegalovirus (CMV) promoter and terminated with an AATAAA polyadenylation signal. The vector genome also comprises a 5' long terminal repeat (LTR), splice donor (SD), viral packaging signal (ψ), splice acceptor (SA), and a 3' LTR. The vector is pseudotyped with vesicular stomatitis virus (VSV) envelope glycoprotein G. The GP2-293 cell line was transduced with the MMLV vector encoding the transgene. A single clone was selected and further expanded to generate a master cell bank (MSC) and a working cell bank (WCB). Cells derived from the WCB were expanded in media supplemented with fetal bovine serum, in the absence of antibiotics and under 2D culture conditions using type I collagen-coated culture vessels. The final cellular component was irradiated to render the cells replication-incompetent. The cells have the same DNA profile as HEK-293 cells, express the modified human TGF-β1 protein, and similar epithelial surface markers as HEK-293 and GP2-293 cell lines, including CD324, CD147 and ephrin type-A receptor 2 (EphA2

pixotefgene adrecel [INN]

External Clinical & Regulatory Resources

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