PIXOTEFGENE ADRECEL

UNII:	362MG83XWH
Type:	INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:	PIXOTEFGENE ADRECEL
GSRS Full Record:	362MG83XWH i

Pixotefgene Adrecel
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]

Inxight Drugs
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UNIIs are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication. Please report any problems/errors associated with this data to FDA-SRS@fda.hhs.gov.

PIXOTEFGENE ADRECEL

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