BETIBEGLOGENE AUTOTEMCEL

UNII:	MEE8487RTP
Type:	INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:	BETIBEGLOGENE AUTOTEMCEL
GSRS Full Record:	MEE8487RTP i

AUTOLOGOUS CD34+ CELLS ENCODING .BETA.A-T87Q-GLOBIN GENE
AUTOLOGOUS CD34+ ENRICHED CELL POPULATION THAT CONTAINS HEMATOPOIETIC STEM CELLS (HSC'S) TRANSDUCED WITH THE LENTIGLOBIN BB305 LENTIVIRAL VECTOR (LVV) ENCODING FOR THE .BETA.A-T87Q-GLOBIN GENE. THE CD34+ ENRICHED CELL POPULATION CONTAINING HEMATOPOIETIC STEM AND PROGENITOR CELLS IS OBTAINED FROM AUTOLOGOUS PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMCS)
BB-305
BETIBEGLOGENE AUTOTEMCEL [USAN]
Betibeglogene autotemcel [WHO-DD]
LENTIGLOBIN BB305
ZYNTEGLO
autologous CD34+ hematopoietic stem cells obtained from mobilised peripheral blood of patients with beta-thalassemia, transduced ex vivo with betibeglogene darolentivec (116)(78), a self-inactivating human immunodeficiency virus-1 (HIV-1)-derived lentiviral vector encoding a T87Q-mutated form of the human hemoglobin subunit beta (HBB, beta-globin) gene under the control of a human β-globin promoter and a 3' β-globin enhance
betibeglogene autotemcel [INN]

Note

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.

BETIBEGLOGENE AUTOTEMCEL

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