BERETEMCEL

UNII:	YSW8E5EV4Q
Type:	INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:	BERETEMCEL
GSRS Full Record:	YSW8E5EV4Q i

Beretemcel
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]

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.

BERETEMCEL

Synonyms and Mappings

Resources