Торулимоген лонфертел

Rec. INN (наименование, зарегистрированное ВОЗ)

irradiated human embryonic kidney cells (cell line HEK293) transfected with three self-inactivating, non-replicating lentiviral vectors individually expressing (i) codon-optimised Wilms tumour protein 1 (WT1) isoform D, (ii) codon-optimised cluster of differentiation 1d (CD1d), and (iii) a codon-optimised reverse tetracycline-controlled transactivator (rtTA), a fusion protein of the TetR repressor and the herpes simplex virus VP16 transactivation domain. Expression of both CD1d and rtTA is controlled by the cytomegalovirus immediate early (CMV IE) promoter; expression of WT1 is controlled by an inducible Tet responsive promoter (TRE). Each lentivirus vector also contains a packaging signal (Ψ), a Rev-response element (RRE), a central polypurine tract/central termination sequence (cPPT/CTS) and a Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE), and are flanked by a 5' long terminal repeat (LTR) and a 3' self-inactivating long terminal repeat (SIN-LTR).
Colonies of transfected cells (expression of CD1d) were established as a Master cell bank (MCB). For the drug substance, cells are expanded and then doxycycline added to induce WT1 in the presence of α-galactosylceramide (α-GalCer), which binds to CD1d forming a CD1d/α-GalCer complex on the cell surface. Finally, the cells are subject to X-ray irradiation. The cells express CD1d (>90%) and intracellular WT1 and the ratio of Cd1d to α-GalCer is determined.

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