Establishment of a robust GMP-ready technology platform for large-scale Transient Gene Expression for the manufacture of clinical grade protein pharmaceuticals.

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Projektnummer

10563.1;4 PFLS-LS

Projekttitel

Establishment of a robust GMP-ready technology platform for large-scale Transient Gene Expression for the manufacture of clinical grade protein pharmaceuticals.

Projekttitel Englisch

Establishment of a robust GMP-ready technology platform for large-scale Transient Gene Expression for the manufacture of clinical grade protein pharmaceuticals.

Texte zu diesem Projekt

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Kurzbeschreibung	-	-	-
Abstract	-	-	-

Erfasste Texte

Kategorie	Text
Kurzbeschreibung (Englisch)	Establishment of a robust GMP-ready technology platform for large-scale Transient Gene Expression for the manufacture of clinical grade protein pharmaceuticals.
Abstract (Englisch)	Manufacture of protein drugs by cultivated mammalian cells relies on the generation of stable lines made through a lengthy/costly procedure (months). By transient gene expression gram-amounts of recombinant protein can be made now in days. In spite of this, transient gene expression (TGE) is not applied for manufacture of clinical products. The goal of this project is to establish (at least part of) the GMP knowledge basis and technology required to obtain eventual regulatory approval for use of TGE in manufacturing. Baldi et al 2005, Stettler et al 2007, Wulhfard et al 2008, Backliwal et al 2008a, b.

Kategorie

Text

Kurzbeschreibung
(Englisch)

Establishment of a robust GMP-ready technology platform for large-scale Transient Gene Expression for the manufacture of clinical grade protein pharmaceuticals.

Abstract
(Englisch)

Manufacture of protein drugs by cultivated mammalian cells relies on the generation of stable lines made through a lengthy/costly procedure (months). By transient gene expression gram-amounts of recombinant protein can be made now in days*. In spite of this, transient gene expression (TGE) is not applied for manufacture of clinical products. The goal of this project is to establish (at least part of) the GMP knowledge basis and technology required to obtain eventual regulatory approval for use of TGE in manufacturing. * Baldi et al 2005, Stettler et al 2007, Wulhfard et al 2008, Backliwal et al 2008a, b.