title: Validation of cell substrates used for human biologicals: An overview of international regulatory documents.
abstract: The acceptability of continuous cell lines as substrates for pharmaceutical products for human use has been a subject of controversy since 1978. In this paper the authors highlight the guidelines that the US FDA, European and Japanese regulatory agencies have issued in recent years regarding the characterization of the cell lines used as substrates, the validation of the purification process and the characterization of the product.
authors.affiliation: Istituto di Ricerche Biomediche "A. Marxer" RBM S.P.A., Via Ribes 1, I-10010 Colleretto Giacosa (TO), Italy.
authors.forename: P
authors.initials: P
authors.lastname: Zaninelli
authors.forename: D
authors.initials: D
authors.lastname: Barone