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Updated: Jun 10, 2026

Detection of Antibodies That Neutralize the Cellular Uptake of Enzyme Replacement Therapies with a Cell-based Assay
Published on: September 10, 2018
Validation of cell substrates used for human biologicals: An overview of international regulatory documents
1Istituto di Ricerche Biomediche "A. Marxer" RBM S.P.A., Via Ribes 1, I-10010 Colleretto Giacosa (TO), Italy.
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.
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