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Updated: Dec 23, 2025
Author Spotlight: Advancing Cell Therapy Manufacturing with Dissolvable Microcarriers
Published on: July 7, 2023
GLP: A requirement in cell therapies - perspectives for the cardiovascular field
Ulrike Müller-Ruch1, Anna Skorska1, Heiko Lemcke1
1Department of Cardiac Surgery, Reference and Translation Center for Cardiac Stem Cell Therapy (RTC), University Medical Center Rostock, 18057 Rostock, Germany; Faculty of Interdisciplinary Research, Department Life, Light & Matter, University Rostock, 18059 Rostock, Germany.
Abstract:
In biomedical research, enormous progress is being made and new candidates for putative medicinal products emerge. However, most published preclinical data are not conducted according to the standard Good Laboratory Practice (GLP). GLP is mandatory for preclinical analysis of Advanced Therapy Medicinal Products (ATMP) and thereby a prerequisite for planning and conduction of clinical trials. Not inconsiderable numbers of clinical trials are terminated earlier or fail - do inadequate testing strategies or missing specialized assays during the preclinical development contribute to this severe complex of problems? Unfortunately, there is also a lack of access to GLP testing results and OECD (Organisation for Economic Co-operation and Development) GLP guidelines are not yet adjusted to ATMP specialties. Ultimately, GLP offers possibilities to generate reliable and reproducible data. Therefore, this review elucidates different GLP aspects in drug development, speculates on reasons of putative low GLP acceptance in the scientific community and mentions solution proposals.
