GLP: A requirement in cell therapies - perspectives for the cardiovascular field

Ulrike Müller-Ruch; Anna Skorska; Heiko Lemcke; Gustav Steinhoff; Robert David

doi:10.1016/j.addr.2020.04.003

GLP: A requirement in cell therapies - perspectives for the cardiovascular field

Adv Drug Deliv Rev. 2020:165-166:96-104. doi: 10.1016/j.addr.2020.04.003. Epub 2020 Apr 16.

Authors

Ulrike Müller-Ruch¹, Anna Skorska¹, Heiko Lemcke¹, Gustav Steinhoff¹, Robert David²

Affiliations

¹ Department 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.
² Department 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. Electronic address: robert.david@med.uni-rostock.de.

PMID: 32305352
DOI: 10.1016/j.addr.2020.04.003

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.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Cardiovascular Diseases / drug therapy
Drug Development / organization & administration*
Drug Development / standards
Drug Discovery / organization & administration*
Drug Discovery / standards
Drug Evaluation, Preclinical / methods*
Drug Evaluation, Preclinical / standards
Guidelines as Topic
Humans
Laboratories / organization & administration*
Laboratories / standards