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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Spotlight Article

Need for regulatory compliance in research: what is Good Laboratory Practice and what is a validated assay?

Meeting Preclinical Data Requirements For Cell & Gene Therapies

Lincoln Tsang

Development and evaluation of a new therapeutic product is an iterative stepwise process involving a programme of studies to establish the safety, quality and efficacy of the product and to define its safe and effective conditions. The non-clinical and quality testing is designed to characterise the pharmacodynamics, pharmacokinetics, pharmaco-toxicology of a candidate drug molecule as well as its quality attributes such as strength and potency. The testing data provide the scientific basis for planning and initiating the clinical development of the drug candidate. It has been a vexing question for researchers performing non-clinical studies as to whether all such studies in research and development should be conducted within the framework for Good Laboratory Practice (‘GLP’). In a regulatory context, to what extent should such assays be validated and against what criteria. This article seeks to address these related regulatory questions.

DOI: 10.18609/cgti.2019.098
Citation: Cell & Gene Therapy Insights 2019; 5(7), 885-891.
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