Good Cell Culture Practice for stem cells and stem-cell-derived models

Knowledge Source Identification
Knowledge source name Good Cell Culture Practice for stem cells and stem-cell-derived models
Owner/Developer Alternatives to Animal Experimentation
Abbreviated owner ALTEX
Country Switzerland
Languages English
Description The first guidance on Good Cell Culture Practice dates back to 2005. This document expands this to aspects of quality assurance for in vitro cell culture focusing on the increasingly diverse cell types and culture formats used in research, product development, testing and manufacture of biotechnology products and cell-based medicines. It provides a set of basic principles of best practice which can be used in training new personnel, reviewing and improving local procedures, and helping to assure standard practices and conditions for the comparison of data between laboratories and experimentation performed at different times. This includes recommendations for the documentation and reporting of culture conditions. It is intended as guidance, which will facilitate the generation of reliable data from cell culture systems, but is not intended to conflict with local or higher level legislation or regulatory requirements. It may not be possible to meet all recommendations in this guidance for practical, legal or other reasons. However, when necessary to divert from the principles of GCCP, the risk of decreasing the quality of work and safety of laboratory staff should be addressed and any conclusions or alternative approaches justified. This workshop report is considered as a first step toward a revised GCCP 2.0.
Knowledge Source Category
Category Publication
Sub categories Report
Knowledge Dissemination and Sharing
Dissemination channel Website, Printed
Targeted audience (specified/objective analysis) Scientists, Policy-makers, Regulators, Industry, Researchers, Educators, Students
Users access Open access
Knowledge Characterization
3Rs relevance Replacement
Purpose Method development, Documentation and information
Technology/Tools Alternative test methods (in vitro), Stem cells