02701nas a2200361   4500000000100000000000100001008004100002260001500043653001600058100001700074700001900091700002300110700001800133700001900151700001800170700002000188700002600208700001900234700001800253700001700271700001800288700001900306700002300325700001900348700003300367700002100400245013500421856006000556300001200616490000700628520169000635022001402325       2018                            d  c2018-07-0910aorganotypic1 aDavid Pamies1 aAnna Bal-Price1 aChristophe Chesné1 aSandra Coecke1 aAndras Dinnyes1 aChantra Eskes1 aRegina Grillari1 aGerhard Gstraunthaler1 aThomas Hartung1 aPaul Jennings1 aMarcel Leist1 aUlrich Martin1 aRobert Passier1 aJens C. Schwamborn1 aGlyn N. Stacey1 aHeidrun Ellinger-Ziegelbauer1 aMardas Daneshian00aAdvanced Good Cell Culture Practice for human primary, stem cell-derived and organoid models as well as microphysiological systems  uhttps://www.altex.org/index.php/altex/article/view/1000  a353-3780 v353 aA major reason for the current reproducibility crisis in the life sciences is the poor implementation of quality control measures and reporting standards. Improvement is needed, especially regarding increasingly complex in vitro methods. Good Cell Culture Practice (GCCP) was an effort from 1996 to 2005 to develop such minimum quality standards also applicable in academia. This paper summarizes recent key developments in in vitro cell culture and addresses the issues resulting for GCCP, e.g., the development of induced pluripotent stem cells (iPSCs) and gene-edited cells. It further deals with human stem-cell-derived models and bioengineering of organotypic cell cultures, including organoids, organ-on-chip and human-on-chip approaches. Commercial vendors and cell banks have made human primary cells more widely available over the last decade, increasing their use but also requiring specific guidance as to GCCP. The characterization of cell culture systems including high-content imaging and high-throughput measurement technologies increasingly combined with more complex cell and tissue cultures represent a further challenge for GCCP. The increasing use of gene editing techniques to generate and modify in vitro culture models also requires discussion of its impact on GCCP. International (often varying) legislations and market forces originating from the commercialization of cell and tissue products and technologies are further impacting on the need for the use of GCCP. This report summarizes the recommendations of the second of two workshops, held in Germany in December 2015, aiming to map the challenge and organize the process or developing a revised GCCP 2.0.  a1868-8551