Addressing the risk presented by extractables and leachables in cell therapy manufacturing
Cell & Gene Therapy Insights 2023; 9(10), –1131
DOI: 10.18609/cgti.2023.149
Published: 19 March
Foreword
The identification and measurement of extractables and leachables (E&L) is a critical element of advanced therapy QC. David McCall (Senior Editor, BioInsights) speaks to Jason Creasey (Managing Director, Maven E&L Ltd) about regulators’ expectations and the importance of adopting a risk-based approach to E&L for cell therapy developers.