Mycoplasma detection in cell therapy products: GMP-compliant implementation & validation of a commercial real-time PCR assay for routine quality control & lot release

Abstract

<b>Watch the video or read the poster to learn:</b> <ul><li>Regulatory guidance around mycoplasma testing in advanced cell therapy medicinal products</li><li>Factors to consider when choosing a rapid mycoplasma detection solution for use in lot-release testing for cell therapy products</li><li>GMP-compliant validation study design and results in a hMSC cell therapy product</li></ul><div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Valentina photo 200x200.jpg" data-image="1"></div><div class="author-det"> Valentina has a master's degree in medical and pharmaceutical biotechnologies, and recently gained a PhD in biochemistry and clinical pathology at the University of Florence, Italy. She has worked since 2010 as a senior&nbsp; scientist in the field of advanced therapy medicinal products (ATMPs) with special focus on drafting and execution of analytical validation protocols, in compliance with international requirements. During her 10 years as medical and pharmaceutical biotechnologist, Valentina has gained experience in process development, technology transfer, process validation, manufacturing, and biological characterization of cell-based products.&nbsp; </div></div></div>