Sartorius Stedim Japan K.K. Official site

[On-Demand Viewing Available] Webinar "Rapid Sterility Testing in ATMPs Using qPCR Before Treatment Initiation"

Sartorius Stedim Japan K.K.

Participation in this webinar has ended. Those who wish to access the on-demand version can register for details and viewing. Contaminated regenerative medicine products and gene therapy products (Advanced Therapy Medicinal Products: ATMP) pose a risk to the lives of patients receiving treatment. The current international pharmacopoeia requires 14 days for sterility testing, but the typical shelf life of an ATMP is 48 hours. We have developed a qPCR testing method that can detect bacterial and fungal contamination in just under 3 hours before treatment begins. In this webinar, we will present a validation study designed to evaluate the detection capabilities of bacteria and fungi in accordance with EP 5.1.6, USP <1223>, and <1071>. [Related Homepage] https://www.sartorius.com/en/applications-jp/quality-control-testing-jp/microbiological-quality-control-jp/rapid-testing-jp/bacterial-detection-jp