Webinar overview
Mycoplasma testing is a critical quality attribute for cellular therapeutics, yet traditional compendial methods require up to 28 days, which is too long for autologous cell therapies for critically ill patients. In this on-demand webinar, you will discover a newly developed and validated NAT-based mycoplasma testing solution that combines highly efficient automated or manual DNA extraction with a real-time RT-PCR assay. The system is designed to meet the updated regulatory requirements of Ph. Eur. chapter 2.6.7 (12.2) and USP <77>, enabling faster, reliable, and compliant mycoplasma detection.
Key takeaways:
- Understand the impact of revised Ph. Eur. 2.6.7 (12.2) and USP <77> on mycoplasma testing
- Learn how a rapid NAT-based assay with automated or manual DNA extraction can shorten release timelines
- See how real-time RT-PCR enables sensitive, compliant mycoplasma detection for cell therapy products
Resource details:
- Document type: Webinar
- Watch time: 47 minutes