Safety assays for quality control of ATMPs: improved mycoplasma detection for cell-based biotherapeutics
Sponsor
Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.
Process development and manufacturing of ATMPs is complex and requires multiple quality control checkpoints to identify potential pathogens and impurities. Mycoplasma detection is a fundamental component of safety assays, this is why the different Pharmacopeias worldwide have established stringent guidelines to ensure therapeutic products remain free from contamination.
This webinar will explore safety assays for cell-based biotherapeutics, mycoplasma testing strategies and the advantages of applying robust and sensitive RT-dPCR method. Unlike traditional solutions such as broth/agar culture or staining, dPCR offers a consistent and highly reproducible solution without the need for standard curves. The speakers will also present supporting data to demonstrate how rRNA-based detection enables a higher sensitivity compared to DNA-based methods due to the multiple copies of rRNA present in a single bacterial cell.
Attendees will gain insights into mycoplasma risk management and how dPCR can accelerate safety assessment, support regulatory compliance, and ultimately ensure the safe and timely delivery of advanced therapeutics to patients.
- Gain insights on implementing advanced molecular assays to quickly and reliably identify mycoplasma contamination and enable timely adjustment or even batch rejection
- Learn about the safety testing strategies, mycoplasma contamination risk management and available assays for biotherapeutic manufacturing
- Discover the benefits of using highly sensitive and reproducible detection with one-step RT-dPCR chemistry
SPEAKERS
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