Real-Time PCR-Based Mycoplasma Testing – Verification for the Intended Use: Data from a User
Webinar duration: 29 minutes
Overview
The webinar addresses challenges and solutions in Mycoplasma detection for Advanced Therapy Medicinal Products (ATMPs). Real-time PCR is the gold standard for Mycoplasma testing due to its high sensitivity and specificity, but high cell density can interfere with results. The Microsart® ATMP Mycoplasma Kit, combined with the Microsart® AMP Extraction Kit, offers a streamlined solution with results in approximately 3.5 hours.
The presentation details a customer validation processes of high cell count samples (26M MSC/mL). It highlights protocol optimization and successful detection of Mycoplasma species in spiked samples, demonstrating the kit's effectiveness. These advanced testing methods support the safety and efficacy of regenerative therapies while meeting regulatory requirements.
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In This Webinar You Will Learn:
- How to handle high cell density background in Mycoplasma contamination detection
- Successful validation data from a customer
- How Sartorius provides support for optimizing protocols
- PCR-based Mycoplasma testing offers many advantages over traditional growth-based testing
Webinar Speakers
Natalie Schmitz
Scientist, PCR & Microbiology Applications, Sartorius
Natalie gained her first experience in the laboratory environment with the start of her training as a biology laboratory technician in 2016, followed by a Bachelor's degree in Biomedical Science in the Netherlands and a Master's degree in Biotechnology in Aachen, which led her to her first scientist position here at Sartorius in the PCR and Microbiology application development team.
Michael Joyce
Director, R&D, BioRestorative Therapies
Michael Joyce is the Director of R&D for Biorestorative Therapies. His previous research was focused on 3D printing mechanically reinforced and gene activated biomaterials for the repair of large area, load bearing articular cartilage defects with the Royal College of Surgeons in Ireland.