The 2
nd International Mycosafe Symposium will review the current knowledge of the biology and ecology of mycoplasmas as agents of infection and disease and as contaminants of cell cultures and biological, and will particularly address the mycoplasma biosafety testing requirements of advanced cell therapy products, the current method validation approaches of NAT (nucleic acid amplification techniques)-based mycoplasma detection assays that allow more rapid testing and product release, and recent experiences with these new detection systems in product-specific test validation, comparability studies and routine mycoplasma testing.
The programme provides a unique scientific and learning opportunity as it will blend state-of-the-art information on the unusual biological features of mycoplasmas, and current strategies of their detection, prevention and control together with the newest technological developments and practical test validation aspects for meeting the regulatory requirements and science-driven expectations, as well as research and industry case studies that examine lessons learned from mycoplasma contamination situations. The programme particularly intends to overcome the currently existing misconception and confusion regarding the mycoplasma biosafety testing requirements of advanced cell therapy products, as well as the lack of information and knowledge regarding the regulatory compliant method performance and product-specific validation requirements including the application of well-defined mycoplasma reference standard preparations associated with recently developed NAT-based mycoplasma detection assays prior to their use in routine mycoplasma testing.
Presentations are given from renowned academic leaders in the field of mycoplas-mology, leading industrial experts, and experts from regulatory agencies.
The conference topics include:
- Mycoplasma biology, taxonomy and ecology
- The role of mycoplasmas as agents of infection and disease and as cell culture contaminants
- The impact of mycoplasma cell culture contamination on research and manufacturing
- Case studies that provide insight into mycoplasma contamination issues recently been encountered in biotechnological research and biopharmaceutical manufacturing
- The role of mycoplasma intracellular residence and biofilm formation in environmental persistence and survival
- Comparison of current mycoplasma biosafety testing methods
- Validation of rapid NAT (nucleic acid amplification techniques)-based mycoplasma detection systems according to regulatory requirements
- Mycoplasma reference standard requirements for validation of NAT-based mycoplasma detection assays
- Mycoplasma biosafety control of advanced cell therapy products
The programme is designed for anyone who is associated with biotechnological and biopharmaceutical processes and manufacturing, research and development based on cell culture systems, and advanced cell-based therapies. Whether renewing (scientific) acquaintances with mycoplasmas or exploring the world of mycoplasmas and the threat of mycoplasma contamination for the first time, this occasion which provides the opportunity to meet and network with the experts in the field will be undoubtedly profitable, stimulating and enjoyable.
