The 2nd 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 by renowned academic leaders in the field of mycoplas-mology, leading industrial experts, and experts from regulatory agencies.
Conference Topics
- Mycoplasma Biology, Taxonomy, Ecology, Biodiversity and Pathogenicity
- Cell-Invasive Mycoplasmas
- Haemotrophic Mycoplasmas
- Mycoplasma Biofilms and their Role in Environmental Persistence and Survival
- Mycoplasma Infections of Cell Cultures: Implications for Biomedical and Biotechnological Research
- Mycoplasma Contaminations of Cell Lines and in Manufacturing Operations
- Monitoring for Mycoplasma Contamination of Cell Cultures: A Requirement for Scientific Accuracy of Research Data
- A Case Study on Mycoplasma Contamination in a Biotech Cell Culture Facility
- Risk Minimization Strategy for Mycoplasma Contamination in Biopharmaceutical and Biotechnological Processes by Filtration Technologies
- Mycoplasma Biosafety of Advanced Cell Therapy Products
- Mycoplasma Biosafety Testing of Biologicals: Comparison of the Current US, European and Japanese Regulations
- Standardization of NAT-Based Mycoplasma Detection Assays: Reference Preparations and Test Validation
- Rapid Detection and Identification of Mycoplasma Contamination in the Manufacture of Biological Products: Development, Validation, Regulatory Compliance and Experiences from Routine Application of Current Commercial and Non-Commercial Culture- and NAT-Based Approaches
Keynote Speakers
- Leonard Hayflick, University of California, San Francisco, CA, USA
- Shlomo Rottem, The Hebrew University, Jerusalem, Israel
- Thomas Montag-Lessing, Paul-Ehrlich-Institut, Langen, Germany
Download conference flyer here 
Download final conference agenda here
Who Should Attend
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.
The 2nd International Mycosafe Symposium should therefore not be missed by scientists and professionals from
- Biotechnological, Biopharmaceutical & Biotherapeutical Companies
- Contract Service Laboratories
- Academic Research Institutions and Organizations
- Government Agencies
- Cell Culture Collections with responsibilities in Research & Development
- Manufacturing
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Process Development
- Validation
Objectives & Take Home Benefits
- Understand the role of mycoplasmas as agents of infection and disease and as cell culture contaminants
- Learn from case studies the profound impact of mycoplasma cell culture contamination on biotechnological research and biopharmaceutical manufacturing
- Learn from basic mycoplasma research studies the capability of mycoplasmas of long-term environmental persistence and survival through intracellular residence and biofilm formation
- Recognize the challenges of mycoplasma biosafety control of biological products using the standard culture and alternative NAT-based procedures according to the current regulatory guidelines for mycoplasma testing
- Discuss with experts and users the advantages and limitations of recently developed NAT-based mycoplasma detection assays compared to the standard culture procedures
- Learn from recent validation studies of NAT-based mycoplasma detection assays the need to incorporate well-defined mycoplasma reference standard preparations into the study design in order to meet the regulatory requirements
- Understand the need to implement regulatory mycoplasma testing for mycoplasma biosafety control of advanced cell therapy products