Course Description:
This webinar provides a technical overview for detecting Mycoplasma contamination within the biomanufacturing sector. It will review the newly developed USP General Chapter <77> Mycoplasma Nucleic Acid Tests. The webinar will highlight biological characteristics of mycoplasma and the evolution of mycoplasma testing approaches to include traditional culture, cell culture-based methods, and molecular (PCR-based) testing methods. The course will clarify the key expectations for primary validation and determining suitability methods. It also addresses critical metrics such as the GC-to-CFU ratio to ensure testing accuracy along with essential framework considerations for implementing routine molecular mycoplasma screening for GMP product release testing.
Upon completion of this course, you will be able to:
- Discuss the relevance of mycoplasma contaminations in biomanufacturing.
- Identify relevant elements of mycoplasma biology and taxonomy.
- Describe the key differences between mycoplasma testing per USP <63> and <77>, as well as the benefits of mycoplasma PCR testing.
- Summarize the underlying rationales for primary validation and method suitability requirements to include selection of relevant organisms for use case, selection of appropriate sources of materials, and sample volume considerations for limit of detection.
- Explain the rationale for maximum GC-to-CFU ratio.
- Summarize considerations for routine mycoplasma PCR testing including assay controls and sample controls.
Who Should Participate:
Organizations:
- Biologics and Advanced Therapy Manufacturers
- Contract Development and Manufacturing Organizations (CDMOs)
- Quality Control (QC) and Contracted Analytical Testing Laboratories
- Research & Development Organizations
- Regulatory, Public Health, and Reference Laboratories
Personnel:
- Team Leads and Analysts Mycoplasma Testing and Manufacturing
- Quality Assurance Specialists of Method Validations
- Analytical Development and Process Development Scientists
- Regulatory Affairs