Topics to consider for method validation and conversation with authorities.
Validation of release methods and approval by authorities can sometimes be long lasting and with a lot of misunderstandings. Sharing experience from already accepted methods can help facilitating upcoming approvals.
This webinar shows how the FAQs asked by authorities have been addressed during validation of mycoplasma testing within Roche Pharma, the experiments that have been done, and the results which have been presented to the FDA.
The following points have been addressed:
• Does the PCR sample represent the same homogeneity of larger cell culture sample ?
• What about the viability of mycoplasma stocks (freeze/thaw)?
• Comparability of cell culture and PCR methods
• Risk assessment of MycoTOOL kit to detect other mycoplasma
• Importance of GC/CFU ratios
Listeners who are already familiar with the topic of Pharma Release testing, and who wish to learn more about the validation of mycoplasma testing as release test should register for this webinar.
Presented by
Dr. Inga Böll,
Director International Product Management Custom Biotech – Bio-Manufacturing
Inga studied Biochemistry at the University of Hannover and obtained her PhD in 2001. In 2002, she joined Roche Applied Science R&D. After several years in Customer Support, next generation sequencing, and an assignment in Shanghai, China, she joined Custom Biotech Marketing in 2010. She is responsible for the Pharma QC Portfolio as well as for Cell Therapy.
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Key Learning Objectives
- Learn more about mycoplasma testing using MycoTOOL.
- Learn how to validate mycoplasma testing asPharma release test.
- Learn how to address questions from authorities.
- Learn what is important to take into account when working with mycoplasma.
Audience
- Pharma QC Managers
- Microbiology
- Compliance
- Engineering
- Manufacturing
- QA/QC
- Regulatory Affairs
- Research and Development
- Validation
- Release Testing
- Scientists
- Technicians