Rapid detection of Mycoplasma is essential for autologous cell therapy products with short shelf lives. Developing, validating, and transferring a rapid Mycoplasma test based on real-time PCR technology presented many unique challenges. Application of a risk-based approach during test development mitigated most issues prior to validation. Proactively removing these obstacles facilitated a successful implementation supported by regulators for implementation as a routine lot-release test. In this webinar we'll discuss.
- Define challenges associated with testing autologous cell therapy products
- Mitigate risks unique to testing for Mycoplasma
- Identify method selection criteria to facilitate successful validation
- Describe advantages and limitations of an implemented rapid Mycoplasma test
John Duguid is currently the Senior Director of Research and Development at Vericel Corporation. At the time of this presentation (2015) he was the Principal Process/Analytical Scientist at Aastrom Biosciences.
Fill in the form to view the free on-demand webinar.