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.

Objectives:

  • 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

Speaker:

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.

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