MycoTOOL® Mycoplasma PCR – Regulatory Considerations for FDA Acceptance

Please view the webinar recording below and learn about Roche Pharmaceutical’s journey to regulatory acceptance of the MycoTOOL® PCR Mycoplasma Detection for release of some of their commercial biopharmaceutical products. The MycoTOOL® test is a nucleic acid based (PCR) rapid mycoplasma test produced by Roche and distributed through Lonza.

In the webinar we discuss:

  • Regulatory considerations for validation of an alternative, PCR-based mycoplasma detection method
  • Advantages of implementing a rapid release test  in the Pharma – QC environment


This webinar was held on 11 June 2013 by Sean Fuerst, Scientific Support Specialist at Lonza Pharma&Biotech – Bioscience Solutions., and: 


Dr. Holger Kavermann
Senior Manager Quality Control       
Micro and Cell Biology
Roche Pharma Biotech 

Dr. Inga Boell
Director International Product Management
Custom Biotech - Bio-Manufacturing
Roche Custom Biotech

Please also visit our webinar archive  to view the recordings of further recently held webinars. To learn more about upcoming Lonza webinars, please go to