This presentation aims to show how Zoetis has validated the MycoSeq kit for the release of animal products They confirmed the limit of detection at 10 CFU/mL and good repeatability and intermediate precision of the qualitative mycoplasma qrt-PCR method in presence of these products.
For direct PCR performed on a vaccine, a background amplification is sometimes observed inducing a signal suggesting a positive result for mycoplasmas. Several experiments showed that this is not due to the presence of mycoplasmas. Nevertheless this induces from time to time a Cq below the cut off when performing a direct extraction. In these cases, an enrichment step is performed for confirmation. Zoetis validated this method following VICH guidelines with no major concern coming from regulatory authorities.
(Original Webcast: July 11, 2018 at 10 am EDT)
About the presenters
Lievyns Sébastien
Scientist, Analytical Lab Sciences, Zoetis Inc.
Lievyns Sébastien joined the analytical group of Zoetis in 2012 after working for more than 3 years at UCL (Louvain-La-Neuve, BE) supporting research in the area of molecular biology and biochemistry. With a Bachelor focused in Biotechnologies and Agro-industries (HELHa ISC, Fleurus, BE; 2008) Sébastien has expanded his molecular biology expertise working on the development and validation of Real Time PCR based assays. Occupying a Scientist position within the Analytical Sciences group, he worked extensively on the analytical validation of the Mycoplasma PCR assay for veterinary products release.
Anne Thomas, DVM
Senior Principal Scientist, Analytical Lab Sciences, Zoetis Inc.
Anne Thomas is a DVM by training (ULg, Liége, BE; 1997). She first performed research on canine-feline helicobacteria and later on mycoplasmas (epidemiology, virulence in in vitro models) to obtain a PhD in Veterinary Sciences (ULg, Liége, BE). Before joining Pfizer Animal Health in 2006, she was a PostDoc working in the field of innate immunity and genetics (ULg, Liége, BE). At Pfizer Animal Health, Anne Thomas was first responsible for the Biological Quality Control Labs (Immunology, Bacteriology, Virology) of the vaccines manufacturing site. In 2011. She moved to the Research and Development department of Zoetis (previously Pfizer Animal Health) where she is Senior Principal Scientist in the Analytical Sciences group focusing on biologicals.
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