《Anders Vinther Leptospira PDA WCC 19 Jul 2016》.ppt

Acknowledgements (and many more…) Harry Lam Robert Kiss Vickie Frydenlund Patricia Lufburrow Dave Peers Joseph Chen Kathey Hanley Jesse Bergevin Gordon Walker Jun Luo Todd Battistoni Batu Berkok Kevin McCarthy Dana Thompson Vaishali Shah Joe Runner Aimee Lehman Keith White Mark Pedersen Kevin Johnson Rich Clements Meliana Ratna Mark Smith Robb Shawley Tom Stapp Domenic Matthews Robel Tezare David Traub Marcia Coyne Louisa Gingery Peter Hawkins Ivar Kljavin Mireille Methlin Holger Kavermann Tobias Manigold Vijay Palsania Emma Ramnarine Mark Skoog Friedrich von Wintzingerode Nathan McKnight Adeyma Arroyo Bold indicates presentation preparation * * Want industry and regulators to be aware of this finding that has potential impact across the industry. Underlying message from House TV show is relevant to this event and investigation * Or, let’s not necessarily throw out all the useful elements of the pre-electronic age. In this case, as we will show, having humans evaluate the state of a mammalian cell culture process from the standpoint of presence of non-host cells still adds value to the process. * * Standard contamination response - testing in industry standard microbiology media such as TSA, SDA, etc. with no growth * Standard contamination response - testing in industry standard microbiology media such as TSA, SDA, etc. with no growth Talking points: Thaw 1 and 2 were from first event contamination. Between 1 and 100 Lepto/mL very early in the seed train accounts for the timing of the observed contaminations by MVE. This scenario is consistent with the media geneaology in which a common lot of spinner media was used in both thaw 1 and 2. Thaw 3 was from the second contamination event. The observation here was much later in the “lifetime” of the thaw, and points toward a contaminant introduction much later after thaw, more likely beyond the spinner passaging stage and at the 20L bioreactor stage. * * * * * * * Product – will show data on pH and filtration