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Vaccines, Blood & Biologics

Teleconference Regarding Data - Ducord


RE: Teleconference regarding Data from Duke (b)(4) Pilot Study
Time: 4:30pm
Attendees can use the following number for the call:
Number: -----(b)(4)------
Passcode: ---(b)(4)---
Duke University (Sponsor) Regarding missing data that demonstrate that the Hespan and Centrifugation do not significantly reduce the number of contaminating microorganisms in the post-process (b)(4) and (b)(4) fractions (with respect to the respective HPC-C fraction).  FDA is verifying that this study is being done before sponsor move to the repeat validation.
1.         The sponsor has clarified that they tested the effect of Hespan and centrifugation on the distribution of microorganisms in the --(b)(4)-- sample.  However, they were not able to keep the initial inoculum under ----------------------(b)(4)---------------------------  as proposed earlier.  The experiment on ------(b)(4)------ is pending and all data will be formally submitted with the Phase II validation data.
2.         FDA recommended that they change their "target" inoculum level to ------------------(b)(4)-----------------------  for the Phase II repeat studies to safely stay under the required regulatory limit of ----------(b)(4)----------.
3.         FDA also recommended that they verify their dilution series and the actual inoculum level per bottle (by plate assay) in triplicate.
Joydeep Ghosh, CMC Reviewer
Mark Davidson, RPM
Duke University:
Amanda Parrish- Associate Director, Regulatory Affairs; Duke Translational Medicine Institute/Duke University
Tracy Gentry- GMP Lab Director; Robertson Clinical and Translation Cell Therapy Program
Rebecca Durham- Project Leader; Robertson Clinical & Translational Cell Therapy Program-CT2- DTRI


Page Last Updated: 09/24/2013
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