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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.
 
Discussion:
 
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.
 
Attendees:
 
FDA:
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