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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, December 12, 2012 - HPC, Cord Blood BLA 125432

 

Product:
HPC, Cord Blood
Applicant:
LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 18-Dec-2012 11:00 AM        Initiated by FDA? Yes
Telephone Number: ------------------(b)(4)---------------------------
Communication Categorie(s):
1. Advice
 
Author: CANDACE JARVIS
Telecon Summary:
Discussion of Sterility Protocol Draft
FDA Participants: Mohammad Heidaran, Ph.D., Biologist (CBER/OCTGT/DCGT)
      Eric Dollins, Ph.D., Biologist (CBER/OCTGT/DCGT)
      Joydeep Ghosh, Ph.D., Microbiologist (CBER/OCTGT/DCGT)
      Candace Jarvis, B.S., CSO (CBER/OCTGT/RMS)
      Safa Karandish, B.S. MT (ASCP). CSO (CBER/OCTGT/DHT)
      Karoll Cortez, Ph.D., Medical Officer (CBER/OCTGT/DHT)
 
Non-FDA Participants: Jill Evans, (Vice President of Quality)
                                     Amy Lambert, (Manager Cellular Therapies)
                                     Tammy Lawson, (Validation Coordinator)
 Jessica Drouillard
                                     Evan Basler
 Arlene Dowd
                                     Luis Hernandez
                                     Matt Audette
                                     Tamara Cannady
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
FDA requested a brief teleconference with Life South to discuss their proposed sterility protocol draft sent via email on December 14, 2012.
Summary of Discussed topics:
  1. FDA reminded the sponsor to submit a copy of the revised sterility test SOP (based on their future assay validation results) along with the assay validation data as an amendment and the sponsor agreed.
  2. FDA recommended the following corrections and additions to the draft validation protocol:
a.      Correct the inoculum size for the previous validation studies – these studies were done with -------(b)(4)------------- product plus (b)(4) of bacterial inoculum.
b.     Specify that the Cord Blood samples for the validation study would be obtained from donor mothers not on interpartum antibiotics.
c.      Include a summary of how the samples would be processed.
d.     Include a summary of how the (b)(4) bottles would be inoculated – inoculation of (plasma + RBC) vs. individual inoculation of plasma and RBC. FDA recommended that the sponsor contact the manufacturer to check how many times the (b)(4) bottle septum could be punctured without compromising the seal (as it might be a problem for the anaerobic bottles).
e.      Specify at which point the test microorganisms would be added to the sample.
f.      In lieu of directly testing the robustness of the sterility assay: specify how the sponsor would monitor the temperature of the incubator and room and describe the action plan incase of a failure.
g.     State the temperature range for the incubator as ----(b)(4)--- instead of ---(b)(4)- – if possible reduce the tolerance to (b)(4).
h.     Specify that the less than (b)(4) inoculum is per bottle
i.       Submit the data from all triplicate plate count assays for determining the number of (b)(4).
j.       Acceptance Criteria: ---------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------. However, the sponsor should not pull any sample with a negative reading for growth before -(b)(4)- from the (b)(4) detection/incubation machine.
k.     FDA is OK with sample pooling for the validation study but the sponsor should specify the pooling and storage criteria – the sponsor said that they were planning to pool the processed by-products and within a maximum of ---(b)(4)- from the time of collection. FDA responded that those are acceptable.
l.       FDA reminded the sponsor that although they have no problem sponsor pulling the different lots of by-products for the assay validation, there is a potential problem if one of those lots is contaminated – the whole study would have to be repeated. The sponsor acknowledged the magnitude and suggested that they could do the validation studies in a staggered fashion but they are concerned about the non-uniformity of the test matrix. FDA responded that it would be OK for the sponsor using different lots of cord blood by products for the different test organisms.
m.   Timeline of data submission: The sponsor could not specify a time line other than stating that they would try their best to finish and submit the data as soon as possible.
n.     The sponsor stated that they were waiting for the facility isolate determination before starting the validation. FDA stated that it is not necessary to wait as they now have a more or less acceptable validation plan - the sponsor agreed. The sponsor also asked if FDA would take a look at a revised draft validation plan incorporating all the FDA recommendations discussed above – the FDA responded that they would be happy to take a look.
The call ended cordially.