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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Record of Telephone Conversation, March 15, 2013 - HPC, Cord Blood BLA 125432

Submission Type: BLA    Submission ID: 125432/0    Office: OCTGT
Product:HPC, Cord Blood
Applicant:LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 15-Mar-2013 11:30 AM        Initiated by FDA? Yes
Telephone Number: --------------(b)(4)---------------------------------
Communication Categorie(s):1. Information Request2. Advice
 
Author: CANDACE JARVIS
Telecon Summary:This meeting was requested by FDA to address the company's issues with the sterility validation studies.
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)
      Kimberly Benton, Ph.D., Deputy Director (CBER/OCTGT/DCGT)

Non-FDA Participants: Jill Evans, Vice President of Quality
                                      Lori Masingil (Technical Communications Manager)
  Tammy Lawson, (Validation Coordinator)
     Amy Lambert, (Manager Cellular Therapies
     Luis Hernandez
     Edward Downey
     Evan Basler
     Dr. Moureau
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:FDA requested a brief teleconference with Life South to discuss their sterility validation studies.
FDA asked if the BLA applicant was still having trouble detecting the ---(b)(4)---- within the (b)(4) time period.  The applicant stated that they are able to detect the species on day       (b)(4) in the presence of the by-product and within –(b)(4)-- for the media only positive control.  FDA asked if they were using a new lot of (b)(4), Life south stated that no, they were using the same lot.

FDA recommended that the applicant use a second species in their validation study, such as -----(b)(4)-----, as they were having problem detecting the obligate anaerobes.  The applicant stated that they have already initiated the study and will submit the data as soon as it is completed.
FDA requested the applicant to use either ------(b)(4)--------------------- to qualify their               --(b)(4)---- media lots in future and update their SOP (b)(4)-QC.2.2. The applicant agreed.

FDA asked if the company had any plans to retest if there were any sterility test failure with a positive result.  The applicant stated no as there will be no leftover by-product.  FDA requested that they also add this information to their SOP.  The applicant agreed.
The applicant concluded that they would be sending the remaining outstanding responses including the sterility validation studies in by the 18th of March, except the data from the ---(b)(4)----- study.  FDA acknowledged this point.

The call ended cordially.