
Record of Telephone Conversation, February 26, 2013 - HPC, Cord Blood BLA 125432

 

 
Product: HPC, Cord Blood
Applicant: LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 26-Feb-2013 02:00 PM        Initiated by FDA? Yes
Telephone Number:  ----------(b)(4)------------------------------
Telephone Number: 
Communication Categorie(s): 1. Information Request 2. Advice
 
Author: CANDACE JARVIS
Telecon Summary: FDA requested this teleconference to discuss Life SOuth's Sterility Protocol
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)

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
  Matt Audette
  Evan Basler
  Arlene Dowd

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.  
1. The sponsor acknowledged that they have trouble growing the anaerobes in the          ---(b)(4)----.
2.  They are strictly following the manufacturers guideline for sample inoculation so it is unlikely that the sample inoculation could compromise the media.
3. FDA suggested the ----(b)(4)---------- media as an alternative  the sponsor asked if they need to repeat validation if they change the media. FDA said yes.
4. FDA suggested using Bacteroides vulgatus if the sponsor have problem growing    --(b)(4)--. The sponsor said they dont want to change anything this late as they have trouble growing the same before.
5. The sponsor is expecting the new batch of ----(b)(4)------------ to grow in the presence of the by-product but it might take more than --(b)(4)- to get detected. When asked if that would be acceptable to FDA, we told them to submit the data for an FDA-internal discussion.
6. FDA suggested the sponsor to use a strict anaerobe like Clostridium or Bacteroides (instead of (b)(4)) to qualify their anaerobic media lots in future.

 
