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)------------------------------
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)
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 manufacturer’s 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 don’t 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.