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Vaccines, Blood & Biologics

Telecon, December 6, 2011- HPC Cord Blood


Submission Type: BLA    Submission ID: 125391/0    Office: OCTGT
Hematopoietic Progenitor Cells,Cord (HPC-C)
Clinimmune Labs
Telecon Date/Time: 06-December-2011 4:00 PM        Initiated by FDA? Yes
Telephone Number: -----(b)(4)----
Communication Categorie(s):
Sterility Issues
Telecon Summary:
Sterility Issues – Data Table by Dr. Ghosh
Ramani Sista
Yong Fan
Joydeep Ghosh
Kim Benton
Brian Freed
Sabine Stockinger
Linda Tapia
Michael Aubrey
Sharon Miller
Deborah Havens (Supervisor, Microbiology Lab)
Trans-BLA Group: No
 Related STNs: None
Related PMCs: None
Telecon Body:
FDA asked the Sponsor to outline their current procedure for sterility testing and validation. The Sponsor stated that for their post processing procedure, they use -----------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------. The bottles are incubated for (b)(4) in a (b)(4) machine. 

FDA stated that the Sponsor should also add their data to the attached table (Appendix 1), sent via email earlier in the day (12/06/2011) for the respective organisms and send the data to the BLA file. FDA also stated that the organisms should be calculated in numbers and not as cfu/ml. When adding the ------------------------(b)(4)-------------------, FDA advised the Sponsor to measure the exact amount being added. The Sponsor asked if they could substitute any of the micro-organisms outline in the list send by FDA? FDA stated that substitution can be made only if the Sponsor can show that the organism is a strict aerobe. FDA asked the Sponsor regarding the growth of mold – -----(b)(4)----. The Sponsor stated that temperature is an issue to promote growth of ----(b)(4)---, FDA asked the Sponsor to provide all information regarding the Sponsor’s current procedure to test mold growth.

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