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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon, January 13, 2012 - HPC Cord Blood

 

RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA    Submission ID: 125391/0    Office: OCTGT
Product:
Hematopoietic Progenitor Cells,Cord (HPC-C)
Applicant:
Clinimmune Labs
Telecon Date/Time: 13-January-2012 1:00 PM        Initiated by FDA? Yes
Telephone Number: -----(b)(4)-----
Communication Categorie(s):
CMC - Sterility Issues
 
Author: RAMANI SISTA
Telecon Summary:
Sterility Issues
FDA PARTICIPANTS:
Ramani Sista
Joydeep Ghosh
 
NON-FDA PARTICIPANTS:
Brian Freed
Sabine Stockinger
Linda Tapia
Michael Aubrey
Deborah Havens (Supervisor, Microbiology Lab)
 
Trans-BLA Group: No
 Related STNs: None
Related PMCs: None
 
Telecon Body:
Following introductions, Dr. Ghosh stated that this telecom was to further discuss the sterility validation issues, outlined in previous calls.
 
Regarding validation for robustness, FDA stated that since using a (b)(4) temperature may increase the minimum time of detection, the Sponsor may provide the following information in writing in lieu of conducting the test at -(b)(4)-. FDA asked the Sponsor to provide the following:
 
  • Plan of action in the event of machine failure
  • Temperature failure
 
FDA recommended the Sponsor to summarize their procedures in detail at -(b)(4)- and submit to application. 
 
Regarding ruggedness, FDA recommended the Sponsor to use (b)(4) lots of media at (b)(4) in triplicate for the (b)(4) microorganisms listed in the table of the word document provided to the Sponsor earlier.