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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon, December 2, 2011 - 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: 02-December-2011 11:00 AM        Initiated by FDA? Yes
Telephone Number: -----(b)(4)-----
Communication Categorie(s):
1. Sterility
 
Author: RAMANI SISTA
Telecon Summary:
Sterility Discussion
FDA PARTICIPANTS:
Ramani Sista
Yong Fan
Joydeep Ghosh
Kim Benton
 
NON-FDA PARTICIPANTS:
Brian Freed
Sabine Stockinger
Linda Tapia
Michael Aubrey
Sharon Miller
-----(b)(4)------
 
Trans-BLA Group: No
 Related STNs: None
Related PMCs: None
 
Telecon Body:
Following introductions, FDA stated that they needed some clarifications regarding their processing:
 
1.                  FDA asked the Sponsor if plasma is added to the RBCs. The Sponsor stated that  ------------------------------(b)(4)-----------------------------------------. FDA stated that they have to specify in the BLA application what surrogate they want to use –       --------------------(b)(4)-------------------- and validate acordingly.
 
2.                  FDA asked the Sponsor the centrifugation speed they use. The Sponsor stated that they use (b)(4) to precipitate the RBC fraction. 
 
FDA stated that if they are planning to use the ---(b)(4)--- surrogate they don’t need to demonstrate the effect of --(b)(4)-- and centrifugation on the distribution of microorganisms in the surrogate sample.  
 

The Sponsor requested additional clarification regarding points 7, 8 and 9 related to sterility information, requested in the AI letter dated October 28, 2011. FDA provided adequate clarification.