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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Telecon, May 10, 2012 - HPC Cord Blood

 

RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA    Submission ID: 125391/6    Office: OCTGT
Product:
HPC (Hematopoietic Progenitor Cells), Cord Blood
Applicant:
Clinimmune Labs, University of Colorado Cord Blood Bank
Telecon Date/Time: 10-May-2012 1:00 PM        Initiated by FDA? Yes
Telephone Number: ----(b)(4)-----
Communication Categorie(s):
Product
 
Author: Yong Fan
Telecon Summary:
Product – Stability Testing Protocol
FDA PARTICIPANTS:
Ramani Sista
Yong Fan
 
NON-FDA PARTICIPANTS:
Sharon Miller
Brian freed
Michael Aubrey
Linda Tapia
Sabine Stockinger
 
Trans-BLA Group: No
 Related STNs: None
Related PMCs: None
 
Background: ClinImmume submitted stability study protocol to support the shelf- life of the product ----------------------------------(b)(4)------------------------------------------. The following acceptance criteria are not acceptable:
(b)(4) of the products achieve at lease (b)(4) post thaw by ----(b)(4)----
(b)(4) of the products achieve at least (b)(4) TNC recovery
 
Telecon Body: FDA stated that the above acceptance criteria are not acceptable because when a acceptance criteria is established for a stability study, 100 % of the products should be included. FDA further stated that although the acceptance criteria are not acceptable, the data generated for the stability study does support the 5 years shelf life. Therefore, the acceptance criteria have to be amended and submitted to FDA as supplement after the BLA is approved. The future stability study can not be initiated until FDA reviews and approves the amended protocol. The applicant agreed.