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Vaccines, Blood & Biologics

Telecon, May 10, 2012 - HPC Cord Blood


Submission Type: BLA    Submission ID: 125391/6    Office: OCTGT
HPC (Hematopoietic Progenitor Cells), Cord Blood
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):
Author: Yong Fan
Telecon Summary:
Product – Stability Testing Protocol
Ramani Sista
Yong Fan
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.

Page Last Updated: 06/21/2012
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