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Vaccines, Blood & Biologics
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125391/0 Office: OCTGT
Hematopoietic Progenitor Cells,Cord (HPC-C)
Telecon Date/Time: 27-January-2012 4:00 PM Initiated by FDA? Yes
Telephone Number: -----(b)(4)------
Author: RAMANI SISTA
Product – TNC Validation
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Background: ClinImmume submitted stability data with a ----------(b)(4)------------ processing method validation. All the units used for this validation were manufactured in 2005, therefore, the study is a retrospective data analysis, not a prospective validation. FDA initiated a telecom to request a prospective ---(b)(4)--- processing validation.
Telecon Body: FDA stated that all processing procedures include the -(b)(4)- processing, should be validated prospectively. ClinImmune confirmed that they did perform a prospective validation of the -(b)(4)- processing with RBC depletion efficiency, TNC recovery, ---(b)(4)--- viability, sterility, and (b)(4) data. FDA asked ClinImmune to submit the validation data for review and ClinImmue agreed.