Vaccines, Blood & Biologics
Record of Telephone Conversation, November 8, 2012 - HPC, Cord Blood BLA 125432
Submission Type: BLA Submission ID: 125432/0 Office: OCTGT
HPC, Cord Blood
LifeSouth Community Blood Centers, Inc.
Telecon Date/Time: 08-Nov-2012 12:00 AM Initiated by FDA? Yes
Author: MOHAMMED HEIDARAN
Advice was given about the batch record
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
I spoke to Jill Evan VP of Quality at LifeSouth about the batch record. I emphasized the importance of including (1) all critical steps in the batch record; (2) all calculations for addition of HES or DMSO for example to the cord blood during the processing steps; and (3) Acceptance criteria for all critical process parameters such as a) time of cord blood collection to cryopreservation; b) time of DMSO addition to the processed cord blood to cryopreservation; c) predetermined time and temperature for cryopreservation (freezing acceptance criteria) etc. The sponsor agreed to send a revised batch record for further discussion.