Product: HPC, Cord Blood
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Vaccines, Blood & Biologics
Applicant: SSM Cardinal Glennon Children's Medical Center
Telecon Date/Time: 18-Mar-2013 03:00 PM Initiated by FDA? Yes
Telephone Number: ------(b)(4)--------
1. Information Request
Author: BRENTON MCCRIGHT
Discussion of expiration date protocol.
FDA Participants: Brent McCright, Keith Wonnacott
Non-FDA Participants: Donna Regan, Kathy Fortune
Telecon Body: The purpose of this telecon was to discuss the acceptance criteria used to establish expiration dates for their CBUs. I said their general approach for establishing an expiration date was acceptable but their limits for judging the stability of cryopreserved units were too lenient. That instead of using (b)(4) Standard deviations from the mean of the historical data, they needed to establish limits that would be able to detect product degradation with more sensitivity. I also said that statistics could be used to analyze the data to address potential failures but in this case it did not seem appropriate to use statistics to establish acceptance limits.
Keith Wonnacott mentioned that in the CB guidance, it says that at least 70% of the TNCs need to be recovered with 70% viability after cryopreservation and reconstitution. He suggested that these criteria could be used to establish expiration dates.
SLCBB agreed that this was a reasonable approach. They wondered if they still needed to include the CD34+ cell recovery data since it is not mentioned in the CB Guidance.
I suggested that they should.
Keith Wonnacott suggested that along with new limits, SLCBB should also provide some rationale for their acceptance criteria.
SLCBB finished the conversation but saying that they would soon respond as requested by sending in an updated expiration date protocol.