Telecon Comments Email, October 11, 2012 - ALLOCORD


From: Tull, Lori
Sent: Thursday, October 11, 2012 11:37 AM
To: 'Donna Regan'
Cc: McCright, Brenton
Subject: Comments for today's telecon

Hi Donna,

Brent has some comments for you in preparation for today's telecon:

1) Your validation plan proposing to statistically compare data from (b)(4) prospectively selected CBUs to PrepaCyte-CB historical data is an acceptable approach to process validation. Please define your acceptance criteria prior to data collection.
2) In addition to the statistical data comparison, you should also add (b)(4)-processing TNC viability (b)(4) as an acceptance criteria.

3) For the thaw and reconstitution validation you should set a target acceptance value for viable cell recovery of at least 70% as specified on pages 29, 30 of the Cord Blood guidance.

http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM187144.pdf

4) We acknowledge that there may be data that occasionally falls below the target acceptance value for viable cell recovery, but for validation purposes it should remain within the acceptable range defined by your historical data.

Talk to you soon,

Lori

Lori A. Tull
Team Leader
Regulatory Management Staff
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research
(301) 827-5359

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