Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

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.

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

THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender immediately by e-mail or phone.


Page Last Updated: 06/26/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English