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Vaccines, Blood & Biologics
From: Tull, Lori
Sent: Thursday, December 22, 2011 11:16 AM
To: 'Donna Regan'
Subject: FDA request for information
Our latest CMC requests for information are listed below.
To facilitate the review process, we would like to request the following information.
1. Additional information concerning the cord blood processing and lot release testing SOPs used at the Kansas City, St. Luke (SLCI) manufacturing facility is needed.
a. Please identify the contractor SLCI uses for hemoglobin and HLA testing.
b. Please supply the SLCI SOP for viable nucleated cell testing and the colony forming assay.
c. Please specify the cord blood manufacturing processes where the SLCI SOPs are identical to St. Louis (SLCBB) SOPs. Please refer to specific SLCBB SOPs that have been submitted.
2. Your proposed potency assay will enumerate Total Nucleated Cells (TNC) using the ------------------------(b)(4)------------------------------. You have provided data intended to support validation that includes enumeration of some individual cell subsets without clear comprehensive totals of nucleated cell numbers. Please clarify your definition of TNC used for product release and provide all relevant SOPs (SLCI and SLCBB) for your TNC enumeration.
3. For both SLCI and SLCBB sites, please clarify how you decide whether to use ----------(b)(4)---------- for viable nucleated cell testing. Please provide viability (both methods) validation data for both SLCI and SLCBB sites.
4. Please provide infectious disease validation data for the Community Blood Center.
5. Please provide validation data for the HLA typing and hemoglobin analyses which are performed by outside contractors. Supporting information should include proficiency test results, methods used, and contractor accreditations/certifications.
As we discussed, we would like to schedule a telecon to discuss our requests with you. The times we have available (in EST) are:
Wednesday, 1/4 at 10 or 11 am
Thursday, 1/5 at 11 am
Friday, 1/6 at 3pm.
Please let me know if any of these times would work for your group.
Lori A. Tull, RAC
Regulatory Project Manager
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research
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