Information Request Email, March 16, 2012 - ALLOCORD

 
From:        Tull, Lori
Sent:          Friday, March 16, 2012 12:58 PM
To:             'Donna Regan'
Subject:     CMC questions for you
 
Hi Donna,
 
Brent McCright asked me to forward these CMC questions to you. He said if you want to discuss them we can set up a telecon.
 
Please describe how the CBUs are stored at the processing sites prior to processing?
 
How many CBUs can be processed simultaneously and how many can be processed in one day?
 
The option of using a sterile ready-to-use -------------------------------------------------------------(b)(4)-------------------------------------------------- is mentioned in your SOP. How do you decide when to use this instead of the ----(b)(4)----- on-site?
 
Please describe how the CBUs are transferred into N2 tanks, how their storage location is chosen, and how the locations of the CBU cassettes are entered into the database and tracked.
 
Please describe in detail the database used to record lot release results and track CBU distribution.
 
A shipping export SOP, Export Procedure – SE.02.07 is referenced in the list of SOPs, but we could not find it your submission. Please submit it. 
 
There are (b)(4) segments formed at the time of cryopreservation. (b)(4) is used for confirmatory testing, what is done with the other (b)(4)? Is one retained as a retention sample?
 
 
Best Regards,
Lori
 
Lori A. Tull, RAC
Regulatory Project Manager
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research
(301) 827-5359
 
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