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Vaccines, Blood & Biologics

Information Request Email, March 2, 2012 - ALLOCORD


From:        Tull, Lori
Sent:          Friday, March 02, 2012 11:46 AM
To:             'Donna Regan'
Cc:             Ghosh, Joydeep; McCright, Brenton
Subject:     FDA request for information re: sterility
Hi Donna,
As discussed in this morning's telecon, below are our requests for information regarding sterility validation.

1.     We note two sterility testing facilities for the Saint Louis Cord Blood Bank (SLCBB)
a.      ------------------(b)(4)------------------- (ref: Table 1 of STN 125413/0, November 29, 2011) and
b.     SLCBB in-house facility (ref: page 130 of STN 125413/0, November 29, 2011)
Which facility will be used to test the licensed product? Which one was used during the validation of the SLCBB sterility test method?
2.   The sterility test SOP/validation you provided (ref: STN 125413\0\2) for the Saint Luke’s Cancer Institute (SLCI) is not specific for testing the sterility of the HPC-C product. It also differs from the SLCBB method with respect to the
a.      Used media (-------------------(b)(4)----------------------; only SLCI uses the --------(b)(4)----------- and it is not clear why),
b.     Test sample used during validation ----------------------------(b)(4)-----------------------------
c.      Model of instrument ----------------(b)(4)--------------------.
Please submit the HPC-C-specific Sterility test-SOP for SLCI (ideally this should be identical to the SLCBB), indicate the minimum incubation time for negative samples (on SLCBB and SLCI SOPs), validate the SLCI method using a validation plan similar to the SLCBB method and submit the data for our review.
3.   Please submit the following information on the SLCBB sterility test method validation as soon as possible:
a.      A summary of initial and operational qualification reports and data and conclusion from the Phase I of the Assay Validation (ref: page 132 of STN 125413/0, November 29, 2011).
b.     Phase II of the Assay Validation, Table 52 (ref: page 134 of STN 125413/0, November 29, 2011) - all respective raw data (from duplicate samples) using the template table as proposed in Appendix W (ref: Table 3, page 5 of Appendix W of STN 125413/0, November 29, 2011).
c.      Phase II of the Assay Validation, Table 52 (ref: page 134 of STN 125413/0, November 29, 2011) - data on --------------(b)(4)---------------.
d.     We note that you do not have a mold (e.g. Aspergillus niger) in your test panel – please validate your sterility assay using a mold.
e.      Data demonstrating assay ruggedness and robustness (ref: page 134 of STN 125413/0, November 29, 2011). Also, for this part of assay validation you need to include a mold and ------------(b)(4)------------- in your test panel.
4.     We note that you are testing --------------------------------------------(b)(4)----------------------------- for your sterility assay. We are concerned that if the initial bio-burden is low you may not be able to capture the contaminants by using just ---------(b)(4)---------- because
a.      The majority ----------(b)(4)------------ consists of sterile CPD Anti-coagulant and Prepacyte reagent and
b.     The ---(b)(4)-- centrifugation at -(b)(4)- during processing could remove a large number contaminating microorganisms from the (b)(4) fraction [see -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------------------------------------------------------------.
Please provide data demonstrating the efficacy of -----------(b)(4)------------- under low bioburden conditions (for example – less than 100 CFU per collection and processing). Have you considered using the rouleauxed RBC fraction as an alternative?
5.   We note that although the anaerobes and facultative anaerobes are the most frequent contaminants of your HPC-C product (ref: Table 21, page 91 of STN 125413/0, November 29, 2011) you are not testing the final HPC-C product under an ---(b)(4)--- condition - please clarify why?
6.   We note that you have a false-positive category (ref: page 131 of STN 125413/0, November 29, 2011) for your sterility test results. Do you include the false-positive samples in your releasable inventory? Do you retest a sterility-positive cord blood unit if you find your sterility test is invalid? If yes, please submit details for the retesting procedure.
Best Regards,
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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