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Vaccines, Blood & Biologics

Telecon, March 9, 2012 - HPC Cord Blood


Submission Type: BLA    Submission ID: 125391/0    Office: OCTGT
Hematopoietic Progenitor Cells,Cord (HPC-C)
Clinimmune Labs
Telecon Date/Time: 09-March-2012 1:45 PM        Initiated by FDA? Yes
Telephone Number: 303 724 1307
Communication Categorie(s):
Sterility data clarifications 
Telecon Summary:
 Sterility data clarifications 
Ramani Sista
Joydeep Ghosh
Sharon Miller
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
The Sponsor emailed sterility information and the reviewer requested clarification on some points:
FDA Revised sterility SOP - proposed time for incubation
Sponsor - In processing SOP, microlab SOP
2. # pg 22 on 29 - Organisms
Why a range for some and # for some
Sp. Processed in triplicate, several different ---(b)(4)---, run a control plate a test was ran. Individual inforamtion available will be sent.
FDA - not all assays done on same day, but as CB was available
3. pg 21 -(b)(4) - no org detected Day 14. (b)(4) - day not included, that too Day 14?
Sp. Yes.
4. Pg. 19 - 1st Bacteria. Incubate without (b)(4), minimum detection time was (b)(4), when (b)(4) was added the time reduced to (b)(4), is this correct?
Sponsor. Yes.
5. What incubation time in SOP?
Sp. (b)(4)
FDA. Possible that sample did not contain bacteria.
Sp. Exactly.
FDA - --(b)(4)--, what is detection time?

Sp. See in ind. Data sheet.

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