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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Teleconference, August 20, 2010 - Corifact

From:                     O'Lone, Martha (CBER)
Sent:                      Friday, August 20, 2010 4:06 PM
To:                         'david.desris@cslbehring.com'; 'paulhartmann@cslbehring.com'
Cc:                         Schmidt, Jennifer
Subject:                 Questions from Teleconference

Dear David and Paul,

 Thanks for talking with us today concerning our questions for the Factor XIII BLA.  I am including our questions for follow-up;
 

  1. Please state whether the IND lots -----(b)(4)----, etc in this submission were manufactured according to GMP in US licensed rooms, using US dedicated columns?
  2. Is there any difference between your IND process and the GMP process that were used for the conformance lots?
  3. Do you plan to market the IND Process Validation lots?  Will you be marketing IND process lots that were filled subsequent to these process validation lots?
  4. In the information about your plans for a subsequent PAS that will include the three conformance lots made with a ------------------(b)(4)---------------------, you stated that you will use a ---------------(b)(4)--------------. Please clarify if the filling/lyophilization suite  ------(b)(4)------------------- that will be included in the PAS has been used for any other US licensed product or European product.   Please identify the equipment and Room numbers.

Thanks,
Martha O’Lone and Jennifer Schmidt

   
CAPT Martha O'Lone, BSN, R.N.
Director Regulatory Review  
FDA/CBER/DMPQ
301-827- 3031