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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request Email , April 7, 2011 - Bivigam

 

To: Matthew Vaughn
Biotest Pharmaceuticals Corporation

This is regarding your BLA submission STN 125389/0 for Immune Globulin Intravenous (Human), submitted to the Agency on November 3, 2010.  FDA continues with the review of the referenced submission and requests BPC to provide the following information.     
 
1.     The validation and characterization of your manufacturing process is not complete in that:
a.      -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. 
 
b.     -------------------------------------------------------------------------------------------------------------------------------------(b)(4)----------------------------------------------------------------.
 
c.      ---------------------------------------------------------------(b)(4)----------------------------------------------------------------.
 
d.     -------------------------------------------------------------------------------------------------------------------------------------(b)(4)-----------------------------------------------------------------------------------------------------------------------.
 
e.      -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. 
 
f.      -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. 
 
2.     Please describe how you set the bioburden limits.
 
3.     Please provide DEV3234 mentioned in report FR-2009-13.
4.     Please provide a table of all the deviations, including those that occurred in the QA laboratory. Please also include a brief description and the associated validation report number, if applicable.
 
5.     Please provide an explanation for -----(b)(4)----- following nanofiltration ---(b)(4)----.
 
6.     Please provide the executed batch record for Lot --(b)(4)--.
 
7.     Please provide the SOPs for the preparation of buffers used during ----------------(b)(4)----------------.
 
8.     Please provide an SOP and raw test results for the plasmin/plasminogen and albumin tests.
 
Please submit a response to this request as an amendment to the file by May 9, 2011.
Thank you.
Pratibha Rana