


CMC Information Request, September 12, 2011 - Gintuit



 
 

Please direct FDA to the specific section in which the information can be found. 
If the requested information is not contained in the BLA, please provide the 
following:

 
  A detailed summary of the current understanding of the function of the viable 
  cells as a part of the final mature construct. Please include in your summary 
  any data from Apligraf and a comprehensive search of literature references 
  regarding Apligraf and other related products (i.e., wound healing products 
  that contains viable cells).

 
  A detailed written explanation for the changes observed in the karyology 
  (cytogenetic) testing results observed pre- and post-year 2000 for both MCBs.  
      
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  While we take this to be a welcome development, we would like to understand 
  what led to these changes and what other potential impacts on product quality 
  may have occurred. Please verify in your response that product testing had not 
  changed (test methods, reagents, instruments, etc.). Additionally, please 
  provide from relevant guidance and/or current literature the number of 
  expected abnormalities for cultured diploid cells per passage for each 
  parameter and compare these values to your specifications and values obtained 
  during previous manufacture.
 

 