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Vaccines, Blood & Biologics

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:
  1. 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).
  1. A detailed written explanation for the changes observed in the karyology (cytogenetic) testing results observed pre- and post-year 2000 for both MCBs.      -----b(4)----------------------------------------------------------------------------------------------------------------------------------------. 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.

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