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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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CMC Related Information Request, November 8, 2011 - Gintuit

  

  1. Regarding the tests that are performed to qualify a Master Cell Bank and Working Cell Bank Qualification, please provide the following information.
 
    1. A list of tests/assays that are performed as a part of master cell bank qualification of HEPs, HDFs
 
    1. A list of tests/assays that are performed as a part of working cell bank qualification of HEPs, HDFs
 
    1. Per the telecon on 11/8/11 between FDA and OI, the VEGF quantification assay is considered part of ----b(4)---------------------- release testing and will be submitted to the FDA as part of cell strain qualification. Please verify. Note in the BLA, the VEGF quantification assay is presented as a Working Cell Bank (WCB) release test. See Table Table 3.2.S.2.3.3-15 (Overview of Working Cell Bank Release Testing) and the assay description in section 3.2.S.2.3.3.3 (Working Cell Bank Testing) (page 47-50 of 62).  Please comment.
 
    1. Please verify isoenzyme analysis is performed for working cell bank release testing. This assay is not included in Table 3 (Working Cell Bank Testing) of Organogenesis’ briefing document. Additionally, isoenzyme analysis is not included in Table 3.2.S.2.3.3-18 of the BLA but is described in the text (page 58/69, 3.2.S.2.3- Control of Materials- General Testing of Cell Banks; performed by ----b(4)-------
                                                                                                                       
  1. Regarding the tests that are performed to support a new cell strain, please provide the following information.
 
    1. A list of all tests/assays that will be submitted to the FDA for review to support the safety and comparability of new cell strains.
 
    1. A list of all tests/assays that are used for comparability testing but are not included in the data submitted to FDA to qualify new cell strains (e.g. identity testing of WCB).
 
    1. Per the telecon on 11/8/11 between FDA and OI, it was stated that tests exclusive to the Working Cell Bank (WCB) are not included in the cell strain qualification data to be submitted to the FDA; however, it was also stated that release testing data from one WCB will included. Please clarify. 
 


 

  1. Please clarify at which passage number the MCB cells are tested for tumorigenicity. There are inconsistencies in the BLA submission.
 
    • In the text (page 44/69, 3.2.S.2.3- Control of Materials- General Testing of Cell Banks), it states:  
      ---b(4)----------------------------------------- ------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
    • However, in Table 3.2.S.2.3.3-16, it states:
      -----b(4)--- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------