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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Related to the Cell Banking System, August 19, 2011 - Gintuit

 

The following information could not be located. 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 copy of the donor screening questionnaire
 
  1. A copy of the SOP listed below [SOP ID] and accompanying validation report, including a validation summary table, for:
    1. Percutaneous Absorption [-b(4)- SP630015], performed by ----b(4)-----------------------------
    2. Cytokine Profile [QCP-119]
    3. In vivo bioequivalence test methods [QCP 153, QCP 154, QCP 155, QCP 156, and QC-OPER-00491]
    4. Isozyme and Cytogenetic Analysis [-b(4)--CCP.10], performed by ---b(4)------------------------------------------------------------
                                                               i.      Please clarify if both isozyme and cytogenetic analysis are performed only on the MCBs or are also performed on the WCBs.
                                                             ii.      Please clarify if isoenzyme analysis will be performed on the WCB by –b(4)---------- (as described in Section 3.2.S.2.3, page 37/48 but not included in Table 3.2.S.2.3.3-10) or by ---b(4)---------------------------------------------CCP.10] per above.
    1. Senescence [MBR-050 (HEPs); MBR-051 (HDFs)]
    2. Collagen Biosynthesis [QCP-129]
    3. Involucrin Content [QCP-068]
 
When providing the method validation summary tables, please provide the data in terms of the appropriate ICH Q2(R1) validation parameter (e.g. specificity, linearity, range, accuracy, precision, etc.), acceptance criteria, and summary of results. Several of the method validation summary tables which have already been submitted to the BLA have used this format.
 
  1. A copy of the SOP listed below [SOP ID] and accompanying validation report (validation summary table has already been provided) for:
    1. Mitochondrial Tetrazolium Testing (MTT) [QCP-112]
    2. Cell Purity Testing Utilizing Flow Cytometric Techniques [QC-OPER-00569]
      1. Including original validation and re-validation performed by –b(4)----------------------------------
      2. Please provide the data for the HDFs. Although the narrative description states this assay will be used as a purity assay for WCB for HDFs and HEPs (Section 3.2.S.2.3), only data for HEPs is provided (e.g. Tables 3.2.S.2.3.3-5 and Table 3.2.S.2.3.3-6). It is unclear if the assay has been qualified & validated for the HDFs.
    1. VEGF Quantitation [QCP-173]

       
  1. We note that you have provided a response to our previous request to provide the validation reports of analytical procedures for the final product release specifications outlines in Table 3.2.P.5.1.1-1 of the BLA submission:
    1. QCP-072-Mycoplasma
    2. QCP-002 Sterility
    3. QCP-053 Visual Inspection
 
We request you provide method validation summary tables in terms of the appropriate ICH Q2(R1) validation parameter (e.g. specificity, linearity, range, accuracy, precision, etc.), acceptance criteria, and summary of results for each final product release specification listed in Table 3.2.P.5.1.1-1 of the BLA submission.
 
The format and content should be similar to the data tables you have provided for SOPs QC-OPER-00547 (Morphological Evaluation) in Table 3.2.P.5.3-3 and QCP-002 (BacT/ALERT microbial detection) in Table 3.2.P.5.3-5.