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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:

 
  A copy of the donor screening questionnaire

 
  A copy of the SOP listed below [SOP ID] and accompanying validation report, 
  including a validation summary table, for:Percutaneous Absorption [-b(4)- 
    SP630015], performed by ----b(4)-----------------------------
    Cytokine Profile [QCP-119]
    In vivo bioequivalence test methods [QCP 153, QCP 154, QCP 155, QCP 156, and 
    QC-OPER-00491]
    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.
    Senescence [MBR-050 (HEPs); MBR-051 (HDFs)]
    Collagen Biosynthesis [QCP-129]
    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.

 
  A copy of the SOP listed below [SOP ID] and accompanying validation report 
  (validation summary table has already been provided) for:Mitochondrial 
    Tetrazolium Testing (MTT) [QCP-112]
    Cell Purity Testing Utilizing Flow Cytometric Techniques [QC-OPER-00569] 
      Including original validation and re-validation performed by 
      –b(4)----------------------------------
      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.


    VEGF Quantitation [QCP-173]

     
  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:QCP-072-Mycoplasma
    QCP-002 Sterility
    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.
 

   