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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Information Request, February 8, 2012 - Gintuit

 

Additional information to be included to the response to FDA Information Request from January 26, 2012 Telecon
 
 
Bovine Pituitary Extract (BPE)
 
We note that –b(4)--- sources for bovine pituitary extract (BPE) are included in the Quality Material Specifications (QMS):
 
[                                         b(4)                                                     ]
 
  1. In BLA section 3.2.S.2.3.1.2 (Manufacture of Bovine Pituitary Extract), it states that pituitary glands from cattle sourced from –b(4)------- “will be used in the         --b(4)-----------------------------------------”. Please clarify what source is currently utilized for BPE manufacture, and if not already using material sourced from the   --b(4)-------- cattle, define when this change will occur.
 
  1. ----b(4)--- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 
---b(4)-----------------
 
  1. Regarding the –b(4)-------------- that is used for Apligraf manufacture, we have not been able to locate information regarding the methods used for monitoring the –b(4)-- used for collection of this reagent and the procedures that are followed to prevent its contamination with prohibited materials during collection. Please provide this information.
 
Primary Packaging
 
  1. In BLA Section 3.2.P.2.6.1, it states that compatibility studies were performed for the tray and lid assembly and culture insert ring. Please provide complete study reports of the following studies that were described briefly in the BLA:
 
    1. –b(4)- Systemic Toxicity Study in Mice
    2. –b(4)- Intracutaneous Toxicity Study in Rabbits
    3. –b(4)- Muscle Implantation Study in Rabbits
    4. Cytotoxicity (NCLVP/R-0332-001)
    5. Extractables (NCLVP/R-0332-001)
    6. Material Identity (NCLVP/R-0332-001)