MEMORANDUM
Date: July 10, 2014
To: Administrative file for STN 125512/0
From: Noel Baichoo, HFM 681
      DBSQC
Subject: STN 125512/0  Testing of in-support samples for purity by -----------------------------------------(b)(4)------------------------------------------------- and for Identity by ---(b)(4)----------- on Antihemophilic Porcine Factor VIII (recombinant) Drug Product (OBI-1)
Through: William M McCormick, Director DBSQC
CC: Lokesh Bhattacharyya, HFM 681
      DBSQC

Background:
Baxter Healthcare Corporation submitted an IND (10695) for Antihemophilic Factor VIII (Recombinant), Porcine Sequence (OBI-1). Purity of the Drug Product is evaluated by several methods including----------- --(b)(4)--- which produces -------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------. Identity of the Drug Product is evaluated by -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)-------------------------------------------------------------------. CBER received 3 lots of OBI-1 Drug Product for testing. These lots were tested at the DBSQC as described below.
Method:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(b)(4)--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1 Page Determined to be Not Releasable: (b)(4)
[(b)(4)]
Conclusions:
The results summarized in Table 1 show that FVIII purity of all 3 lots submitted for evaluation are within specification limits.
The results summarized in Table 2 show that FVIII identity of all 3 lots submitted for evaluation met specification.
