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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Residual Moisture Test - Wilate, December 10, 2007

Date:      December 10, 2007

From:      Alfred V. Del Grosso, Ph.D., HFM-406, DPQ, OVRR

              Hsiaoling Wang, Ph.D., HFM-406, DPQ, OVRR                    

To:          Timothy Lee, Ph.D., HFM-392, DH, OBRR

Through:   Rajesh Gupta, Ph. D., HFM-407, PQLS, DPQ, OVRR

Subject:   Residual Moisture Test for six (6) Lots of Coagulation Factor VIII/von  
              Willebrand Factor Complex (Human) from Octapharma/1646

                STN 125251_0

Residual moisture was measured by CBER using a Karl Fischer coulometric titration with methanol extraction of the lyophilized samples.  Octapharma’s results are by a ----(b)(4)------------ method described in this BLA submission that is standardized against a -----(b)(4)-------------------- procedure.  Test results are as follows:

Mfr. -(b)(4)- ResultsCBER’s KF Results *
Lot#Moisture (%)Moisture (%)Test
Date
----(b)(4)-----1.10.9305Dec07
----(b)(4)-----1.10.8305Dec07
----(b)(4)-----0.90.7205Dec07
----(b)(4)-----0.91.005Dec07
----(b)(4)-----1.20.9405Dec07
----(b)(4)-----1.0.9705Dec07

Octapharma has proposed a limit for the residual moisture content of -(b)(4)- for this product. Test results obtained by both CBER and the manufacturer meet this specification.

* Moisture values of Lots ---------------------(b)(4)------------------------ are average of 3 samples; moisture values of Lots --------------------------(b)(4)------------------------ are average of 2 samples.

cc: N. Baylor
R. Gupta