Test Results Memo - Ruconest

Food and Drug Administration
 CBER/OCBQ/DBSQC
 1401 Rockville Pike
 Rockville, MD  20852


 

From:       Alfred Del Grosso, Ph.D.  HFM-682, LACBRP, DBSQC

                           Mark Levi, Ph.D.  HFM-682, LACBRP, DBSQC

                           Ritu Agarwal, Ph.D. HFM-682, LACBRP, DBSQC

Subject:     Test Results for 1) Purity by ----------------(b)(4)----------------- and 2) Residual Moisture for Pharming Group N.V. recombinant human C1 esterase inhibitor
STN: 125495/0
 Lots   ---------(b)(4)-----------
               
To:         File STN 125495/0

Through:    Lokesh Bhattacharyya HFM-682 Lab Chief LACBRP, DBSQC

William McCormick HFM-680, Director DBSQC

Summary of Testing:   Test results by DBSQC are in compliance with Pharming Group N.V. proposed drug product specifications.

1) Purity by (b)(4)

The determination of purity in the rhC1INH drug product was performed using the ----------------------(b)(4)------------------- method submitted by Pharming Group N.V (SOP ALV 8151).  CBER analyst was Mark Levi.  ------------------------------------------------------- --------------------------------------------------------------------------------------- --------------------------------------------------------------------------------------------------(b)(4)----------------------- ----------------------------- ----------------------------------------------- ---------------------------------------------------------- -------------------------------------------------------------------- -----------------------------------------------------------------------------------.

                            (b)(4)                  ---(b)(4)---.                                                     
 (b)(4)               (b)(4)     -(b)(4)-           (b)(4)                              
 (b)(4)               (b)(4)      (b)(4)            (b)(4)                                  
 (b)(4)               (b)(4)      (b)(4)            (b)(4)                                  
 (b)(4)               (b)(4)      (b)(4)            (b)(4)                                 

Pharming Group N.V. has proposed a specification for Purity -----------(b)(4)-----------.  Test results for the above lots by both CBER and the sponsor meet this criterion.

2) Residual Moisture (CBER TMID 000476)

Determination of residual moisture content was performed by CBER using Karl Fischer coulometric titration with methanol extraction of the lyophilized sample (DBSQC Test Method Doc. ID 000476).  CBER analyst was Ritu Agarwal.  Each lot result represents the average of six titrations from the extracted contents of a single vial.  Pharming Group N.V. (b)(4) uses -----------(b)(4)------------- for moisture determination in the final product. Test results are as follows:
                                                                        
                             CBER                         Pharming N.V.     
Lot#                % w/w Moisture   Test Date            % w/w Moisture                 
 (b)(4)              1.3             12/30/13                  (b)(4)
 (b)(4)              1.5             12/30/13                  (b)(4)
 (b)(4)              1.5             12/30/13                  (b)(4)

Pharming Group N.V. has specified a release limit for residual moisture of ----(b)(4)------- for this product. CBER test results for these lots meet this criterion along with the batch results submitted by the sponsor.
