DBSQC Chemical Test Results Memorandum - MenHibrix

Food and Drug Administration
Center for Biologics Evaluation and Research
OVRR/DPQ
1401 Rockville Pike
Rockville, MD  20852

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

To:                         Pending File STN 125363/0
                                                                                  
Through:                     Lokesh Bhattacharyya, Ph.D., Chief LACBRP, DBSQC, OCBQ HFM-682
William McCormick, Ph.D., Director DBSQC, OCBQ, HFM-680
                              
Subject:                 DBSQC Chemical Test Results for Glaxo Smith Kline Biologicals MenHiberix® (Meningococcal Groups C and Y and Haemophilus b Tetanus toxoid Conjugate Vaccine), Bulk Conjugate Lots and Final Container Vaccine Lots             

Summary of DBSQC / CBER TestingIn support of the review of this biological product license application, the following tests were performed by DBSQC / CBER

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Final Container Vaccine

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All results of DBSQC / CBER testing met the specifications as submitted by the manufacturer at the time of testing.  As detailed in this memo, several specifications were updated in response to a complete review of the application.   CBER test results met all new specifications in those cases where the test method was not significantly modified.    Details of testing and results are as follows:

Bulk Conjugate Drug Substance Testing

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Lot Number          CBER           
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7 pages redacted due to (b)(4)