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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing of Wyeth's BLA for Morocotocog Alfa (AF-CC) - XYNTHA

MEMORANDUM

Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

Date: 6 June 2007
To: File of STN 125264
From: Tim Lee
Subject: Filing of Wyeth's BLA for Morocotocog Alfa (AF-CC)
CC: Pauline Cottrell & Franklin Stephenson

Morocotocog Alfa (AF-CC) is a recombinant antihemophilic factor product manufactured with modifications to the currently licensed manufacturing process for ReFacto bulk drug substance (BDS). The modifications are implemented to eliminate the use of animal- and human-derived proteins in the manufacturing process, and are outlined as folllows:

  • --------------------------------------------------------------------------------------------------------------
  • Elimination of human serum albumin in the cell culture media
  • Replacement of the monoclonal antibody Sepharose resin with a chemically-synthesized affinity ligand resin (TN 8.2)
  • Introduction of a virus-retaining filtration step ---------------------------

In addition:

  • The new reference standard used in the FVIII potency assay was calibrated against the 7th FVIII International Standard (IS) using a one-stage clotting assay. This reference standard replaces the one that was calibrated against the 6th IS using a chromogenic substrate (CS) assay. ReFacto AF will be released using a CS assay.

There were no major changes to the manufacturing process used to make the ReFacto final drug product for Moroctocog Alfa (AF-CC).

After a cursory review of the electronic submission, I find that the CMC information provided is sufficient for me to perform a meaningful review.

Therefore, I consider this BLA to be suitable for filing.