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.
