Product Approval Information
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.