As many of you are aware, a standard part of the biologics drug development process is to incrementally scale-up manufacturing capacity as demand for the product increases. During the development of Myozyme®, Genzyme began the manufacturing process using a smaller scale, and has since scaled-up to produce larger quantities of product for
commercial use worldwide. In addition to the use of this larger scale in multiple clinical trials, we’ve successfully transitioned to commercial use of the larger scale of Myozyme in over 29 countries where we have received regulatory approval. In the United States, we are still in the process of seeking regulatory approval for use of the larger scale
manufacturing process, as it has taken time to produce the necessary data to support the submission to the FDA.
