The QMN Weekly Bulletin

Genyzme is anticipating that the FDA will decide by Nov. 29 whether to approve its BLA for a scaled-up manufacturing process for Pompe disease treatment Myozyme, the company says in a statement.

Myozyme (alglucosidase alfa) is approved by the FDA but only at the 160-liter pilot production scale. The company is seeking approval to market versions of the biologic made at the 2,000-liter scale. Genzyme’s plant in Boston manufactures the enzyme replacement therapy on the 2,000-liter platform for international markets, but the FDA has not approved products made at that facility.

The firm’s other plant, located in Framingham, Mass., is approved by the agency but only manufactures the product at a 160-liter pilot scale. “The agency views alglucosidase alfa manufactured at the 2,000-liter scale as a separate product because of differences in its carbohydrate structure,” the company says in a statement.