Home » Genzyme’s Allston Plant GMPs Cited in Lumizyme Refusal
Genzyme’s Allston Plant GMPs Cited in Lumizyme Refusal
November 20, 2009
Genzyme’s Allston, Mass., facility continues to plague the company, which received a complete response letter for Pompe disease treatment Lumizyme,
citing fill-finish good manufacturing practice (GMP) deviations at the plant as a reason for not approving the product.