Sanofi Gains Regulatory Approval for Expansion at Site in Ireland - - BioPharm International

ADVERTISEMENT

Sanofi Gains Regulatory Approval for Expansion at Site in Ireland



Sanofi’s subsidiary Genzyme has received approval from FDA and EMA for a second operation for a fill–finish product at its Waterford, Ireland, manufacturing plant.

With this approval, Genzyme has nearly doubled its ability to fill–finish Myozyme and Lumizyme (alglucosidase alfa) produced at the 4000-L bioreactor scale. Genzyme also will begin the process to secure FDA and EMA approvals to fill–finish additional products in the second suite, with the long-term goal to use the Waterford site as a fill–finish platform across its portfolio of products.

Genzyme’s Waterford facility has been in operation for more than 10 years, and a $150-million expansion was completed earlier this year. The Waterford manufacturing site employs over 500 people and is considered Genzyme’s center of excellence for aseptic manufacturing.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

J&J Speeds Ebola Vaccine Development and Expands Production
October 24, 2014
GSK Accelerates Ebola Vaccine Development
October 24, 2014
Despite AbbVie Snub, Shire Says it Will Double Sales by 2020
October 24, 2014
Manufacturing Challenges of mAb Production: CHO or Plant Cells?
October 24, 2014
Novartis Reports Positive Results for Secukinumab in Ankylosing Spondylitis Trials
October 23, 2014
Author Guidelines

Click here