EMA Green-Lights Shire’s Manufacturing Site in Lexington, MA, for Gaucher Therapy
Facility increases capacity from 1,000 to 8,000 L and uses disposable technology.!--h2>
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use has given Shire the go-ahead to produce Vpriv® (velaglucerase alfa) in its new manufacturing facility in Lexington, MA. Shire now has two EMA approved facilities to manufacture Vpriv; the other site is in Alewife, in Cambridge, MA. The medication is used for the long-term treatment of patients with type 1 Gaucher disease.
The new facility increases bioreactor capacity from 1,000 to 8,000 L. It marks the first commercially licensed facility in the world to utilize single-use bioreactor and disposable technology throughout cell culture processing to reduce manufacturing risk.
In addition to increasing capacity and reducing manufacturing risk, utilization of single-use technology requires approximately 80% less water and 50% less energy than a conventional manufacturing plant, according to Shire. This new manufacturing plant also has met the requirements for Leadership in Energy and Environmental Design Certification and will receive formal recognition from the United States Green Building Council this quarter.
Shire reportedly invested over $200 million in manufacturing infrastructure and technology. "Shire has invested strategically in new manufacturing facilities and state-of-the-art technology because we recognize the critical importance of ensuring the continuity of treatment for patients with rare and life-threatening diseases," says Bill Ciambrone, svp, technical operations, Shire Human Genetic Therapies.
"The EMA approval of Vpriv in this manufacturing plant, only three years after breaking ground, is a testament to the hard work and dedication of Shire employees, and represents crucial additional capacity for manufacturing our enzyme-replacement therapies for Gaucher and Fabry patients." Shire says that the capacity added by the Lexington plant will allow it to significantly increase global supply of Vpriv and provide additional manufacturing flexibility. The drug is made using Shire's gene-activation technology in a human cell line. The enzyme produced has the exact human amino acid sequence as that found in the naturally occurring human enzyme.
Vpriv gained FDA and EC sanction in February and August, 2010, respectively. It is now approved in 38 countries including Israel and is for patients who are treatment-naïve as well as patients who have previously been treated with imiglucerase. Vpriv sales in 2011 reached $256 million. That is 6% of total 2011 revenues and up 79% from 2010’s level of $143 million.
The EMA approval of the Lexington facility is also the first step in releasing further capacity for the manufacturing of Replagal® at Shire's Alewife facility. It is the only human-cell-line-derived form of enzyme replacement therapy that is indicated for the long-term treatment of patients with a confirmed diagnosis of Fabry disease. The drug is a human form of enzyme alpha-galactosidase A (a-Gal A) manufactured in a human cell line by gene activation. 2011 marked the 15th year of clinical experience with Replagal, which is now approved in 46 countries worldwide, but not in the U.S.