Shire plc , the global specialty biopharmaceutical company, has received the approval from European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use for the production of VPRIV (velaglucerase alfa) in its new state-of-the-art manufacturing facility at 400 Shire Way in Lexington, Massachusetts. The European Commission’s decision is expected imminently.
“We welcome the news that Shire's new manufacturing facility in Lexington has received EMA approval for the production of VPRIV,” said Tanya Collin-Histed of the European Gaucher Alliance. “This provides patients with greater comfort over the maintenance of supply of enzyme therapies for the treatment of Gaucher disease.”
Shire now has two EMA approved facilities – Alewife, in Cambridge, Massachusetts, as well as the new Lexington facility – in which to manufacture VPRIV drug substance. This additional capacity will allow Shire to significantly increase global supply of VPRIV and provides additional manufacturing flexibility. The EMA approval is also a critical first step in releasing further capacity for the manufacturing of REPLAGAL (agalsidase alfa) at Shire’s Alewife facility. The new facility increases bioreactor capacity from 1000 to 8000L, and is the first commercially licensed facility in the world to utilize single-use bioreactor and disposable technology throughout cell culture processing to reduce manufacturing risk.
“I am delighted to announce the EMA approval of our facility. 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," said Bill Ciambrone, senior vice president, technical operations, Shire HGT. “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 has invested over $200 million in manufacturing infrastructure and technology to ensure that we maintain a reliable and consistent drug supply. In keeping with Shire’s corporate sustainability commitments, this new manufacturing plant has met the requirements for Leadership in Energy and Environmental Design (LEED) Certification and will receive formal recognition from the United States Green Building Council this quarter. 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.
VPRIV 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 is used for the long-term treatment of patients with type 1 Gaucher disease.
VPRIV is approved in 38 countries globally, including the US, the European Union, and Israel and is for patients who are treatment-naïve as well as patients who have previously been treated with imiglucerase.
REPLAGAL 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. REPLAGAL is not currently approved for commercial sale in the US.
REPLAGAL 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 (a-Gal A deficiency).