Breaking News

Shire’s Lexington Facility Approved for VPRIV Product

By Kristin Brooks | February 14, 2014

Invests $200 million in SUB manufacturing infrastructure

Shire plc received approval from the FDA for the production of VPRIV drug substance (velaglucerase alfa for injection) at its manufacturing facility in Lexington, MA. The facility was previously approved by the EMA for production of VPRIV drug substance.
 
Shire has invested more than $200 million in manufacturing infrastructure and technology to establish a consistent drug supply chain for this treatment. The facility is the first commercially licensed facility to use single-use bioreactor and disposable technology throughout cell culture processing designed to reduce manufacturing risk.
 
"Shire has always been committed to providing uninterrupted treatment for all VPRIV patients at the dose and frequency prescribed by their physicians. We continue to deliver on this commitment," said Bill Ciambrone, executive vice president, Technical Operations, Shire.
blog comments powered by Disqus
  • Staying Ahead in the Small Molecule Space

    Staying Ahead in the Small Molecule Space

    Dr. Matthew Moorcroft, VP Global Marketing, Cambrex||September 8, 2016
    Understand what is happening in the market and react accordingly

  • FDA & Drug Development

    FDA & Drug Development

    Rachelle Du2019Souza, Regulatory Heights Inc.||September 8, 2016
    You must perform the necessary due diligence to stay on top of regulatory developments

  • Patent Law  and Contract Manufacturing

    Patent Law and Contract Manufacturing

    Beverly W. Lubit, Member of the Firm, Chiesa Shahinian & Giantomasi||September 8, 2016
    Analyzing the impact of The Medicines Co. vs. Hospira Inc. decision