New Manufacturing Plant in Lexington Receives Honorable Mention
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the Project Atlas manufacturing facility in Lexington, Massachusetts has been recognized with an honorable mention in the ISPE (International Society for Pharmaceutical Engineering) Facility of the Year Awards program.
Project Atlas was selected from a group of 26 state-of-the-art projects constructed in 11 different countries. The Facility of the Year Awards program recognizes pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines.
Among the reasons given for the recognition, the judges noted Shire’s extensive deployment of single-use technologies at commercial scale, and the ability to overcome challenges and make technical adaptations to implement fully single-use upstream process technology at a 2,000 liter scale. As a result, the facility was effectively built faster, with reduced investment and lower utility requirements.
“We are honored to be recognized by ISPE for our work on the Atlas Project,” said Bill Ciambrone, Head of Technical Operations at Shire HGT. “In less than three years, we have successfully built, commissioned, and performed validation runs in a facility that enables us to develop therapies to treat those suffering from orphan diseases around the world. As the ISPE judges noted, Project Atlas is the embodiment of Shire’s vision – which is to be as brave as the people we help.”
The Atlas facility supports the manufacture of REPLAGAL® (agalsidase alfa), VPRIV® (velaglucerase alfa), and Shire’s robust pipeline of future development programs. Along with Atlas, Shire owns four buildings in Lexington that serve as the global center for Shire HGT, the business unit of Shire dedicated to the study of orphan diseases.
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Notes to editors
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights.Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company’s website: www.shire.com.
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Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.