Shire leader provides update on FDA certification
Massimiliano Barberis, interim site lead for the Georgia manufacturing Facilty of Shire, said the Covington pharmaceutical plant is in its most critical point for the life of the plant.
Currently the plant is preparing to begin Conformance Runs, which is where it will run the full manufacturing process from start to finish using real materials and producing real product.
Barberis said during this process, Shire will be under the watchful eye of the Food and Drug Administration (FDA) and, if successful, will receive its license in about six months. Once the license is obtained, commercial production can begin and product can be sold in the U.S.
He said failing the FDA certification is not an option because of the millions of dollars that would be lost for the company.
“We remain on schedule to get approval and begin commercial production in 2018,” Gabe Khouli, internal communication specialist for Shire, said.
Khouli said Shire has hired more than 800 full-time employees in Georgia to date, including the manufacturing facility and three BioLife plasma collection centers in Douglasville, Snellville and Warner Robins. It employs approximately 700 full-time Shire employees at the Georgia facility in addition to approximately 200 contractors who re- main with the project.
The Georgia location, an investment of more than $1 billion that covers more than 1 million square feet, increases Shire’s capacity for Immunology products. It has an Immunoglobulin product to treat primary immunodeficiency and an Albumin product for use in critical care and trauma situations, Khouli said.
Construction began in 2012 and was completed in 2016. It is expected to ramp up to full production in the first few years once it receives the FDA licensing, which is expected in 2018.
Born in Northern Italy, Barberis started with Shire in 2011 to help with the Italian location. He has since been brought to Georgia to help with the certification of the Georgia location.
The administration building is home to the majority of Shire offices and conference rooms.