Shire leader pro­vides up­date on FDA cer­ti­fi­ca­tion

The Covington News - - FRONT PAGE - JACKIE GUTKNECHT jgutknecht@cov­news.com

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.

Sub­mit­ted Pho­tos | The Cov­ing­ton News

The ad­min­is­tra­tion build­ing is home to the ma­jor­ity of Shire of­fices and con­fer­ence rooms.

Bar­beris

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