Shire Project Atlas
Project Atlas or Building 400 (B400) is an FDA regulated manufacturing facility located at 400 Shire Way in Lexington, Massachusetts. The structure consists of three stories totaling 200,000 square feet with approximately 100,000 square feet of production space and support space each. The project was recognized by ISPE as Facility of the Year Honorable Mention in 2011.
The Atlas facility supports the manufacture of Replagal® (for Fabry disease) and VPRIV® (for type 1 Gaucher disease), as well as a robust product pipeline for future programs.
A number of features make Project Atlas distinctive, but two in particular stand out above the rest: their first-ever use of extensive single-use technologies at commercial scale, and the execution of the project. Together with the construction manager, Lendlease; the engineer/designer, CRB; the architect, KlingStubbins; and the subcontractors and vendors, Shire was able to bring a remarkable facility online under budget and ahead of schedule.
Project Atlas's entire upstream process line utilizes single-use technology: media hold, inoculum preparation, seed and production bioreactors, centrifugal clarification, and harvest filtration and hold.
Atlas is the first plant to use a single-use sterile train at the 2,000 liter scale, which required a number of custom modifications by the Project Atlas team.