Project Details

  • Client

  • Service

  • Location

    Woburn, MA

A/Z worked with Genzyme to provide design and construction management services for the renovation of its Woburn, MA manufacturing facility. The renovations focused on preparing the facility to safely produce LeGoo®, a water soluble occlusion gel that forms a temporary endovascular plug at body temperature which minimizes the risk of vessel damage during surgery, and BackStopTM, an atraumatic device to prevent stone migration and stone fragment retropulsion during ureteroscopic lithotripsy. An internal assessment of the facility by Genzyme personnel concluded that the facility requirde upgrading to meet cGMP and corporate standards for the production and filling of these two products into syringes. The upgrade required the addition of a locker area and personnel air lock to segregate the manufacturing core from non-production areas, the installation of a new HVAC and environment monitoring systems for cGMP manufacturing rooms, and the upgrade of interior finishes in ISO 7/Grade C and ISO 8/Grade D areas.