– Expanded state-of-the-art facility provides capacity for clinical and commercial development of StrataGraft, if approved
– Investment marks Mallinckrodt’s continued commitment to clinical development and manufacturing in the Madison community
STAINES-UPON-THAMES, United Kingdom, April 24, 2019 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today celebrated the completion of its expanded operations and manufacturing facility for the investigational StrataGraft® regenerative skin tissue, in Madison, Wis. Stratatech, a Mallinckrodt company, recently completed patient enrollment in its ongoing pivotal Phase 3 clinical trial, which is evaluating the efficacy and safety of StrataGraft in the promotion of autologous skin regeneration of complex skin defects due to severe thermal burns that contain intact dermal elements.
The 35,000-square-foot facility provides the necessary capacity to develop and manufacture StrataGraft regenerative skin tissue for both clinical trials and commercial availability, if approved by the FDA. The state-of-the-art facility offers a fully sterile environment for manufacturing, with controlled temperature, humidity and constant carbon dioxide levels. It also features biosafety cabinets, incubators, freezers, a quality control lab and a warehouse for shipping.