Mallinckrodt has completed the expansion of its operations and manufacturing facility for the investigational StrataGraft regenerative skin tissue, in Madison, WI. 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, also known as deep partial-thickness burns. The safety and effectiveness of StrataGraft have not yet been established by the U.S. FDA.
 
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.
 
“The expansion of our StrataGraft regenerative skin tissue manufacturing facility and enrollment of the final patient in our pivotal Phase 3 trial represent important milestones in the development of this investigational therapy, which we hope to bring to patients with severe burns as a paradigm-changing treatment,” said Mark Trudeau, president and chief executive officer, Mallinckrodt. “Initially developed in Madison, StrataGraft has benefited from public/private efforts to advance its development both in Wisconsin and through a partnership with BARDA, including this new facility.”
 
The celebration featured a ribbon-cutting ceremony with remarks by Wisconsin Gov. Tony Evers; U.S. Rep. Mark Pocan (D-Wis.); and Mr. Trudeau among others.
 
“Our motto in Wisconsin is Forward, which speaks to our continuous efforts to drive forward and succeed,” said Gov. Evers. “The opening of this facility is a solid example of this, and we are proud Wisconsin can play a role in driving forward scientific innovation that can positively impact patients in need.”
 
“It’s exciting that Madison has become a life science hub, and the investment of significant resources to expand the manufacturing facility here is a testament to that,” said U.S. Rep.  Pocan. “With Mallinckrodt as a life sciences partner, we can continue advancing our scientific understanding and strengthening Wisconsin’s position as a leader in technology and innovation.”
 
Mallinckrodt anticipates submitting a Biologics License Application in 2020 with the FDA if data from the Phase 3 trial of StrataGraft regenerative skin tissue is supportive. The FDA has granted StrataGraft orphan drug status, and it was among the first products designated by the Agency as a Regenerative Medicine Advanced Therapy under the provisions of the 21st Century Cures Act.