Vericel Continuity of Business statement regarding covid-19
Updated May 5, 2020
The Governor of Massachusetts has issued an Executive Order requiring businesses in the Commonwealth that do not provide essential services to close their physical workplaces and facilities to workers, customers and the public through May 18th.
Deemed an essential business, Vericel continues to manufacture and provide patient access to MACI® (autologous cultured chondrocytes on porcine collagen membrane).
Updated March 26, 2020
On Monday, March 23rd, the Governor of Massachusetts issued an Order requiring businesses in the Commonwealth that do not provide essential services to close their physical workplaces and facilities to workers, customers and the public until noon on April 7th. Vericel, as a manufacturer of medical and pharmaceutical products, is considered an essential business under the Governor’s Order. Accordingly, Vericel will continue to manufacture and provide patient access to MACI® (autologous cultured chondrocytes on porcine collagen membrane) moving forward. Customer Care as well as MyCartilageCare® services will remain operational in accordance with normal business practices.
Vericel’s products are aseptically manufactured in an FDA licensed facility using sterile materials and reagents. The clean rooms maintain the highest cleanliness standards through automated environmental controls and monitoring as well as a validated rotational cleaning program of the room and all work surfaces which includes Quality Control testing and release of the rooms; and the use of pre-sterilized gowning materials worn by manufacturing personnel. Laminar flow biosafety cabinets located within the cleanrooms are used for all manufacturing processes. Each phase of manufacturing is monitored and tested for microbial contamination. Following manufacturing, all final products undergo rigorous Quality Control testing including the use of numerous proprietary release assays to ensure that our products are safe, consistent and free of microbial contaminants.
Vericel remains committed to maintaining patient access to MACI during this crisis, and we are equally committed to protecting the health of members of our team and healthcare providers. Point-of-care clinical case support from Vericel personnel will be subject to local, state or federal movement and business activity restrictions as well as facility vendor access rules.