March 14, 2023
BioTissue Expands Florida Manufacturing Facility
Project Increases Capacity to Meet Growing Demand, Prepares for Biologics License Application to the FDA
MIAMI, March 14, 2023 – To accommodate current and future growth of its biologics product portfolio, BioTissue recently completed an expansion and renovation of its manufacturing and distribution facility in Doral, Florida. The project includes an 1,800-square-foot addition of new cleanroom space and the renovation of 9,000 square feet to align with the U.S. Food and Drug Administration’s (FDA’s) Current Good Manufacturing Practice (CGMP) regulations.
BioTissue is a leader in the application of cryopreserved human birth tissue products for regenerative healing of ocular surface disease and disorders, chronic wounds, and musculoskeletal conditions.
The upgraded and expanded facility prepares BioTissue for its upcoming FDA Biologics License Application process and increases the company’s product manufacturing capacity to keep up with current and expected future demand.
“At BioTissue, our evidence-based innovation has outpaced the world of regenerative medicine for more than three decades, and as we look to the future, we’ll continue to pioneer high-performance healing,” said BioTissue CEO Ted Davis. “The expansion and renovation of our manufacturing facility puts BioTissue in a position to continue innovating to provide effective, reliable products that help physicians improve the lives of their patients.”
In addition to increasing the facility’s footprint, upgrades to align with FDA CGMP regulations include the installation of two dedicated air handling units, airlocks, a new instrument processing room with ISO 8 classification, a new packaging and labeling room, and installation of hard gypsum ceilings and epoxy flooring.
The Doral facility serves as the manufacturing, packaging, and shipping hub for BioTissue’s leading amniotic membrane product families Prokera®, AmnioGraft®, AmnioGuard®, Neox®, and Clarix®. These products use the company’s proprietary CryoTek® cryopreservation technology designed to retain the tissue’s structural and functional integrity.
About BioTissue, Inc.
BioTissue is an emerging biotechnology company and leader in harnessing the unique power of human birth tissue to support regenerative healing for ocular surface disease and in surgical, chronic wound, and musculoskeletal applications. BioTissue’s portfolio of cryopreserved amniotic membrane products use its proprietary CryoTek® cryopreservation technology, designed to retain the tissue’s structural and functional integrity. The company continues to break new ground with multiple investigational new drug clinical trials as the company pursues biologics license applications for products to treat patients’ unmet clinical needs. BioTissue is committed to empowering healthcare professionals with solutions to deliver optimal patient outcomes by fostering innovation through evidence-based science. Since its inception, clinicians have performed over 790,000 human implants with its products and published over 390 peer-reviewed studies supporting BioTissue’s platform technology. Learn more at biotissue.com.
McDougall Communications for BioTissue
[email protected] (585) 434-2154