Carmell Therapeutics recently held a pre-IND meeting with the FDA, advancing the company's clinical and regulatory strategies and driving the company's need to expand its manufacturing facilities.
Carmell will soon conduct a Phase III clinical study for its first product/indication, Bone Healing Accelerant. This will be the first product and indication based on its Plasma-based Bioactive Material (PBM) technology. The PBM technology was developed at Carnegie Mellon University and utilizes pooled plasma to create products which accelerate the healing of both bone and soft tissues. A benefit of this patented technology is its ability to control the breakdown of PBM in the body, releasing a range of growth and healing factors over different periods of time when the body needs them most to accelerate healing.
To expedite commercialization, Carmell has secured a site for its new, state-of-the-art manufacturing facility. Carmell will move its headquarters, including the R&D lab and manufacturing capacity, to a new facility in Pittsburgh in May 2017.
"Designing the manufacturing site to fit our specific product needs and now being able to include product manufactured at our new facility in the clinical trial will allow for a seamless regulatory submission to the US FDA, EMA and other regulatory bodies around the world," Randy Hubbell, President & CEO of Carmell said.