Carmell Therapeutics Expands Mfg. Capabilities

On the heels of a pre-IND meeting with the FDA, Carmell Therapeutics said it is significantly advancing the company's clinical and regulatory strategies driving the company's need to expand its manufacturing facilities.

Carmell is a biotech focused on the development and commercialization of regenerative medicine technologies, and will soon be conducting a Phase III clinical study for its first product/indication, bone healing accelerant, based on its core 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. According to the company, a benefit of this patented technology is its ability to control the breakdown of PBM in the body, releasing a broad 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 located at 2403 Sidney Street in Pittsburgh, PA on May 22, 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 FDA, EMA and other regulatory bodies around the world," said Randy Hubbell, president and chief executive officer, Carmell.