The deal gives Stemedica a production plant in Lausanne, Switzerland at a time when it needs to bring additional capacity online to support the expansion of its clinical trial programme into Asia and Europe.
Smith & Nephew used the site for commercial-grade cell manufacturing, work for which it received the approval of the Swiss Agency for Therapeutic Products, the regulator also known as Swissmedic.
Stemedica has knowledge of the site from an earlier collaboration with Smith & Nephew. The collaboration entailed the transfer of Stemedica’s BioSmart Technology Platform to Lausanne and the performance of several engineering runs at the Swiss facility.
Management at Stemedica now plans to tailor the plant to the needs of their operation, which is focused on the production of allogeneic adult stem cells for use in the treatment of chronic heart failure, ischemic stroke and other diseases.
“We are currently working on our plans for recommissioning the facility,” David Cheatham, business manager at Stemedica International told Biopharma-Reporter. The plan will dictate what changes Stemedica makes to the plant and the number of employees it brings on board initially to staff the site.
Long-term staffing goals for the facility are already in place. “Once the facility is fully operational, I expect our staffing could be as high as 25 employees,” Cheatham said.
Stemedica is open to hiring people who used to staff the site for Smith & Nephew or anyone else who meets its requirements. “We will carefully consider all qualified applicants,” Cheatham said.
Global expansion
Stemedica expects to have the facility ready next year. Once that happens, Stemedica will have two operational facilities, with the new site in Lausanne joining a plant in the company’s home city of San Diego, California.
The establishment of a base in Europe will give Stemedica a location from which to produce stem cells for clinical trial sites in the continent and in Asia. As it stands, Stemedica is involved with clinical trials in a handful of regions of the United States, including Arizona, California and New York.
Stemedica has also worked with Novastem to treat patients in Mexico. The collaboration made headlines, not all of them positive, 11 months ago when the family of ice hockey legend Gordie Howe released a statement about Stemedica’s stem cell therapies.
The family said Howe was injected with neural stem cells and one day later could walk for the first time since he suffered a stroke, a response they described as “truly miraculous.” Other observers cautioned about reading too much into the experience of one patient.