Regenerative medicine firm has contracted the German Red Cross Blood Donor Service to expand production of its autologous bone marrow-based cell therapy REX-001.

London, UK-headquartered firm Rexgenero’s lead product is REX-001 is in two Phase III trials both of which are in diabetes patients.

The firm manufactures the autologous cell therapy from its production site in Seville, Spain, added through its incorporation of Spanish subsidiary Rexgenero Biosciences S.L in 2015. But to increase production and expedite clinical trials, the firm has taken on the services of the German Red Cross Blood Donor Service which will act as a contract manufacturing organization (CMO) from its site in Frankfurt, Germany.

Rexgenero now has manufacturing capabilities in Spain and Germany. Image: iStock/Golden_Brown

“A second site increases capacity enabling the company to recruit patients more quickly into the trial,” Rexgenero CEO Joe Dupere told Bioprocess Insider. “Another benefit for the company is in demonstrating again the ability to technology transfer our manufacturing process to new sites.

“A second site also provides considerable flexibility with flight routes which facilitates logistics across the whole of Europe.”

The supply chain between the manufacturing and the trial site is important across all biotherapeutics, but for autologous cell therapies it is critical to ensure fresh administration, thus a robust production and logistics network is necessary.

While Rexgenero’s own site will primarily service trials in Spain and Portugal, the Frankfurt site will have the capacity to supply trials in Germany, Poland, Czech Republic, Hungary, The Netherlands, the UK and Austria.

REX-001

REX-001 is made from a patient’s own bone marrow.

“The product is manufactured by physical separation of cells using a cell separation device removing red blood cells, platelets and other components of bone marrow ending with the active cells involved in immune modulation and regeneration,” Dupere told us.

With the additional manufacturing site, he added Rexgenero has sufficient capabilities to run our Europe clinical trials.

However, “we will need to establish additional facilities to conduct studies outside of Europe,” he said.