FamiCord AG, Europe's leading cell bank and the third largest worldwide, announced that its CDMO brand Bramble Bio has entered into a manufacturing agreement with Swedish clinical-stage biotechnology company VERIGRAFT AB. The deal covers the transfer and establishment of the manufacturing process for VERIGRAFT's lead product candidate P-TEV, a personalized tissue-engineered vein, as well as support for sourcing and qualifying donated human vein tissue used as starting material. Technology-transfer activities to Bramble Bio's GMP site in Warsaw, Poland, will begin immediately, with the collaboration expected to run for approximately 18 months and an estimated contract value in the low single-digit millions of euros.
The agreement matters because it adds a pivotal Phase II/III program to FamiCord's CDMO activities, signaling a strategic shift toward late-stage clinical manufacturing. The trial, TECVI-2, is a randomized, controlled, open-label Phase II/III study designed to assess the efficacy of P-TEV in patients with severe chronic venous insufficiency (CVI). Clinical sites are planned in Spain, Poland, and the Netherlands, with Spain already authorized under the EU Clinical Trials Regulation. Approvals in Poland and the Netherlands are expected in Q4 2026, and the trial is anticipated to begin in Q1 2027, supporting future marketing authorization applications in Europe and the United States.
For FamiCord, this contract validates its investments in GMP infrastructure and ATMP expertise. "The agreement with VERIGRAFT marks another concrete step in the development of our CDMO activities," said Jakub Baran, CEO of FamiCord AG. "Supporting a pivotal Phase II/III program requires close technical cooperation, rigorous process control and reliable cross-border logistics. The project broadens our portfolio with a late-stage clinical program and underlines the capabilities we have built at our Warsaw site." Bramble Bio also operates a GMP site in Cantanhede, Portugal, and supports clients with technology transfer, process development, GMP manufacturing, and international logistics.
VERIGRAFT's P-TEV is a fully biological tissue-engineered vein with a functioning valve, developed to restore venous function without immunosuppressive treatment. The manufacturing process involves decellularizing donated vein tissue to preserve the native matrix and valve structure, then reconditioning it with the patient's own blood to create a personalized graft. "Establishing a robust and scalable manufacturing capability is fundamental to the successful delivery of TECVI-2 and to the future development of P-TEV," said Petter Bjorquist, CEO of VERIGRAFT. "Bramble Bio combines specialist ATMP manufacturing expertise with the flexibility and commitment required for a complex, personalized therapy."
The collaboration underscores the growing demand for specialized CDMO services in advanced therapies. For FamiCord, it complements recurring storage revenues and provides exposure to the rapidly growing ATMP market. Further information on FamiCord can be found at www.famicord.com, and details on VERIGRAFT are available at www.verigraft.com. The original release is available at www.newmediawire.com.
