FamiCord AG, Europe's leading cell bank and the third largest worldwide, announced on September 24, 2026, that its CDMO brand Bramble Bio has signed a manufacturing agreement with Swedish clinical-stage biotechnology company VERIGRAFT AB. The deal covers the technology 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. The collaboration is a strategic win for FamiCord, adding a pivotal Phase II/III program to its CDMO activities and underscoring the capabilities of its Warsaw GMP site.
The agreement is expected to run for approximately 18 months, with an estimated contract value in the low single-digit millions of euros. While the immediate financial impact is modest, the strategic importance is significant. By supporting a late-stage clinical trial, FamiCord demonstrates its ability to handle complex, personalized advanced therapy medicinal products (ATMPs) and positions itself as a key player in the growing ATMP market. The trial, TECVI-2, is a randomized, controlled, open-label Phase II/III study designed to evaluate P-TEV in patients with severe chronic venous insufficiency (CVI). It is expected to begin in Q1 2027, with clinical sites planned in Spain, Poland, and the Netherlands. The trial is already authorized in Spain and approvals in Poland and the Netherlands are anticipated in Q4 2026. Success in this trial could lead to marketing authorization applications in Europe and the United States, potentially making P-TEV a curative treatment for a condition that currently lacks effective options.
FamiCord's CEO, Jakub Baran, noted that the agreement marks another concrete step in the development of the company's CDMO activities. "Supporting a pivotal Phase II/III program requires close technical cooperation, rigorous process control and reliable cross-border logistics," he said. "The project broadens our portfolio with a late-stage clinical program and underlines the capabilities we have built at our Warsaw site." Simon Boa, Managing Director of Bramble Bio, described the project as a "sweet spot deal," highlighting the team's expertise in technology transfer and clinical manufacturing for personalized products.
VERIGRAFT's CEO, Petter Bjorquist, emphasized the importance of manufacturing for the trial's success. "Establishing a robust and scalable manufacturing capability is fundamental to the successful delivery of TECVI-2 and to the future development of P-TEV," he said. "Bramble Bio combines specialist ATMP manufacturing expertise with the flexibility and commitment required for a complex, personalized therapy."
P-TEV is a fully biological tissue-engineered vein with a functioning valve. It is created by decellularizing donated venous tissue and reconditioning the matrix with the patient's own blood, resulting in a personalized graft that does not require immunosuppressive treatment. This innovative approach could transform care for severe CVI patients, who often face debilitating symptoms and limited treatment options.
The agreement also highlights FamiCord's broader strategic shift. Once known primarily as a cell bank, the company is expanding its CDMO activities to complement its recurring storage revenues and tap into the rapidly growing ATMP market. With GMP sites in Warsaw and Cantanhede, Portugal, FamiCord offers a range of services including technology transfer, process development, GMP manufacturing, and international logistics. This deal with VERIGRAFT not only adds a late-stage program but also reinforces FamiCord's reputation as a reliable partner for biotechnology companies developing cutting-edge therapies.
For more information on FamiCord, visit www.famicord.com and for VERIGRAFT, visit www.verigraft.com. The original release can be viewed at www.newmediawire.com.
