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 agreement covers the transfer and establishment of the manufacturing process for VERIGRAFT’s lead product candidate P-TEV, as well as support for the sourcing and qualification of donated human vein tissue used as starting material for P-TEV manufacturing. The collaboration supports preparations for the pivotal Phase II/III trial TECVI-2 and further expands FamiCord’s CDMO activities.
Technology-transfer activities to Bramble Bio’s GMP site in Warsaw, Poland, will begin immediately. The company will perform the process transfer, manufacturing preparation and related GMP activities required to supply the multi-country clinical trial. The collaboration is expected to run for approximately 18 months and has an estimated contract value in the low single-digit millions of euros, depending on the progress of the clinical program, patient recruitment and the associated manufacturing requirements.
“The agreement with VERIGRAFT marks another concrete step in the development of our CDMO activities,” Jakub Baran, CEO of FamiCord AG, explained. “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.”
TECVI-2 is a randomized, controlled, open-label Phase II/III pivotal clinical trial designed to assess the efficacy of P-TEV in a larger patient population. Clinical sites are planned in Spain, Poland and the Netherlands. The trial is currently authorized in Spain, under the EU Clinical Trials Regulation, and approval in Poland and the Netherlands is expected Q4 2026. TECVI-2 is expected to start in Q1 2027, and will evaluate P-TEV as a potentially curative treatment for patients suffering from severe chronic venous insufficiency (CVI). The trial is intended to support future marketing authorization applications in Europe and the United States.
“Establishing a robust and scalable manufacturing capability is fundamental to the successful delivery of TECVI-2 and to the future development of P-TEV. Bramble Bio combines specialist ATMP manufacturing expertise with the flexibility and commitment required for a complex, personalized therapy,” Petter Bjorquist, CEO of VERIGRAFT, added. “We look forward to working closely with their team as we transfer our process and prepare to supply this important multi-country clinical trial.”
P-TEV is a personalized, fully biological tissue-engineered vein with a functioning valve, being developed for patients with severe CVI. The therapy starts with donated venous tissue, which is decellularized to remove donor cells while preserving the native tissue and valve structure. The resulting matrix is then reconditioned with the patient’s own blood to create a personalized graft, designed to replace a diseased vein segment containing a non-functioning valve and restore venous function without requiring immunosuppressive treatment.
Simon Boa, Managing Director of Bramble Bio, sees the project as a sweet spot deal for the company. “Technology transfer and clinical manufacturing for a personalized tissue-engineered product require close technical collaboration, rigorous process control and carefully coordinated logistics. These are core areas of expertise for our CDMO team.”
Bramble Bio supports biotechnology and pharmaceutical companies with technology transfer, process development and optimization, GMP manufacturing, cellular starting-material sourcing, analytical services and international logistics. In addition to Warsaw, Bramble Bio operates a GMP site in Cantanhede, Portugal. Further information on FamiCord and its subsidiaries can be found at www.famicord.com.
The agreement highlights FamiCord’s strategic expansion into contract development and manufacturing for advanced therapies, complementing its established cell banking business. For VERIGRAFT, partnering with an experienced CDMO is critical to advancing P-TEV through late-stage clinical development and toward commercialization. The original release can be viewed on www.newmediawire.com.
