LIVERPOOL, United Kingdom & RESEARCH TRIANGLE PARK, N.C., & OEIRAS, Portugal--(BUSINESS WIRE)--Eden Biodesign, a globally-integrated provider of biopharmaceutical process development, cGMP manufacturing and consultancy services, today announced it has been selected by Biotecnol SA to manufacture Cardiotrophin-1 for potential use in certain liver indications.
Eden Biodesign will generate the master cell bank and provide cGMP manufacture of drug substance for use in Phase I clinical trials. The manufacture of Cardiotrophin-1 will be undertaken in Eden Biodesign’s cGMP manufacturing suites at its licensed facilities located in Liverpool, UK.
Crawford Brown, PhD, Chief Executive Officer, Eden Biodesign commented: “We are delighted to be able to add Biotecnol to the wide range of established global pharmaceutical and biotechnology companies that have recognized Eden Biodesign’s expertise and long experience in the development and cGMP production of biopharmaceuticals derived from all major production platforms,” said Crawford Brown, PhD, chief executive officer for Eden Biodesign. The contract signifies Eden Biodesign’s continued strong growth in the marketplace and we are particularly pleased to be working on such an important product for treatment of serious hepatic conditions.”
Biotecnol SA is a biotechnology company that develops biopharmaceutical products, and it has a special focus on the development of novel antibody-based therapeutics to treat life-threatening diseases such as cancer. Together, Biotecnol and Digna Biotech are developing recombinant human CT-1 as a first-in-class drug to reduce ischemic reperfusion injury associated with organ transplantation and liver resection due to primary and secondary tumors, mainly originating from colorectal cancers. Both applications have a growing market with large unmet needs. CT-1 has already been granted Orphan Drug Status by the EMEA prevention of ischemia/reperfusion injury associated with solid organ transplantation; a similar application has been granted by the FDA.
“Cardiotrophin-1, is being developed for use in various applications in hepatology. This program is of strategic importance to both Biotecnol’s and Digna’s growth strategy. Biotecnol looked thoroughly across a wide competitive landscape considering a number of important criteria before we settled on Eden Biodesign,” said Dr. Philip Cunnah, Senior Director Process Development and Manufacturing, Biotecnol SA. “In Eden Biodesign we have found a competent manufacturing partner with the team and facilities, to implement the process developed at Biotecnol and manufacture Cardiotrophin 1 of an appropriate standard to support our clinical trials. We look forward to great results from working together and to expand this collaboration.”
Earlier this month, Biotecnol and Digna Biotech announced that they have entered into an Exclusive License and Option Agreement with Genentech, Inc. a wholly-owned member of the Roche Group, for developing and commercializing Cardiotrophin-1 for potential use in certain liver indications.
About Eden Biodesign
Eden Biodesign is a globally-integrated biopharmaceutical company offering consultancy, biopharmaceutical design, process development and cGMP manufacturing services to leading biotech and pharmaceutical clients around the world. With a reputation for commercializing biopharmaceutical products and processes, the company offers expertise and guidance in multiple sectors. Eden Biodesign’s world class facilities and knowledge in process development, manufacturing, regulatory and technology transfer support ensure that Eden Biodesign offers much more than a traditional CMO. Find out more at www.edenbiodesign.com.
Biotecnol is a biotechnology company developing biopharmaceutical products, and has a special focus on the development of novel antibody-based therapeutics to treat life threatening diseases such as cancer. Biotecnol has a proprietary antibody format, which allows to develop multi-specific antibodies against various cancer targets. These formats are called Tribodies™. Biotecnol is committed in building value by developing a diverse pipeline of antibody products to address unmet healthcare needs. Biotecnol has a presence in the USA and carries its product development activities via its fully owned subsidiary Biotecnol Pharmaceuticals Inc.
Through its facilities in Portugal, Biotecnol leverages its business income by establishing in-house partner-led or collaborative programs, which provide Biotecnol a strong client-based activity and an established track record. Find out more at www.biotecnol.com.