Biologics CDMO Celonic Group has signed a multi-year commercial manufacturing agreement with Lindis Biotech.
Under the terms of the agreement, Celonic will be responsible for the manufacture of Lindis Biotech's bispecific monoclonal antibody, catumaxomab.
The first-in-class therapeutic is trifunctional, and can be used to treat malignant ascites — an abnormal accumulation of peritoneal fluid — in adults with EpCAM-positive carcinomas.
Currently, the biologic is approved for use in patients who are not eligible for any other systemic anticancer therapy.
Celonic will utilise its GMP manufacturing facility in Heidelberg, Germany to produce catumaxomab.
"Partnering with Celonic Group is a vital part of our mission to bring catumaxomab to patients suffering from malignant ascites and fill this unmet clinical need," noted Dr Horst Lindhofer, CEO of LINDIS Biotech.
With Celonic's proven manufacturing capabilities and commitment to quality, we are confident in their ability to ensure a reliable and high-quality supply of our innovative therapy."
Samanta Cimitan, CEO of Celonic Group, added: "We are honored to collaborate with LINDIS Biotech on the production of catumaxomab. This partnership underscores our dedication to supporting the development and commercialization of groundbreaking biologics that address unmet medical needs."