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Clinical stage biopharmaceutical developer LINDIS Biotech has partnered with contract development and manufacturing organization (CDMO) Celonic Group to manufacture monoclonal antibody (mAb) therapy catumaxomab for commercial supply.
Swiss firm Celonic will manufacture the drug at its GMP facility in Heidelberg, Germany, which is equipped to handle mid-scale commercial projects using up to six 2,000 L single-use bioreactors.
Catumaxomab is a trifunctional bispecific mAb used to treat malignant ascites in adults with epithelial cell adhesion molecule (EpCAM)-positive carcinomas who are not eligible for other systemic anticancer therapy. Malignant ascites most commonly occur in patients who have advanced-stage cancer and are characterized by an abnormal accumulation of fluid in the abdomen. Catumaxomab has been clinically shown to reduce the signs and symptoms of malignant ascites.
Samanta Cimitan, CEO of Celonic Group, said, "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."
"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,” said 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."
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