Celonic secures commercial manufacturing deal for EMA-approved catumaxomab
Celonic Group, a dedicated biologics contract development and manufacturing organisation (CDMO), has finalised a multi-year commercial manufacturing agreement with LINDIS Biotech for catumaxomab production. The announcement, made on 19 February 2025, establishes Celonic’s Heidelberg facility as the manufacturing hub for this first-in-class therapeutic antibody.
Clinical significance of the partnership
Catumaxomab represents a significant advancement in the treatment landscape for malignant ascites, a condition characterised by abnormal fluid accumulation in the peritoneal cavity that commonly develops in patients with advanced-stage cancers. The trifunctional bispecific monoclonal antibody has received marketing authorisation from the European Medicines Agency (EMA) specifically for intraperitoneal administration in adults with epithelial cell adhesion molecule (EpCAM)-positive carcinomas who are not eligible for other systemic anticancer therapies.
The condition presents substantial clinical challenges and is associated with significant morbidity. Prior to catumaxomab’s approval, therapeutic options were limited primarily to palliative measures, including paracentesis procedures to drain accumulated fluid. The introduction of a targeted therapeutic approach addresses a previously unmet clinical need in oncology practice.
From left to right: Samanta Cimitan, CEO Celonic Group, Horst Lindhofer, CEO LINDIS Biotech.
Manufacturing considerations
The production of bispecific antibodies presents unique technical challenges compared to conventional monoclonal antibodies. Trifunctional antibodies, such as catumaxomab, involve even greater complexity in their manufacturing processes, requiring specialised expertise and facilities.
Celonic’s Heidelberg manufacturing facility, which will handle the commercial production of catumaxomab, is designed to meet stringent Good Manufacturing Practice (GMP) requirements necessary for biologics production. The company’s selection for this partnership reflects their established capabilities in complex biologics manufacturing.
Dr. Horst Lindhofer, CEO of LINDIS Biotech, emphasised the strategic importance of this manufacturing partnership, stating: “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. 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.”
Technical aspects of catumaxomab
As a trifunctional bispecific antibody, catumaxomab exhibits a unique mechanism of action that differentiates it from conventional therapeutic antibodies. The molecule simultaneously binds to three different cell types: tumour cells (via EpCAM), T cells (via CD3), and accessory immune cells (via Fc receptors). This tri-cell binding capability enables catumaxomab to create an immunological synapse that facilitates targeted destruction of EpCAM-positive tumour cells.
The intraperitoneal administration route allows for direct delivery to the site of malignant ascites formation, potentially improving efficacy while reducing systemic exposure and associated adverse effects. This localised approach is particularly relevant for patients with advanced malignancies who may have limited tolerance for additional systemic treatments.
Manufacturing partnership implications
The agreement between Celonic Group and LINDIS Biotech represents a significant development in the commercialisation pathway for catumaxomab. Commercial-scale production of complex biologics requires substantial infrastructure investment and specialised expertise, which Celonic brings to the partnership.
Samanta Cimitan PhD, CEO of Celonic Group, commented on the collaboration: “We are honoured to collaborate with LINDIS Biotech on the production of catumaxomab. This partnership underscores our dedication to supporting the development and commercialisation of groundbreaking biologics that address unmet medical needs.”
Future perspectives
The establishment of reliable commercial manufacturing capabilities for catumaxomab may facilitate broader clinical adoption of this therapeutic approach for malignant ascites. Additionally, the successful commercialisation of trifunctional antibodies could potentially encourage further development of similar modalities for other oncological indications.
While the current marketing authorisation focuses specifically on malignant ascites in patients with EpCAM-positive carcinomas who are not eligible for other systemic anticancer therapies, future clinical investigations may explore additional applications for catumaxomab or related trifunctional antibodies.
The manufacturing agreement between Celonic Group and LINDIS Biotech represents a significant step towards ensuring consistent commercial supply of catumaxomab for patients with malignant ascites. By leveraging Celonic’s manufacturing expertise and facilities in Heidelberg, LINDIS Biotech aims to establish reliable production capability for this first-in-class trifunctional antibody, addressing an important unmet need in oncology care.
