A robust CHO cell-based process platform for rapid manufacture of novel fully human bispecific monoclonal antibodies with importance for preclinical studies, immuno- and cancer therapies

• Research unit: INNOSUISSE
• Project number: 14450.2;3 PFLS-LS

Short description (German)

A robust CHO cell-based process platform for rapid manufacture of novel fully human bispecific monoclonal antibodies with importance for preclinical studies, immuno- and cancer therapies

Short description (English)

A robust CHO cell-based process platform for rapid manufacture of novel fully human bispecific monoclonal antibodies with importance for preclinical studies, immuno- and cancer therapies

Abstract (German)

The project aims to establish a robust commercial-scale manufacturing platform for the kappa lambda body (¿Û¿Ü-body), a novel fully human bispecific antibody format. This new generation of biotherapeutics considerably extends the application fields of current classical monoclonal antibodies. In order to ensure process robustness and rapid production, a chemically defined minimal culture medium and single-use bioreactors are to be used. The 4 project partners will demonstrate the platform¡¿s suitability for one candidate ¿Û¿Ü-body, which will be correctly glycosylated and folded, with > 2.5 g L-1 of total antibody.

Abstract (English)

The aim of the project is to establish a robust manufacturing platform for novel fully human bispecific monoclonal antibodies (BsmAbs) for preclinical studies, cancer and immunotherapies at liter scale. The fully human BsmAbs (kappa lambda {¿Û¿Ü} body format), which represent a new generation of biotherapeutics, considerably extend the application fields of current classical mAbs. They enable (1) immune cell retargeting to tumors (force cell-cell interaction), (2) dual inhibition (triggering two receptors simultaneously), (3) enhanced specificity (hitting a target only in the presence of a second one), and (4) central nervous system delivery. In order to ensure process robustness and rapid production, a chemically defined minimal culture medium and single-use bioreactors are to be used. The 5 project partners will demonstrate the platform¡¿s suitability for one candidate immunoglobulin G (IgG), which will be correctly glycosylated and folded, with ¿Û¿Ü antibody titer exceeding 1 g L-1.