Lonza, a global leader in biological development and manufacturing, announced today the release of its second-generation immunogenicity assessment platform. The upgraded platform consists of state-of-the-art in silico and in vitro/ex vivo technologies to evaluate immunogenicity risk during the pre-clinical development of therapeutic proteins. In the context of vaccine and cell therapy development, the platform enables the rational design and testing of optimal immune responses in healthy donor or patient populations.

This second-generation platform provides a comprehensive toolbox to assess customers’ early-stage candidates for immunogenicity risk. The platform also provides tools for deimmunization to reduce immunogenicity risk through the identification and removal of T cell epitopes. Major components of the upgraded platform include:

• Epibase^®in silico version 4 immunogenicity platform supports T cell epitope prediction with enhanced accuracy by the addition of a TCR facing filter
• MHC-associated peptide proteomics (MAPPs) identify HLA binding peptide profiles from whole proteins naturally processed and presented by human dendritic cells
• Enhanced T cell activation assays confirm T cell epitopes identified in silico or MAPPs with highly sensitive CD4 and CD8 T cell re-stimulation assays using a dual-color FluoroSpot readout
• Cytokine release assay (CRA) assesses risk of the candidate inducing a dangerous cytokine response with cytokine profiles assessed by Luminex® reagents.
• Pre-existing antibody assessment detects total and antigen specific  IgA, IgG, IgE, and IgM secreting B cells using the B Cell FluoroSpot Assay

Together with Lonza’s manufacturability assessment tools and non GMP material supply, it is possible to identify potential risks during late discovery/early development and select a lead candidate with an optimal product profile. Furthermore, the highly diverse platform of primary cell assays also provides an assessment of the immune response in a fully human platform prior to clinical trials.

“Since its introduction more than 15 years ago, we have continuously improved our Epibase^® immunogenicity platform,” said Karen Fallen, Head of Lonza’s Clinical Development and Licensing Business Unit. “Our comprehensive toolbox combined with our capability to provide material suitable for preclinical testing supports our customers’ development needs from early design to CGMP production. Lonza is the only CDMO that helps our customers progress their candidates seamlessly through the discovery and development process.”