Epibase® In Silico and In Vitro Immunogenicity Platform

Predicting immunogenicity of candidates promotes knowledge-based decisions for lead selection

Our Epibase® platform of in silico immunoprofiling services and in vitro cellular assays predict and compare the immunogenicity risk potential of your biotherapeutic candidates and over 500 known protein sequences. Epibase® in silico and in vitro platforms provide a comprehensive immunogenicity assessment package.

Designed for a wide range of targets:

• Antibodies and antibody fragments
• Biotherapeutic proteins
• Bispecifics
• Biosimilars/Biobetters
• Enzyme replacement therapies
• Plant and bacterial proteins
• Viral vectors
• Synthetic peptide

Supporting lead selection, ranking, optimization and design to identify lower risk candidates before proceeding to in vitro screening

Epibase® in silico (IS) is a T-cell epitope screening platform that analyzes and predicts the potential immunogenicity of proteins.

• The Epibase® tool predicts peptide/HLA binding
• Uses 3D structural characteristics of HLA receptors
• Statistical modelling based on experimentally determined binding affinities of peptides
• Epibase® utilizes population frequencies and covers 99% of the global population (85 HLA allotypes)
• Applies self-peptide filtering (e.g. human antibody germline)
• Enhanced filter recognizing ‘self’ on the level of T Cell Receptor (TCR) facing residues

Save time and money in development

• Our scientific experts perform the work, analyze results and provide consultation on data interpretation
• Rapidly assess biotherapeutic proteins with a high throughput process
• Streamline candidate selection using in silico screening to select lower risk candidates before proceeding to in vitro screening
• Focus R&D resources on a smaller number of protein targets with the greatest chance of success early in development

Our Epibase® in vitro platform directly measures the immune response induced by the protein in peripheral blood mononuclear cells (PBMCs) and can also assess potential off-target binding to healthy cells and immune activation (immunotoxicity). The platform can also be used to assess the impact of a process change or product and process-related impurities on the immunogenicity risk.

Understanding the immune response against your leads in a fully human in vitro system during early development will allow you to manage potential safety risks prior to embarking on clinical trials.

The Epibase® in vitro assays use human peripheral blood mononuclear cells (PBMCs) and in some cases combined with other healthy human tissue cells provides researchers with a human in vitro system to more closely mimic the potential immune response of a patient in the clinic. Whole blood and leukopaks are collected at clinical sites adhering to ethically approved protocols.

Lonza’s Epibase® platform – in vitro immunosafety risk assessment

Assays for all aspects of the immune response