Immunogenicity Prediction Services

Overview

Immunogenicity is the most critical safety issue associated with biologics. Immunogenicity is the ability to induce humoral and/or cell-mediated immune responses. Most biologics induce immune responses because they are polypeptides or proteins and thus can be recognized by the immune system as foreign objects. Given that biologics may induce this unwanted immune response; it is important to study the immunogenicity of biological agents prior to marketing approval.

To help you understand and address the potential issues of drug immunogenicity in your program at any stage, Creative Biolabs has developed Sensitive Immunogenicity Assessment Technology (SIAT) according to specific and EMA guidelines. SIAT-based highly sensitive and unique assessment techniques include in silico assessment and in vitro screening, which are effective in a wide range of applications, including biopharmaceutical quantification, anti-drug antibody (ADAs) assays, and pharmacokinetic / pharmacodynamics efficacy measurements.

In Silico Assessment - T Cell Epitope Screening

Driven by sequencing technology, structural bioinformatics and experimental data analysis, Creative Biolabs has developed the SIAT-based in silico assessment technology, a proprietary T cell epitope screening tool for identifying potential epitopes in biotherapeutic proteins and new antibody targets. The in silico tool predicts potential peptide/HLA binding by mimicking the structural features of the MHC class II and experimentally determines binding affinity, which are prerequisites for T cell activation.

In Vitro Screening

Creative Biolabs's in vitro platform assesses the immunogenicity risk of biologics by directly measuring immune responses using peripheral blood mononuclear cells (PBMCs). When combined with our in Silico tool, these cell analyses allow for a complete immunogenic risk assessment of your primary lead candidate. In vitro assays include:

• Dendritic cell activation
• Cytokine release
• MHC-related peptide proteomics
• T cell response
• B cell response
• Cell binding and cell killing assay

In Vivo Screening

In vitro and ex vivo assays provide a direct preview of the immunogenicity of biotherapeutic drug candidates, but these assays have some limitations. Creative Biolabs also offers a one-stop in vivo immunogenicity assessment service, which uses a variety of animal models, including HLA transgenic mice and humanized mice, to provide the most direct assessment of the molecules before entering clinical trials.

Creative Biolabs' SIAT-based in silico services and in vitro screening provide the most comprehensive immunogenicity assessment package, which addresses the challenges of unwanted immune responses throughout the drug development cycle. By managing potential drug immunogenicity at the earliest possible stage, you can save time and money while creating safer and more effective biotherapeutic drugs for the market.

Publication

This publication introduces AblmmPred, a new computational method for predicting the immunogenicity of therapeutic antibodies using features derived from the AntiBERTy pre-trained language model. The goal is to address the time-consuming and costly nature of traditional wet-lab experiments for assessing immunogenicity. AblmmPred was developed by training a machine learning model on a dataset of 199 commercial therapeutic antibodies, using only the amino acid sequences of their variable regions. The method avoids the need for 3D antibody structures, which are required by other methods like PITHA. The results show that AblmmPred outperforms a comparison method, PITHA, with an accuracy of 0.7273 on an independent test dataset, which is 9.09% higher than the comparison method's accuracy. The authors suggest that this new method could help speed up the development of antibody therapeutics.

Fig.1 A step-by-step guide to the AbImmPred.¹

The Creative Biolabs Advantage in Immunogenicity Prediction

Creative Biolabs stands as a leader in immunogenicity prediction due to our two decades of specialized expertise, our integrated multi-platform approach, and a proven track record of de-risking biotherapeutic development. Our unwavering commitment to innovation, evidenced by our pioneering use of cutting-edge AI/ML models, ensures the highest accuracy and most insightful predictions available in the industry. Unlike traditional methods that may rely on cumbersome 3D structural data, our sequence-based, AI-driven approach offers superior efficiency and precision, as demonstrated by published data showing significant performance advantages over existing methods. Our extensive experience allows us to navigate the nuances of immunogenicity, providing tailored solutions that truly impact your project's success.

Ready to experience the Creative Biolabs advantage and accelerate your therapeutic development? Get a Quote Today and let us demonstrate our commitment to your success.

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Complementary Biologic Development Services

To further support and accelerate your biotherapeutic development journey, Creative Biolabs offers a comprehensive suite of complementary services that seamlessly integrate with our immunogenicity prediction offerings:

Contact Us

Our labs are designed to meet the large-scale bioanalysis for your project, and our dedicated biologics team works with you to tailor your assessment strategy to your treatment goals and schedule using a full suite of immunogenicity assessment packages.

To obtain further information, please contact us.

Reference

1. Wang, Hong, et al. "AbImmPred: An immunogenicity prediction method for therapeutic antibodies using AntiBERTy-based sequence features." Plos one 19.2 (2024): e0296737. Distributed under Open Access license CC BY 4.0, without modification. DOI: https://doi.org/10.1371/journal.pone.0296737

For Research Use Only | Not For Clinical Use