Immunogenicity Assessment

New technique, in combination with the use of artificial intelligence, allows fragments of antibodies to be screened for susceptibility to aggregation caused by structure disruption much earlier in the drug discovery process. Protein/Antibody therapies can be highly effective in treating disease. The failure rate of protein candidates upon manufacturing at industrial scale is a significant problem, emerging in the late stage of development process. With the protein/antibody sequence information gathered into our database and getting bigger, the screening system is underdeveloped using AI methods. Protheragen's AI platform has a range of proteins to screen and to determine which are more likely to progress through the development process.

nomain-drag-pic1Immunogenicity Testing

FDA has announcing the availability of a final guidance for industry entitled “Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection.” Immunogenicity is the intrinsic capacity of a product to induce an immune response in a target population. Immunogenicity testing assays provide a way to measure the potential immune responses of biologics and biosimilars.

Immunogenicity is important for both vaccines and therapeutic proteins.

  • nomain-title-log-pic2 Designed to raise an immune response to provide protection in fighting a disease.
  • nomain-title-log-pic2 Designed to exert a specific therapeutic function (biological activity) ------ Efficacy / Activity
  • nomain-title-log-pic2 Anti-drug antibody (ADA) response to protein drugs may reduce efficacy, compromise the pharmacodynamics and safety, and lead to severe side effects in some cases. ------Toxicity / Safety
nomain-deno-pic2

Figure 1 Potential Causes of Immunogenicity

nomain-deno-pic1In Vitro Bioassays

  • Based on clinical samples (human PBMC bank)
  • nomain-title-log-pic2 Innate immune response

    Whole PBMC/DC activation – impact of proteins and impurities

  • nomain-title-log-pic2 Adaptive immune response

    MAPPs (MHC-Associated Peptide Proteomics)
    T cell activation assays (native and memory)

  • nomain-title-log-pic2 Immunotoxicology

    Impact of mode of action
    Off-target binding

nomain-drag-pic1In silico Services Profile

  • nomain-title-log-pic2 HLA Class I (CD8+) and HLA Class II (CD4+)
  • nomain-title-log-pic2 Global or Caucasian population
  • nomain-title-log-pic2 TCR Filters

nomain-drag-pic1 In silico Tool (T Cell Epitope Prediction)

Epitope Binding Prediction Peptide-MHC Binding Prediction TCR Binding Predictions HLA Binding Predictions

nomain-drag-pic1 Advantages

  • Antibody discovery and screening expertise
  • Leading knowledge of protein structure and aggregation
  • AI-Assisted Antibody Selection platform

Experts from Protheragen are dedicated to helping researchers and pharmaceutical companies to identify patterns in protein sequences, and inform our clients whether a drug can be scaled up for production.

Online Inquiry

Please submit a detailed description of your project. We will provide you with a customized project plan to meet your research requests. You can also send emails directly to inquiry@protheragen.com for inquiries.

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  • Email: inquiry@protheragen.com

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