Immunogenicity testing-MAPPs

Get deep insights into the immunogenic profiles of your biotherapeutic.

IMMUNESPEC

Unlock the Full Immunogenic Profile
of Your Biotherapeutics
 

Biotherapeutics can provoke unwanted immunogenicity, significantly impacting drug efficacy and potentially leading to severe adverse events that compromise patient safety. Regulatory agencies, including the FDA and EMA, emphasize the need for structured immunogenicity risk assessments throughout drug development. Addressing immunogenicity early is crucial to avoiding costly late-stage failures and ensuring therapeutic success.

To meet these requirements—and to prevent advancing too far with a drug that elicits unwanted immunogenicity, reduced efficacy, and ultimately leads to costly failures—incorporating MHC-Associated Peptide Proteomics (MAPPs) early in development helps reduce risk, optimize drug efficacy, and improve clinical outcomes.

MAPPs

The gold standard early in immunogenicity risk assessment studies 

The MAPPs assay offers direct experimental insights by identifying naturally processed and MHC-presented peptides from in vitro antigen presentation. MAPPs is the only assay that provides direct identification of MHC-presented peptides, offering experimental confirmation of naturally processed and displayed epitopes.

Immunogenicity is not solely determined by linear sequence; it is influenced by how antigens are processed and presented. The MAPPs assay delivers a comprehensive model for in vivo antigen presentation, covering protein uptake, processing, and peptide presentation by MHC molecules.

MAPPs provides insights into the abundance of presented peptides derived from specific regions and offers a lower false positive rate compared to in silico prediction tools. While computational approaches remain valuable, our results demonstrate that integrating experimental MAPPs data with predictive models yields a more comprehensive and reliable assessment of immunogenicity risk.

In addition to identifying naturally presented peptides, MAPPs also provides insights into (post-translational) modifications that may influence antigen processing, presentation, and immune recognition.

By integrating the MAPPs assay early in the development of a biotherapeutic, you gain precise insights into putative immunogenic regions. These peptides can then be further assessed in an in vitro peptide assay to determine immunodominant epitopes.

With a full immunogenic profile, MAPPs supports rational de-immunization strategies, optimizes drug design, and helps prioritize the most promising candidates for further development—accelerating the path to safer, more effective therapies.

IMMUNESPEC

Your Trusted Partner in MAPPs Immunogenicity Assessment 

At ImmuneSpec, we are committed to provide the most comprehensive insights from the MAPPs immunogenicity assessment. Our state-of-the-art immunopeptidomics platform delivers high-throughput, highly sensitive analysis, ensuring the most precise and reliable assessment of antigen presentation available today. Our MAPPs assay offers direct experimental insights by identifying naturally processed and MHC-presented peptides from in vitro antigen presentation, allowing drug developers to: 

  • Select the best candidates early in discovery 
  • Optimize drug design to minimize immunogenicity risk  rational de-immunization strategies and helps prioritize the most promising candidates. 
  • Make informed, data-backed decisions to prevent costly late-stage failures

Our offer

  • Don’t miss a T cell epitope – The sensitivity of the MAPPs assay is crucial for obtaining accurate insights into the immunogenic potential of a biotherapeutic. ImmuneSpec’s MAPPs platform is designed to detect even low-abundance presented peptides, minimizing the risk of missing potential T cell epitopes. Our assay consistently identifies a greater number of immunopeptides – both self and non-self – compared to what is typically reported in the literature, ensuring a more comprehensive immunogenicity assessment.
  • Our workflow is optimized for maximized coverage of the full repertoire of MHC-associated peptides in a sample and facilitates identification of all MHC class I peptides (HLA-A/B/C) and/or MHC class II (HLA-DR/DP/DQ) associated peptides, as well as specific HLA allotypes, delivering unparalleled depth in immunopeptidomics analysis
  • Our high-sensitivity MAPPs results are correlated with observed clinical immunogenicity. This relationship highlights the predictive power of our MAPPs assay for assessing the immunogenicity risk of biotherapeutics.
  • We can work with antigen-presenting cells loaded by our customers, enabling the generation of MAPPs data that seamlessly integrates with in-house immunogenicity data. Using the same donor samples and workflow, this approach provides complementary experimental insights to strengthen your immunogenicity assessment.
  • We collaborate with leading partners who specialize in generating loaded cells for the MAPPs assay. These experts carefully select primary cells from a diverse pool of HLA-typed donors to ensure optimal coverage of the target population. They efficiently load your biotherapeutic of interest into professional antigen-presenting cells and, if required, can conduct follow-up studies using the same donor cohort or an extended panel for further studies, such as in vitro confirmation and analysis of immunodominant epitopes.
  • Novel biotherapeutics may be modified with conjugated polymers (e.g., PEGylation, lipid side chains) that are not detected in a standard MAPPs assay. We can adapt our analytical settings to identify presented peptides with modified residues, ensuring accurate data interpretation.
  • By using advanced data analysis, we provide a comprehensive overview of all identified peptides and deconvolute peptide-HLA associations to assign them to specific HLA allotypes in donor cells, ensuring a full insight into the immunogenicity profile of your biotherapeutic. 

HOW DO WE WORK

From intake to report in just 4 weeks

4 WEEKS

Project Initiation meeting

Before starting the project, a kick-off meeting is scheduled between the project team and the client to ensure alignment on the study setup. This step ensures  delivery of optimal results and effectively addressing the research question

Receipt of Input Samples and Sequence Information

After providing guidance on sample collection requirements, samples (tissue/cells) can be sent to ImmuneSpec or sourced through one of our affiliated partners. Where relevant, project-specific sequence databases are shared

Immunopeptidomics Analysis

MHC presented peptides are affinity purified and identified by highly sensitive MS analysis using our advanced immunopeptidomics platform technology. 

MAPPs Results Delivery

For all MAPPS and discovery projects, the overview of identified target peptides is shared with clients upon completion of data analysis, ensuring a comprehensive understanding of the data and providing access to identified target peptides as soon as possible. 

Report Delivery

A detailed report is provided, including an overview of the experiments, the number of identified peptides per sample, quality control data, and graphical representations of identified peptides for target sequences

Project Delivery

A project delivery meeting is scheduled for the ImmuneSpec team to present the overview of the study and obtained data. This session provides clients the opportunity to ask questions, ensuring a clear understanding. The written report can be refined based on discussions from this meeting

Ready to start your Immunogenicity testing-MAPPS journey?