Explore by Phase

End-to-End Immunogenicity Expertise.​

Where are you in the development process?

Select your current phase of development to explore how immunogenicity considerations evolve across the product lifecycle. From early discovery through regulatory submission and beyond, EpiVax provides end-to-end immunogenicity expertise that helps teams anticipate risk, generate meaningful data, and translate findings into clear development and regulatory strategies. By integrating computational predictions, experimental validation, and expert consulting across the product lifecycle, we help sponsors make informed decisions, strengthen submissions, and maintain confidence in their immunogenicity strategy as programs advance.

  • In Silico Analysis: Evaluates immunogenic potential using EpiVax’s proprietary computational tools.

  • In Vitro Validation: Confirms predictions with laboratory assays.

  • Immunogenicity Consulting: Designed to support biotech companies navigating the complex world of immunogenicity risk strategy.

Phases of Development

Discovery

Preclinical

IND Enabling Activities

Clinical Development

Regulatory Approval & Beyond

Employ early, high throughput liability profiling, enabling candidate prioritization and minimizing immunogenicity from the outset.​

Lead Selection: High-Throughput In Silico Analyses

Filter out high-risk candidates by ranking against known benchmarks, considering mechanism of action, therapeutic modality, target, and patient characteristics, helping teams prioritize the best options for further development.

Lead Optimization: Deimmunization

Identify and mitigate high-risk regions in your lead candidate’s sequence, enabling sequence optimization to reduce immunogenicity risk and focus therapeutic design.

Preventative Risk Reduction: In Vitro Assays

Optionally perform early de-risking using experimental assays to support lead selection, maximizing R&D efficiency and saving downstream resources.

Execute refined candidate and product-related factor risk assessments, supporting optimization and characterization before regulatory submission. Assess safety and immune-mediated liabilities using in vitro immune functional assays.​

Preclinical Testing: Lead Characterization

Conduct detailed assessments of immune and safety liabilities for comprehensive lead candidate profiling, providing data that supports strategic planning and internal decision-making.

Process Development: Understand Host Cell Proteins

Assess the immunogenic potential of contaminant HCPs derived from Chinese Hamster Ovary (CHO), E. coli, and other common or proprietary expression systems, setting clinically relevant thresholds to guide development and manufacturing decisions.

Validation of In Silico Predictions: In Vitro Immunogenicity Assessments

Integrate in vitro immunogenicity analyses to confirm computational predictions and inform downstream development, providing confidence in candidate selection and strengthening data for regulatory interactions.

Regulatory Submission Preparation: IRA / ISI Writing Support

Compile integrated immunogenicity documentation to support regulatory submissions and lifecycle management, providing reliable evidence for grant applications, publications, and fundraising materials.

Leverage early-stage intrinsic and extrinsic risk outputs to develop the Immunogenicity Risk Assessment (IRA) for IND filing, informing bioanalytical and clinical strategy.​

Immunogenicity Risk Assessment: Integrated Candidate Profiling

Combine computational and experimental insights to develop submission-ready IRA documentation, simplifying regulatory strategy and supporting early-stage decision-making.

Bioanalytical & Clinical Strategy: Tailored Monitoring Design

Design assays and clinical monitoring plans for PK, PD, biomarkers, and immunogenicity, focusing on clinically relevant data while reducing unnecessary testing. 

Regulatory Engagement: Submission & Documentation Support

Support global regulatory interactions and author IND-enabling documents to align immunogenicity, bioanalytical, and clinical plans, helping teams plan and communicate strategically. 

Contextualize emerging data, troubleshoot unexpected immunogenicity signals, identify at-risk subgroups, ensuring patient safety and readiness for regulatory interactions throughout clinical phases.

Ongoing Monitoring: Clinical Immunogenicity Analysis

Implement tailored clinical assays and monitoring plans to track ADA responses and immune signals ensuring patient safety while optimizing R&D efficiency.

Risk Assessment: Patient Subgroup Identification

Identify at-risk populations and refine monitoring or mitigation strategies iteratively based on emerging clinical data, maximizing actionable insights from trials.

Translational Data Integration: Reverse Translation

Use clinical findings to improve early development decisions and optimize ongoing trials strategies, supporting strategic planning and internal prioritization.

Prepare a robust Integrated Summary of Immunogenicity (ISI) for regulatory submission and inform post-market strategy (immunogenicity surveillance, comparability assessments for product changes, exploring new indications/patient populations).

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Submission Support: Integrated Summary of Immunogenicity

Develop ISIs integrating preclinical and clinical data to meet regulatory expectations, providing regulators and stakeholders with clear, reliable immunogenicity evidence.

Post-Market Strategy: Surveillance and Comparability Assessments

Monitor immunogenicity post-approval, assess product changes, and support expansion into new indications or patient populations, enabling informed lifecycle management decisions.

 

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