Our Services

Comprehensive immunogenicity risk assessment support across your research and development lifecycle

A Collaborative Approach

Together we bring complementary expertise in preclinical immunogenicity risk assessment, risk mitigation and clinical immune monitoring. Whether you work with one of us individually or both of us together, you can benefit from our shared knowledge and expansive network within the immunogenicity and biopharma communities.

We tailor our services to meet your specific needs—whether you're advancing a novel biologic through early development, troubleshooting an unexpected immunogenicity signal, or preparing for a critical regulatory submission.

Common Services & Offerings

Discovery to IND Support

Immunogenicity guidance from the earliest stages of discovery through IND submission.

  • In silico immunogenicity prediction results review
  • Drug target, disease and therapeutic modality risk evaluation
  • IND-enabling risk assessment studies design
  • Drafting immunogenicity risk sections of IND

Risk Mitigation Planning

Proactive risk identification with actionable mitigation strategies customized to your specific program's context.

  • Review of target compound and target product profiles
  • Risk factor identification and scoring
  • Mitigation strategy development
  • Clinical context considerations

Program Troubleshooting

Rapid assessment and strategic recommendations for programs facing immunogenicity challenges.

  • Unexpected ADA signal investigation
  • Regulatory response preparation
  • Root cause analysis support
  • Risk-benefit assessment

Clinical Immunogenicity Strategy

Development of comprehensive clinical immunogenicity testing strategies and regulatory-aligned protocols.

  • Clinical ADA testing strategy
  • Sample collection schedule design
  • Integrated summary of immunogenicity (ISI) preparation
  • Clinical impact correlation analysis

Assay Development Guidance & Validation

Technical guidance for nonclinical immunogenicity risk assessment and clinical immune monitoring assays.

  • CRO selection and coordination
  • Nonclinical assay development and validation
  • ADA assay development review
  • Drug tolerance and cut-point guidance

Comparability Assessments

Expert evaluation of immunogenicity implications from process changes, supporting your comparability exercises and regulatory submissions.

  • Manufacturing change impact assessment
  • Biosimilar immunogenicity strategy
  • Critical quality attribute evaluation
  • Regulatory submission support

What We Deliver

Clear, actionable outputs that support your development decisions and regulatory submissions

Reports

Comprehensive immunogenicity risk assessment reports with clear risk scoring, supporting data, and decision-enabling guidance.

Strategy Documents

Preclinical and clinical immunogenicity testing strategies, ADA testing plans, and mitigation roadmaps tailored to your program.

Expert Consultation

Interactive sessions with your development team, regulatory meeting support, and ongoing advisory relationships.

Let's Discuss Your Needs

Every program is unique. Contact us to discuss how we can tailor our services to support your specific immunogenicity risk assessment requirements.

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