Laboratory Sciences

Immunogenicity

Immunogenicity risk assessments and associated immunogenicity assay strategies to support your molecule from late research to post-approval. Your project team - Principal Investigator, Assay Development Scientist, and Translational Scientist, provide strategic input and ensure that our assays are designed to optimally support your clinical context.

Relevance

Our Science and Services

Immunologix has significant expertise in quantitation assays for a wide range of therapeutic modalities.. Our scientists and principal Investigators have demonstrated experience and proficiency with LBA programs. Immunologix continues to build on our significant experience in:

  • Bridging and direct binding based assays
  • Ligand binding based neutralization assays
  • Isotyping assays
  • Supporting confirmation assays
  • Anti-PEG assessment
  • Pre-clinical and clinical studies
  • Biosimilar studies
  • In study cut point assessment
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Our Immunogenicity Expertise

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Dedicated LBA Laboratory

  • Critical Reagent characterization
  • Consistent, thorough Method Development process
  • Performance characteristics meet/exceed regulatory requirements
  • Performance Evaluation assures successful  Assay Validation
  • Sample Analysis for Pre-clinical and Clinical studies
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Method Development

  • Translational Sciences integration and planning
  • Customized for your molecule and mechanism of action
  • Focus on the most clinically-relevant aspects of assay
  • Optimization of format, reagents, MRD, drug tolerance, Positive Control 
  • Preliminary cut point assessment and performance evaluation
  • Systematic transfer from Development to Validation
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Ligand Binding Based Quantitation Assay Formats

  • Custom drug labeling
  • PC characterization
  • Optimal MRD and drug tolerance
  • ACE and SPEAD adapted methods
  • ELISA, ECL, and Flow Cytometry platforms
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Validation

  • Performance Evaluation to assure successful validation
  • Validation Plans aligned with regulatory guidelines
  • Qualification of minimum 2 scientists during validation
  • Balanced design
  • Cut point setting

Instruments used in immunogenicity

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MSD Sector 600

MSD Sector 600

Primary ADA platform.  Industry-standard Electrochemiluminescence platform. Proven, Rugged, Multiple units for redundancy

Perkin Elmer plate readers

Perkin Elmer plate readers

Primary ELISA platform.,  Multiple units for redundancy

Protein Simple Ella

Protein Simple Ella

Optional approach to standard ELISA for specific therapeutics or assay requirements. Multiple units for redundancy

Therapeutic modalities

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    Monoclonal Antibodies
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    Bi-Specific, Tri-Specific Fusion Proteins
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    PEGylated molecules
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    Peptides
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    Biosimilars
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    Exosomes
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    Transgene proteins
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    AAV Vectors

Talk To A Scientist

Get started on your project today.