Laboratory Sciences

Bioanalytical Sciences

A core capability at Immunologix, providing cutting-edge bioanalytical quantitation (PK) method development, validation and study sample analysis in support of large molecule, cell and gene therapy, and nucleic acid-based biotherapeutics.

Execution

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 ligand binding based programs. Immunologix continues to build on our significant experience in:

  • Optimal assay format selection
  • Assay development and validation
  • Critical Reagent characterization
  • Impeccable regulatory and guidance adherence
  • Execution and delivery of your quantitation data on time
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Our Bioanalytical Process

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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 structure, target, and matrix
  • Focus on the most clinically-relevant aspects of assay
  • Optimization of format, reagents, range, and sensitivity
  • Systematic transfer from Development to Validation
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Ligand Binding Based Quantitation Assay Formats

  • Drug target capture
  • Anti-drug idiotypic antibody capture
  • Double antibody sandwich assay
  • ELISA and ECL platforms
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Validation

  • Performance Evaluation to assure successful validation
  • Performance characteristics meet regulatory requirements
  • Validation Plans aligned with regulatory guidelines
  • Qualification of minimum 2 scientists during validation

Instruments used in Bioanalytical Sciences

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Perkin Elmer plate readers

Perkin Elmer plate readers

Primary ELISA platform.  Majority of assays,  Multiple units for redundancy

MSD Sector 600

MSD Sector 600

Industry-standard Electrochemiluminescence platform. Proven, Rugged, 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

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