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Bioanalysis and Biomarker Services That Support Every Drug Development Phase

With more than l00 years of combined industry experience of our leadership team and three GLP compliant laboratories, we are ready for all your current and emerging bioanalytical needs.

lmmunoassays Protein/oligonucleotide therapy, biomarkers and anti-drug antibodies utilizing multiplex and ultrasensitive ELISA, MSD, Gyrolab, Luminex, and SPX LCMS Antibody-drug conjugates (ADC), oligonucleotide, peptide, small molecule and biomarkers utilizing HR and triple quad MS Cell-based Assays Neutralizing anti-drug antibody and activity-based biomarkers Flow Cytometry Cell therapy and biomarker (e.g. immunophenotyping and receptor occupancy assays) ELISpot Assays Vaccine efficacy and characterization of cell-mediated immune response Molecular Biology Cell/gene therapy, RNA vaccines, gene editing therapy and biomarkers utilizing qPCR, ddPCR, RNA-Seq, NanoString, and NGS

How Can We Help?

We thrive on developing bioanalytical solutions that require out-of-the-box thinking. Our full service approach covers everything you need to take your program to the next stage — delivered with a personal and consultative focus.

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Informed Bioanalysis of Biomarkers

We perform in-house GLP and GcLP sample analysis with optimized methods targeted to your compound needs. To ensure that biomarkers are decision-making for drug development, we deliver not only method and data, but also strategy and data interpretation in collaboration with our clinical research and PKPD modeling teams.

 

 

CustomizedAssay_551x402@2x Comprehensive Immunogenicity Assessment to Support Drug Approval We provide comprehensive solutions, including:

  • Immunogenicity risk assessment and clinical immunogenicity strategy
  • Assay development/validation
  • Sample testing (anti-drug antibody screening, confirmation, titration, neutralization capacity, domain specificity, isotyping)
  • Data analysis in the clinical setting (effect of anti-drug antibody on pharmacokinetics/pharmacodynamics, efficacy and adverse reactions)
  • Regulatory submission documentation (e.g., integrated summary of immunogenicity, 2.7.1, 2.7.2, CSR etc.).
 Untitled design (9) (1)-1 Customized Assay Development Our bioanalysis and biomarker labs support assay development and validation strategies with a wide range of cutting-edge technologies, and best-in-class tools and solutions. Unlike other analysis services, our team of experts create fit-for-purpose solutions that achieve your objectives, assess critical reagent needs, and recommend the best approach for reagent selection. Untitled design (4) (1) Several Steps Ahead Because our extensive knowledge of drug development and broad technical expertise, we can transfer complex assay methods or perform assay development. We can do complete assay development and validation, create the report, and define sample analysis plans for preclinical and clinical study phases. We do it in-house with our seasoned experts. Follow our scientific communications and seminars to see how Amador Bioscience can change your drug development process.

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