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Services

Bioanalysis

(Pharmacokinetics, Immunogenicity, & Biomarkers)

 

Combining Scientific Excellence with Creative Innovation 

As a leading clinical development laboratory, we bring a rich history of success supporting biomarker-focused programs, by combining innovative study approaches with a broad range of industry-leading technologies. We offer broad expertise in multi-omic biomarker analysis methods that enable us to overcome complex clinical study challenges to provide the robust bioassay data our biopharma clients need to further their development programs.

 

Viracor offers a wide range of immunoassay technologies, including: enzyme-linked immunosorbent assay (ELISA), Electrochemiluminescence (MSD); as well as molecular (qPCR), genomics (Sanger & NextGen sequencing), and cell-based assays. We employ advanced platforms such as ELISpot, flow cytometry, digital drop PCR, ImmunoCAP, Luminex® and MSD®-ECL, together with our live cell handling capabilities (PBMC isolation, cell culture, etc.) and our scientific staff of experts.

 

Immune Response & Monitoring

Whether assisting clients in achieving compliance with regulatory requirements or in evaluating testing to aid with subject stratification, our extensive menu of more than 2800 assays distinguishes Viracor as your ideal partner. Employing advanced platforms such as ELISpot, flow cytometry, ImmunoCAP, Luminex® and MSD®-ECL together with our live cell handling capabilities (PBMC isolation, cell culture, etc.) and experienced scientific staff, Viracor has developed and supported clinical trials testing with a wide variety of immunoassays and cell-based functional assays.

 

Immunogenicity

The BioPharma industry continues to be challenged by the development, application and interpretation of immunogenicity assays. The FDA has advocated a more stringent approach for cut point setting and assay validation creating further difficulties. Moreover, the industry remains uncertain about when the more challenging neutralizing antibody (NAb) assays should be applied and which type of assay is reliable and acceptable. Additional ongoing challenges concern managing drug and target interference, understanding and handling the impact of pre-existing antibodies, and interpreting the clinical significance of assay data.

Example Immunogenicity capabilities for clinical studies:

  • Immunoassays (ELISA, MSD, Luminex) to measure cytokines and ADAs,
  • CAR T-cell detection and quantification by flow cytometry in PBMC samples
  • Enzyme-linked Immunospot (ELISPOT) analysis for characterizing specific T- or B-cell responses.
  • Gene expression analysis performed by quantitative polymerase chain reaction (qPCR).
  • Multi-color flow cytometry for lymphocyte differentiation, and analysis of intracellular biomarkers (i.e., cytokines, etc.)
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