Clinical Biomarker & Immunogenicity Services

Frontage provides clinical biomarker and immunogenicity testing services designed to support the unique needs of clinical biotherapeutics development. These services include developing, validating and performing assays for immunogenicity testing and novel clinical biomarkers.

 

Frontage offers:

  • Novel biomarker and large molecule assay development
  • Immunogenicity test services
  • Cell-based assay services
  • Multiplexed
  • Pharmacokinetic (PK) assays for biotherapeutic macromolecules
  • Technical collaboration
  • GLP-compliance

Frontage’s leadership team has over 30 years of experience in clinical testing for major pharmaceutical companies and diagnostic assay development. We have a high percentage of Ph.D. scientists to personally oversee each client’s project and perform assay validations. Our client service and project management are critical elements to keeping our clients at the forefront of development.

 

Immunogenicity Testing

  • Anti-drug antibodies
  • Cell-based neutralization assays
  • GLP-compliant
  • Protocol development

Clinical Biomarker Services

  • Novel biomarker development
  • Technology transfer
  • Commercial assay optimization

Therapeutic Gene Evaluations

  • Pharmacogenomic and molecular biology testing: genotyping, qPCR, RT-PCR

Analytical Platforms

  • ELISA, EIA, Meso Scale Discovery—MSD®
  • Abbott AxSYM®
  • HPLC & UHPLC
  • LC/MS/MS & GC/MS
  • Ultracentrifugation, cell-based

Regulatory Status

  • CLIA certification
  • GLP compliant
  • PA state DOH certification