Guidance and White Paper


  • Bioanalytical Method Validation
  • Biomarker Qualification – Evidentiary Framework
  • Bispecific Antibody Development Programs
  • Evaluation of Internal Standard Responses During Chromatographic Bioanalysis – Questions and Answers
  • ADA Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection
  • Bioanalytical Method Validation M10 – draft

White Paper

  • 2019 White Paper on Recent Issues in Bioanalysis – Chromatographic Assays
  • 2019 White Paper on Recent Issues in Bioanalysis – FDA ADA Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation
  • 2019 White Paper On Recent Issues in Bioanalysis – FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs
  • Recommendations for classification of commercial LBA kits for biomarkers in drug development from the GCC for bioanalysis
  • 11th Closed Forum – cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation
  • 12th Closed Forum – critical reagents;oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatoryfindings; stability and immunogenicity
  • Recommendations for the Assessment and Management of Pre-existingDrug-Reactive Antibodies During Biotherapeutic Development
  • Drug Target Interference in ADA Assays: Recommendations and Mitigation Strategies