- 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
- 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
