2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

FDA 2011 Process Validation Guidance: Process Validation Revisited

Background In January 2011, FDA announced the availability of a final guidance for industry entitled Process Validation: General Principles and Practices (the 2011 Guidance). The 2011 Guidance revises and replaces FDA’s Guidance for industry entitled Guideline on General Principles of Process Validation, issued in May 1987 (the 1987 Guideline). The 2011 Guidance defines process validation as “t...

TDM Roundtable Recommendations: (Generic) Assay Validation Guidance

TDM Roundtable Recommendations: Lamotrigine Assay Validation Guidance

2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV): (Part 2 - Hybrid LBA/LCMS and input from regulatory agencies).

The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place in Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations, and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event - A Full Immersion Week of Bioanalysis including Biomarkers and ...

Validation and quality control of immunophenotyping in clinical flow cytometry.

Clinical flow cytometry has evolved from two-parameter quantitative assessment of peripheral blood lymphocytes to six-parameter qualitative evaluation of bone marrow for hematopathology. Leukemia and lymphoma immunophenotyping represent an extremely important complement to morphology in the diagnosis and monitoring of hematopoietic malignancies. The complexity of five- and six-parameter analyse...