Assessment of biomarker stability and assay performance parameters for medical diagnosis: a case study of diagnosis of major depressive disorder.

Aim: Assessing the stability profiles and assay performance of 24 biomarker assays in 32 biomarker/body fluid combinations identified as relevant for prediction of major depressive disorder. Materials & methods: Combinations were tested for stability and assay performance with ELISA at different storage and freeze-thaw conditions in pooled samples of 40 patients. Results: Stability and assay performance issues were found in almost all cases except three biomarkers in urine and three in serum. Conclusion: This study shows that, to produce reliable measurement data, assessments of stability and assay performance are essential. In development, other quality assurance parameters might be implemented to increase the level of measurement reliability by increasing assay performance control.

Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum.

Flow cytometry is a powerful tool that can be used for the support of (pre)clinical studies. Although various white papers are available that describe the set-up and validation of the instrumentation (the flow cytometer) and validation of flow cytometry methods, to date no guidelines exist that address the requirements for performing flow cytometry in a regulated environment. In this manuscript, the European Bioanalysis Forum presents additional practice guidance on the use of flow cytometry in the support of drug development programs and addresses areas that are not covered in the previous publications. The concepts presented here are based on the consensus of discussions in the European Bioanalysis Forum Topic Team 32, in meetings in Barcelona, Limelette and multiple telephone conferences.

8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.

The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation--The 2013 Revised FDA Guidance. This GCC meeting was organized to discuss the contents of the draft revised FDA Guidance on bioanalytical method validation that was published in September 2013 and consolidate the feedback of the GCC members. In attendance were 63 senior-level participants, from seven countries, representing 46 bioanalytical CRO companies/sites. This event represented a unique opportunity for CRO bioanalytical experts to share their opinions and concerns regarding the draft FDA Guidance, and to build unified comments to be provided to the FDA.