Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars.

The 6th Global CRO Council for Bioanalysis (GCC) Closed Forum was held on 27 March 2012 in San Antonio, TX, USA, the day before the start of the 6th Workshop on Recent Issues in Bioanalysis. The attendance consisted of 45 bioanalytical CRO senior-level representatives on behalf of 37 CRO companies/sites from six countries. In addition to following up on the issue of co-administered drugs stability and on recommendations regarding the European Medicines Agency guideline, this GCC Closed Forum discussed topics of current interest in the bioanalytical field with focus on ligand-binding assays, such as lot changes for critical reagents, positive controls and reference standards, specificity for endogenous compounds, qualification and validation of biomarker assays, approach for biosimilars and criteria for LC–MS assays of small versus large molecules.

[1]  Roger Hayes,et al.  Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC). , 2012, Bioanalysis.

[2]  Stacy Ho,et al.  2011 White paper on recent issues in bioanalysis and regulatory findings from audits and inspections. , 2011, Bioanalysis.

[3]  Binodh DeSilva,et al.  Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules , 2003, Pharmaceutical Research.

[4]  Fabio Garofolo,et al.  Conference report: the 3rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum. , 2011, Bioanalysis.

[5]  Roger Hayes,et al.  Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC). , 2012, Bioanalysis.

[6]  Afshin Safavi,et al.  Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents , 2012, The AAPS Journal.

[7]  Roger Hayes,et al.  4th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA guidelines, 483s and carryover. , 2012, Bioanalysis.

[8]  Vinod P. Shah,et al.  Workshop/conference report—Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays , 2007 .

[9]  Xinping Fang,et al.  Formation of a Global Contract Research Organization Council for Bioanalysis. , 2010, Bioanalysis.

[10]  Roger Hayes,et al.  Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis. , 2011, Bioanalysis.

[11]  Roger Hayes,et al.  Recommendations on biomarker bioanalytical method validation by GCC. , 2012, Bioanalysis.

[12]  Eric Woolf,et al.  2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance. , 2010, Bioanalysis.

[13]  Fabio Garofolo,et al.  Bioanalytical Method Validation , 2004 .