Publications
Biosimilars: what clinicians should know
Weise M et al. Blood. 2012;120:5111-7. Abstract Biosimilar medicinal products (biosimilars) have become a reality in the European Union and will soon be available in the…
Setting the stage for biosimilar monoclonal antibodies
Schneider CK et al. Setting the stage for biosimilar monoclonal antibodies. Nature Biotech. 2012;30:1179-85. Abstract With the first marketing authorization application for a biosimilar monoclonal…
6th GCC Focus on LBA: Critical Reagents, Positive Controls and Reference Standards; Specificity for Endogenous Compounds; Biomarkers; Biosimilars
Abstract The 6th Global CRO Council for Bioanalysis (GCC) Closed Forum was held on 27 March 2012 in San Antonio, TX, USA, the day before…
Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Abstract The 6th Global CRO Council for Bioanalysis (GCC) Closed Forum was held on 27 March 2012 in San Antonio, TX, USA, the day before…
Recommendations on biomarker bioanalytical method validation by GCC
Abstract The 5th GCC in Barcelona (Spain) and 6th GCC in San Antonio (TX, USA) events provided a unique opportunity for CRO leaders to openly…
Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development
Abstract Imminent patent expiry for a number of biological products currently on the market (many of which are blockbusters) has created an increasing opportunity for…
Recommendations on the Interpretation of the New European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
Abstract Senior representatives of GCC member companies have thoroughly evaluated and discussed the new European Medicines Agency (EMA; July 2011) Guideline on Bioanalytical Method Validation…
Ligand-Binding Assays in the 21st Century Laboratory: Recommendations for an Automated Data Interchange Process
Published by The AAPS Journal Conclusion For end users, effective laboratory data management is critical to an efficient LBA laboratory in the twenty-first century. An…
Ligand Binding Assays: Recommendations for Characterization and Supply of Critical Reagents
Published by The AAPS Journal AbstractCritical reagents are essential components of ligand binding assays (LBAs) and are utilized throughout the process of drug discovery, development,…
Ligand Binding Assays in the 21st Century Laboratory: Automation
Introduction A constant demand in the pharmaceutical industry is to accomplish more with the same or fewer resources. It is generally accepted that a major…