Publications
Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development
Abstract Biopharmaceutical products (biologics) are active drug substances produced by living cells or derived from a living organism (bacteria, yeast, animal or human cell lines).…
Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis
van Schouwenburg PA, Rispens T, Wolbink GJ. Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis. Nat Rev Rheumatol. 2013;9:164-72. Abstract Currently, five anti-TNF biologic agents…
In vitro and in vivo studies of IgG-derived Treg epitopes (Tregitopes) a promising new tool for tolerance induction and treatment of autoimmunity
Cousens LP, et al Scott DW, De Groot AS. In vitro and in vivo studies of IgG-derived Treg epitopes (Tregitopes): a promising new tool for…
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…