Industry Insights
Webinar Recording: Clinical relevance of (unwanted drug-induced) immune responses
Ultimately, all biological drugs are immunogenic. Over the last several years, methods for the detection of drug-induced antibodies have become more sensitive, which means that…
Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study
Abstract A panel of 9 fully human monoclonal antibodies against human erythropoietin (EPO) with defined characteristics (non-neutralizing, neutralizing, various isotypes, affinities) representative of those evident…
Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein
Curtin F, Perron H, Kromminga A, Porchet H, Lang AB. Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral…
Recommendations on incurred sample stability (ISS) by GCC
Abstract The topic of incurred sample stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part…
Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway
Chamberlain P. Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway.…
2013 White Paper on recent issues in bioanalysis: ‘hybrid’–the best of LBA and LCMS
Abstract The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and…
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…
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…
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…