Screening Non-neutralizing Anti-idiotype Antibodies Against a Drug Candidate for Total Pharmacokinetic and Target Engagement Assay.

Non-neutralizing anti-idiotype antibodies against a therapeutic monoclonal antibody (mAb) play a crucial role in the creation of total pharmacokinetic (PK) assays and total target engagement (TE) assays during both pre-clinical and clinical development. The development of these anti-idiotype antibodies is challenging. In this study, we utilized a hybridoma platform to produce a variety of anti-idiotype antibodies against GSK2857914, a humanized IgG1 anti-BCMA monoclonal antibody.

Overcoming challenges associated with the bioanalysis of an ester prodrug and its active acid metabolite.

Bioanalysis of ester prodrugs represents a great analytical challenge due to poor matrix stability in the presence of esterases. Materials & methods: An approach that includes pH control, temperature and the use of an inhibitor (sodium fluoride, NaF) was employed for complete stabilization of an ester prodrug and its corresponding acid metabolite. Stability information was used to design a methodology with negligible ex vivo hydrolysis of the ester to the corresponding acid analyte during all critical parts of bioanalysis.

GlaxoSmithKline's experience of incurred sample reanalysis for dried blood spot samples.

Dried blood spots are becoming a popular alternative to plasma for many different applications. This has been driven by animal ethics but also by ease of use and cost savings. Recent regulatory guidance now has a requirement for incurred sample reanalysis.