Attend Chimera Biotecs presentations on:
Ultra sensitive PK Bioanalysis in Development of a Bispecific Immune-Recruiting Biotherapeutic
Time: Monday, November 5th 3.30pm
Location: 151 A, Walter E. Washington Convention Center
T cell-based therapies have been associated with TOX profiles, which need to be carefully managed and based on their high potency, initial dosing is very low in clinical trials. In consequence, the expected drug concentrations in PK profiling are well below the technical limitations of conventional ELISA-type ligand-binding assay (LBA) support. The challenge to overcome was the extreme low dosing during first-in-human studies of a highly potent T-cell recruiting bispecific tetravalent antibody for the treatment of hematological malignancies.
In this presentation we discuss assay development and method validation for support of an ultra-sensitive PK assay for GCP regulated bioanalytical sample testing support.
Glycogen Synthase as Biomarker for Neurodegenerative Lafora Disease
Time: Tuesday, November 6th 3.30pm
Location: 146 C Walter E. Washington Convention Center
Lafora disease is a currently incurable, fatal glycogen metabolism disorder and neurodegenerative disease, affecting neuronal, liver, skin, heart and muscle cells in human. Symptoms begin in late childhood with epileptic seizures and include muscle spasms, difficulty walking, and dementia. Patients experience rapid cognitive deterioration and the disease is often fatal within 10 years of onset casing death before the age of twenty-five. This presentation discusses Glycogen Synthase as prognostic biomarker for Lafora disease by bioanalytical sample testing in CSF from healthy and diseased children with the challenge to provide the needed sensitivity at minimized CSF sample volume from growing children.