Accelerating PK and ADA bioanalytical assay development
Tuesday 25 February 2025
09:00 [PST] 12:00 [EST] 17:00 [GMT]
Accelerating PK and ADA bioanalytical assay development by maximizing dynamic range and adopting generic and streamlined strategies.
This webinar presents advancements in preclinical bioanalytical pharmacokinetic (PK) and anti-drug antibody (ADA) assay development for monoclonal antibody (mAb) therapeutics using the Gyrolab automated immunoassay platform through two case studies. The first case study looks at the development of a generic, plug-and-play ADA assay for cynomolgus monkey studies, highlighting the wide dynamic range to enable signal-to-noise ratio (S/N) reporting and improved drug tolerance over traditional ELISA methods. The second covers PK determination in human serum and cerebrospinal fluid (CSF) utilizing different Gyrolab Bioaffy CDs, allowing optimization of sensitivity and dynamic range with minimal assay development time when transitioning from serum to CSF assays.
What will you learn?
- How to dramatically minimize assay development time for preclinical ADA and PK assessment of therapeutic mAbs
- Streamlining PK and ADA analysis using wide dynamic ranges and increased drug tolerance of microfluidic vs ELISA assays
- Approaches to optimize and automate PK assays of mAbs in CSF with low sample volume constraints in microfluidic formats
Who this may interest?
- Bioanalytical Scientists, Group Leaders and Directors who develop and implement PK/TK and ADA assays in preclinical and clinical development in pharmaceutical and biotech companies
- Analytical Scientists utilizing LC–MS, ELISA or other plate-based assays to measure mAb-based biotherapeutics in biological fluids (serum, plasma, urine, ocular fluid, CSF)
- Automation Engineers responsible for developing and implementing assays in drug discovery and development
- Scientists and Business Development personnel in Contract Research Organizations responsible for choosing bioanalytical platforms for preclinical bioanalysis
Speaker
Alejandro Rodriguez
Principal Scientist
Genentech (CA, USA)
Alejandro Rodriguez is a Principal Scientist at Genentech in the Bioanalytical Sciences Department. His work is focused on developing novel biotherapeutics in immunology therapeutic areas and accelerating and streamlining bioanalytical assay development for large molecule therapeutics. Alejandro obtained his PhD in Chemistry at the University of California Santa Cruz (CA, USA), where he studied amyloid β aggregation and neurotoxicity through biochemical, biophysical, and biological approaches.
Maria Germana Sanna
Field Application Scientist
Gyros Protein Technologies (Uppsala, Sweden)
Maria Germana Sanna is currently a Field Application Scientist at Gyros Protein Technologies. She has been with the company since 2018 and prior to joining the company she was a Staff Scientist/Senior Staff Scientist in the departments of Immunology, Chemical Physiology and Molecular Medicine at The Scripps Research Institute (TSRI). Germana received her PhD in Microbiology and Epidemiology from the University of La Sapienza in Rome (Italy) and completed her postdoctoral fellowship at the California Institute of Technology (CA, USA) before joining TSRI. During her scientific career, she has worked in several major scientific fields including infectious diseases, signal transduction, immunology, autoimmune diseases and pharmacology. This experience has made the transition to exploring the ways immunoassay technologies can be applied to problems in bioanalysis and biotherapeutic drug development an easy progression of her interests and career.
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