Automated Pharmacokinetic Bioanalysis at Nanoliter-Scale: From Early Stage Development to Validation and Transfer for Clinical Studies

January 30, 2013
11:00 am – 12:30 pm EST

Sponsored by
 

Symposium Course Description: Phamacokinetic (PK) bioanalysis presents challenges at all stages of development for the safety and efficacy of biologics. Early in development, there is a need to support multiple candidates and multiple programs. In regulated bioanalysis, more robust methods with higher throughput are essential for decisions in advancing project timelines. Application of the Gyros technology platform for PK bioanalysis provides versatility and flexibility at all stages in an automated, nanoliter-scale format. The webinar focuses on the implementation of the Gyrolab workstation for automated PK bioanalysis in support of early stage development, regulated bioanalysis and clinical trials.

Moderator::

Robert Durham, Ph.D., Manager, Field Application Scientists, North America, Gyros, Inc.
Rob.durham@gyros.com 

Presenters::

Implementation of a universal analytical method in early-stage development of human antibody therapeutics: application to pharmacokinetic assessment for candidate selection
Vimal Patel, Senior Associate Scientist, Amgen, Thousand Oaks, CA, USA
vimalp@amgen.com 

Validation of PK Assays Using the Gyrolab Platform to Support Clinical Studies
Jo Goodman, Senior R&D Manager, MedImmune, Cambridge, UK 

Development and Validation of a Pharmacokinetic Assay on the Gyrolab Platform for Use in Phase II/III Clinical Studies
Shawn Fernando, Senior. Researcher, Bioanalytical Development, Morphotek, Exton, PA, USA
sfernando@morphotek.com