Bioanalysis of novel antibody constructs: approaches and challenges
With increasing complexity of protein therapeutics there is corresponding escalation of effort required to develop and validate bioanalytical assays to support quantification of pharmacokinetic endpoints.
This may include multiple assays to try and understand the catabolism or molecular integrity of these therapeutics; antibody drug conjugates (ADCs) for example may require 3 or more assays to support sample analysis in a single matrix.
This presentation discusses some of the challenges and approaches faced when supporting bioanalysis of antibody therapeutics, including GSK specific case studies for bispecific and ADC platforms.
Speakers
Ka
rolina Österlund
Manager Field Application Scientist EU and Asia
Gyros AB
Karolina Österlund joined Gyros in 2003, working on MALDI-MS applications and then immunoassays using Bioaffy CDs. She has been providing technical support for the Gyrolab immunoassay platform in clinical and bioprocess development for eight years and was instrumental in establishing the technology in North America and Europe. Her experience covers applications for pharmacokinetics, immunogenicity testing, biomarker monitoring, impurity testing and product quantification for therapeutic protein development, in both regulated and non-regulated environments. Karolina currently manages the Gyros European field application scientists as well as provides technical support to the efforts of Gyros Asia Pacific distributors. Karolina is involved in working groups such as the Global Bioanalysis Consortium, and the 21st Century Bioanalytical Initiative. She earned her M.Sc. in Chemical Engineering from Uppsala University, Sweden.
Lee A
bberley
Section Manager
GlaxoSmithKline
Lee Abberley is currently a Section Manager in the bioanalysis DMPK group at GSK, King of Prussia with responsibility for managing small and large molecule non and regulated bioanalytical support. PhD in Pharmaceutical Sciences from the University of Nottingham, UK. Worked at GlaxoSmithKline for 10 years, originally in the UK working in a DMPK group within the Neurosciences therapeutic area. Undertaken a lot of work on the Gyrolab platform to develop methods to support biopharmaceutical assets.