Learn how our physiochemical-based approach enables us to accelerate the development of bioanalytical assays for insulin analogues from Michael Blackburn, Head of Bioanalytical Method Development and Labs.
Insulin analogues, along with other large peptides, such as GLP-1 receptor agonists, represent a major and growing class of biotherapeutics. Their quantification plays an important part in improving the outcome of downstream formulation development and clinical study activities. However, there are sensitivity challenges when trying to measure trace levels of these types of compounds which require advanced technologies such as LC-MS.
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In this presentation, Michael Blackburn, Head of Method Development and Labs, will describe the bioanalytical strategy that Quotient Sciences employs to best support clinical trials for these compounds and how our physiochemical-based approach enables us to accelerate the development of bioanalytical assays for insulin analogues.
Through case studies, our speaker will touch on some of the pitfalls and solutions that our team of experts have encountered in this field and share what scientists should be aware of when interpreting how LC-MS data correlates with immunoassay data. Using assay validation data, we will cover high-throughput sample analysis and the potential impact of anti-drug antibody effects.
Key Discussion Topics
- How a physiochemical-based approach allows for enhanced specificity and ease of multiplexing, with no requirement for a specific antibody.
- Key considerations that scientists must be aware of in order to meet the demanding requirements for high-throughput analysis of insulin by LC–MS.
- The important role that advanced LC-MS technology plays
- LC-MS vs Immunoassay Data and considerations around free or total peptides
- Bioanalytical assay acceptance criteria & antidrug antibody effects during drug development
Bioanalytical expertise at all stages of drug development
At Quotient Sciences, we are experts in the development, validation, and application of bioanalytical assays. Our dedicated team of bioanalytical chemists are globally recognized and has over 40 years of experience in supporting all stages of drug development, from early pre-clinical, through to first-in-human (FIH), and onwards to Phase II and III patient studies.