While LC-MS avoids common LBA shortcomings, such as cross-reactivity and anti-drug antibody effects, the lack of a single standardized workflow and the multitude of options within a workflow make optimization difficult and time-consuming. Specifically, variability arising from sample preparation is of particular concern when assays are transferred between sites, from sponsor to CRO, or even between labs in the same research, testing or pharmaceutical organization. This workshop will highlight the implementation and benefits of generic, kitted methods used to simplify, streamline and standardize common protein quantification workflows, while reducing variability and delivering accurate and precise results. Data for infliximab, adalimumab, trastuzumab, bevacizumab and the antibody–drug conjugate (ADC) T-DM1 will be shown as working examples. Using this simple kit-based approach and strategies outlined in the workshop, detection limits of as low as 10 ng/mL are achieved from only 35 mL plasma. At the same time, single digit accuracy and precision are reported for the range of proteins tested. Furthermore, this ADC-friendly method and kit was successfully used to perform total antibody quantification on T-DM1. These generic, yet fully optimized and standardized workflows enable novice and experienced scientists alike to perform robust protein quantification easily and routinely.
What will you learn?
- The benefits of a standardized approach to protein bioanalysis
- How to implement a generic kitted approach and facilitate robust lab to lab method transfer
- Novices will learn the key elements of protein quantification and how to routinely obtain optimal results
Who may this interest?
- Lab directors and lab managers
- Method development scientists
- Bioanalytical scientists
- Scientists looking to start or simplify protein quantification
Erin Chambers, currently Director of the Technology Advancement Group and a principal scientist at Waters Corporation, has been in the bioanalysis field for over 20 years, and at Waters for almost 15. She started her career at Pfizer supporting DMPK and has also worked as an MS service engineer and in instrument development for Applied Biosystems. In her current role, Erin develops bioanalytical applications for large and small molecule therapeutic and endogenous compounds. In addition, she has responsibility for assessing new sample preparation, LC and MS products as well as providing both in-house and customer training. Her most recent focus has been on the bioanalysis of proteins and peptides. Erin has authored numerous papers and a book chapter on this topic. Her current research interests include Alzheimer’s disease and diabetes.
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