Session: Rapid Fire: Beyond Legacy Therapeutics - Navigating the Path Less Traveled (CE)
Is Hybrid LC-MS/MS Becoming The New Gold Standard? Unique Case Studies Highlighting the Power of Hybrid LCMS – ADCs, MAbs and Other Protein Therapeutics
You will be able to understand what key factors should be considered to help determine the best bioanalytical strategy for protein biotherapeutic bioanalysis. these include understanding what reagents are available, what sensitivity is required, are there unique amino acid changes that may need to be leveraged to differentiate or help translate this assay across species/fluids. We will also cover why hybrid LCMS should be considered as the first or best option in many cases with key example case studies. ○ Universal/Generic Mab assays in pre-clinical species - How these assays can be developed rapidly and quickly deliver high quality data with good precision and accuracy. These assays can follow several Fc peptides as well as CDR specific peptides if desired ○ ADCs - LCMS can be used to look at several parts of the ADC including the ADC, total Ab and "free" payload. The approach to these assays will depend on several factors including types of conjugation, number of conjugation sties and availability of reagents. This case study will show how LCMS was used to develop a single assay for both ADC and total Ab. ○ Protein Biotherapeutics with small changes in sequence, etc. This case study will illustrate how LCMS can help to provide additional information about protein stability by following several parts of the molecule.
Learning Objectives:
To understand the power Hybrid LCMS provides to support biotherapeutics and large molecule biomarkers
To understand what key factors should be considered to help determine the best bioanalytical strategy for protein biotherapeutic bioanalysis
To understand why hybrid LCMS should be considered as the first or best option in many cases
○ Universal/Generic Mab assays in pre-clinical species
○ ADCs
○ Protein Biotherapeutics with small changes in sequence, etc.