The NJ Mass Spectrometry Discussion Group presents its October meeting on Tuesday, October 20, 2015 at at the Holiday Inn Somerset-Bridgewater, 195 Davidson Ave, Somerset NJ 08873
Sponsored by Thermo Fisher Scientific
The evening is free for attendees, courtesy of our sponsor!
Please register here.
5:30 pm Social and registration
6:15 pm Complimentary dinner
7:00 pm Welcome and opening remarks
7:05 pm Speakers
Dr. Guilong Charles Cheng
Team Lead, Product Characterization, Alexion Pharmaceutical, Inc
Detailed Characterization of Therapeutic Proteins on An Orbitrap Platform
ABSTRACT: Therapeutic proteins, including recombinant monoclonal antibodies are inherently heterogeneous, due to various enzymatic and non-enzymatic modifications occurred during different stages of processes from cell culture to storage. N-terminal pyroglutamine cyclization, C-terminal lysine variation, glycation, glycosylation variation, incomplete disulfide bond formation, deamidation and oxidation are just a starting list of modifications commonly found in an antibody. This complexity posts great challenges not only for MS hardware perspective for both sensitivity and dynamic range, but also for the backend data analysis, which has vastly different requirements than the traditional proteomic data analysis approach. This presentation will provide recent examples on the use of an Orbitrap Fusion platform along with PepFinder software to examine the digestion protocols for our mAb, to characterize charged species in the release assay, as well as to understand degradation mechanisms and applications in product comparability.
Joshua J. Nicklay & Keeley M. Murphy
Thermo Fisher Scientific
A High Resolution Accurate Mass Approach for Reliable and Sensitive Quantitation
ABSTRACT: As potential leads for successful drug candidates move through the drug discovery process, there is a need for quantitative in vitro and in vivo analysis at each step. The requirement for quantitative assays that provide accuracy, sensitivity, reproducibility, and broad linear response has remained a constant. As mass spectrometry technology has progressed over time other aspects also play an important role in meeting the needs of these assays. Ease of use, simplified method development and the availability of troubleshooting tools now represent important factors when choosing the most appropriate technology for a particular assay and the corresponding method development. Here we will explore the benefits of a high resolution accurate mass approach for quantitative analysis in regards to ease of use and method development as well as overall assay performance.