CPSA 2011

Science and Technology Coming Together to Make a Difference

October 3 - 6, 2011
Bucks County Sheraton Hotel
Langhorne, PA

Program Abstract

Wednesday, Lunch & Learn Session

Transitioning Qual/Quant Platforms from Small Molecules to Biologics

Matt Willetts
Senior Applications Scientist
Bruker Daltonics

By 2014 it is expected that six of the top world's top ten best selling drugs will be biopharmaceuticals. The characterization of these products presents many challenges due to their high molecular weight, the heterogeneous nature of proteins, and the complexity of the production process. Subtle changes in the manufacturing steps can introduce unexpected and unwanted modifications to the product. Therefore, a solution is required for fast, reliable, and quantitative characterization of biopharmaceuticals in a high throughput, automated manner. Fortunately, many of the tools used in classical small molecule Qual/Quant workflows are applicable to biopharmaceutical analysis. In this workshop we will describe methods based on LC-MS technology to provide complete automation of the characterization workflow. These methods combine ultra high-resolution chromatography (U-HPLC), ultra high-resolution mass spectrometry (UHR-TOF-MS), and a newly developed software—BioPharma Compass.

Biopharma Compass is a fully automated software solution for the rapid characterization of biopharmaceutical products such as proteins, peptides, RNA and DNA. LC & MS data are acquired, processed, compared with reference standards and are reported in a completely automated fashion at the touch of a button. Results are very visual—allowing important information to be detected at a glance. A 96 well traffic light system provides instant verification that a product meets specific user defined criteria. Detailed reports show TICs, deconvoluted intact masses, mass shifts, impurities and quantitative differences in glycosylation profiles compared to standards. At the peptide level, protein sequence coverage charts and base BPC annotation provide an overview at the MS and MSMS level of detected peptides including any modifications.

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