Biotherapeutic Characterization

Protea brings your project the instrumentation and techniques to help you explore and develop cutting-edge protein and large molecule theraputics.

Characterization of therapeutic proteins and biosimilars provides an incredible value to your investigations focused on novel biotherapeutics, such as monoclonal antibody based agents. Mass spectrometry based determination of higher order structure, conformation, and proper folding of proteins and biosimilars is a necessary component in describing the critical relationship between structure, function and overall efficacy of biotherapeutics. If you are investigating this class of compounds, it is essential to accurately identify, and in some cases quantify, variability of structural differences in biotherapeutics between process lots.

Our team uses an integrated approach for the analysis of protein therapeutics:

• Core shell based HPLC separation (Protea Amplus®) of proteins and intact mass analysis using our Waters SYNAPT® G2-S HDMS for high resolution mass spectrometry
• Enzymatic digestion and LC-MS/MS protein characterization
• Identification of post-translational modifications
• Protein phosphorylation site mapping
• Protein glycosylation site mapping
• Characterization of process impurities such as protein truncation or mutation
• Mapping of disulfide bridges and scrambled disulfide bridges for characterization of protein folding
• For absolute quantitation of protein therapeutics and process impurities, targeted multiple reaction monitoring (MRM) assays can be developed based on characterization studies using our AB Sciex 5500 QTRAP® mass spectrometers.
• Fit-for-Purpose (FFP) assay validation and sample analysis

Our methods have been developed to tackle your most challenging projects. Using your input, our interdisciplinary scientific team designs efficient strategies for sample preparation and analysis. By taking advantage of our state-of-the-art facilities, instrumentation, and scientific proficiencies, we can lower the financial risk of your biotherapeutic characterization studies.

Case Studies and App Notes:
CASE STUDY: Direct Characterization of Cysteine Binding in Signal Transduction Pathways by LC MS-MS	Label-Free Quantitation of Proteins in Human Prostate Cancer Patient Plasma	CASE STUDY: Biomarker Discovery in Human Prostate Cancer Patient Samples Using Combined MuDPIT and BIOiTRAQ Workflows