Multiple Analytical Workflows for Protein Biotherapeutics Characterization
Monoclonal antibodies (mAbs) and their derivative products are a very important class of biopharmaceutical molecules. mAbs are tetrameric glycoproteins having a molecular mass of approximately 150 kDa, composed of two heavy chains and two light chains, inter-linked by several disulfide bonds, and having at least one conserved N-glycosylation site located in the Fc domain. mAbs were introduced for the treatment of various diseases in the late 1980 and they still represent the most rapidly growing category of therapeutic molecules today. There are more than one hundred mAbs approved by the US Food and Drug Administration (FDA). mAb are particularly interesting because of their good therapeutic efficiency, favorable pharmacokinetic (PK) and pharmacodynamics (PD), and relatively low side-effects.
We present various workflows here for characterization of mAbs:
- Intact Protein (mAbs, Antibody-Drug Conjugates, Bispecific mAbs) and mAb Subunits Analysis
- Peptide Mapping and Protein Post-translational Modifications (PTM) Analysis
- Antibody Released N-Glycans Analysis
Key Learning Objectives:
- Better understanding of mAb-type of biotherapeutics
- Different analytical workflows for characterization of specific class of biotherapeutics
- Analytical tools on sample preparation, separation, detection, and data analysis
- Key critical quality attributes and testing methods
Who Should Attend:
- Biopharmaceutical analytical development scientists
Presenter: David Wong, PhD (Director, Global Biopharma Segment Marketing – Protein Therapeutics, Agilent Technologies, Inc.)
Dr. Wong has more than 20 years of experience working in the biotech/pharmaceutical industry. Over the past 8 years he was working as Sr. Applications Scientist and segment marketing manager at Agilent.During this time, he has been working on Biopharma applications development which resulted in 18 app note publications covering many key Biopharmaceutical areas.
Prior to joining Agilent, he worked as Research Scientist and the Proteomics (Mass Spectrometry) Group Leader at DuPont Industrial Bioscience Division (formally Genencor International, Inc.) located in Silicon Valley. Dr. Wong has strong expertise in both small and macromolecules characterization (Identification, Quantitation, Proteomics, Metabolomics and various BioPharma applications).
Dr. Wong received his Ph.D. in Biochemistry from University of California, Santa Barbara. He also served as a Post-doctoral Researcher at the UCSF Mass Spectrometry Facility, Dept. of Pharmaceutical Chemistry at University of California San Francisco.
