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The CHROMacademy Essential Guide Webcast:
Native Mode Analysis of mAbs and ADCs- Intact Workflow Solutions for Characterizing Biomolecules by HIC and SEC Chromatography Techniques

North America: Tuesday 30th April 2019,
8:00am PDT/ 11:00am EDT

Europe: Wednesday 1st May 2019,
9:00am BST/ 10:00am CEST

Asia Pacific: Thursday 2nd May 2019,
8:30am IST/ 11:00am CST/ 12:00pm JST



 
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Key Learning Objectives

In this webcast, we will demonstrate the utility of SEC and HIC methods for intact analysis of antibodies and ADCs.
  • Case studies of a variety of antibodies and conjugates will be presented to illustrate the power of developing platform methods. These analytical starting points enable custom-tailored analytics for IPC (In-Process Checks) and release assays as projects enter CMC-endgames.
  • We will discuss how the analysis of the overall biophysical data of these biomolecules aids in the selection of the optimal candidates for further development towards the clinic.

Currently hundreds of therapeutic monoclonal Antibodies (mAbs) and Antibody Drug Conjugates (ADCs) are in development, and many companies have multiple biomolecules in their pipelines. Detailed analytical characterization of these biopharmaceutical proteins to assess the aggregation levels and other potential variations, such as protein deamidation and oxidation, are important to monitor to ensure product quality and safety.

Size exclusion chromatography is a standard 'bread and butter' analytical method used to quantify aggregation and purity of bio-proteins. Hydrophobic interaction chromatography, or HIC, is another powerful chromatographic technique for separating proteins in order of increasing hydrophobicity. It is also capable of resolving impurities and variants from post-translational modifications that can prove difficult by other orthogonal chromatographic methods.

Even for routine chromatographers that overly rely upon these methods could find benefit on further optimization. One such factor that depends upon column optimization is speed of analysis. Previously, 300-mm- length SEC columns of varying IDs were used to achieve better separation of HMWS (high-molecular weight species). In recent years, advances in column technology allow separation efficiencies on shorter length columns to be achieved. We will show examples of these advances via SEC and HIC analysis. Doubling sample throughput is invaluable to any drug discovery group or process project. Moreover, once throughput is increased, the scientist is enabled to execute more experiments in their DOE study matrixes.

Presented by
Edward Ha (Principal Scientist, Angiex)
Sandeep Kondaveeti (Application Scientist, Agilent Technologies)

Presenter Information »

 
 
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Edward Ha (Principal Scientist, Angiex)


Ed Ha was raised in New York City. Undergraduate studies, at Washington University and undertook graduate studies at UCLA in molecular recognition and artificial enzymes. Ed gained experience in antibody drug conjugates during his 10 years working at Genentech, where he contributed to the company’s pipeline of antibodies and ADCs. Currently, he continues to explore homogeneous conjugations and non-cytotoxin payload-linkers at Angiex in Cambridge, Massachusetts.

Sandeep Kondaveeti (Application Scientist, Agilent Technologies)


Sandeep is a Philadelphia native and currently works as an applications chemist responsible for developing Bio-pharma workflow applications with Agilent Technologies supporting bio-columns portfolio. Prior to joining Agilent, Sandeep undertook graduate studies at Temple University in Bioinorganic chemistry focused in developing Inorganic metal clusters based on Photosynthetic metalloenzymes and worked as Process Analytical Scientist for Janssen Pharmaceuticals through Eurofins.