Journey of a Biotherapeutic -- from Characterization to Final Product


  • Overview
  • Venue
Date(s): 18 October 2017
Time: 9:00am - 4:15pm
Location: Rockville, MD
Language: English

The ongoing analytical requirements of producing today’s new peptide and protein therapeutics, including economical and ethical constraints, have laboratories continually pressed to attain increasing levels of performance and productivity. The development of sensitive methods for qualitative and quantitative analysis of these new biochemical modalities that are robust, reliable and reproducible are challenging. We will showcase the analysis of two monoclonals as they move from discovery and development into release testing - including characterization, comparability, and bioanalytical quantitation.

Agenda:

9:00am  Registration and Breakfast 
9:30am  Road Map for Establishing Biosimilarity: Characteriztion and Comparability of Biosimilar and Innovator Biotherateutics
Min Du, Ph.D., Biopharmaceutical Business Development Manager, Waters Corporation
10:15am  Break
10:30am  Is my Tire Flat or Round? Hydrogen Deuterium Exchange Mass Spectrometry for Probing Higher Order Structure of Protein Therapeutics
Asish Chakraborty, Ph.D., Business Development Manager, Waters Corporation
11:00am  How Much Fuel is in the Tank? Bioanalysis of a Biotherapeutic mAb in Late Discovery and Early Development
Kelly Doering, Ph.D., DMPK Business Development Manager, Waters Corporation 
12:00pm  Lunch
12:45pm  Which Travel App Should I Use? High Resolution Quantification: Comparing Surrogate Peptide and Intact Molecule Quantification of Biotherapeutics
Logan Umberger, Field Marketing Manager, Drug Metabolism/Bioanalysis, Waters Corporation
1:30pm  Going the Extra Mile--Blending Small and Large Molecules into Potent Drugs: Improved Analytical Workflows for Characterization of Antibody Drug Conjugates
Asish Chakraborty, Ph.D., Business Development Manager, Waters Corporation
2:15pm  Break
3:00pm  Efficient GPS Directions --Deploying a Fit for Purpose LCMS Platform for Regulated BioPharmaceutical Development and Quality Control
Min Du, Ph.D., Biopharmaceutical Business Development Manager, Waters Corporation
3:45pm What’s in Waters Tool Box?
Visit with members of the local team to discuss how Waters innovative tools for sample preparation, separations, mass spectrometry and informatics integrate to provide a powerful solution for this demanding environment.
4:15pm Wrap up and Departure

For additional information or questions, please contact Ann_Gray@waters.com.