Advancing Structural Characterization of Therapeutic Proteins with Microfluidic Modulation Spectroscopy

Existing tools for measuring and monitoring the structure of biotherapeutic molecules during formulation have had until now very significant limitations in sensitivity and have been very difficult to use. In this webinar, Amgen shares data that demonstrates the power of Microfluidic Modulation Spectroscopy (MMS), a valuable, fully-automated IR technology, to generate high-quality, reproducible secondary structure data for protein therapeutics, including monoclonal antibodies.

  • Free

Why attend?

Infrared (IR) spectroscopy first came into use for characterizing proteins and peptides in the 1950’s and has since gained acceptance as a powerful tool for protein and peptide characterization.

By monitoring higher-order structure, IR spectroscopy is often applied as part of the assessment of critical quality attributes of therapeutic proteins throughout the development process. Other common structural characterization methods such as FTIR and CD have known drawbacks in reproducibility, sensitivity, and interference from buffers, which adversely increase the lowest level of quantitation (LOQ) achievable when measuring structural impurities and similarity. These limitations directly affect data quality, giving way to the risk of downstream product failure – a top concern to the biopharma formulator due to the impact on project timeline and budget.

In this webinar you will discover how data quality can be significantly improved through the use of Microfluidic Modulation Spectroscopy (MMS); a novel automated IR technology that has proven to be an effective technique for generating high-quality, reproducible secondary structure data for protein therapeutics including monoclonal antibodies, even at low concentrations. Data will be shared to illustrate how researchers at Amgen Inc. of Thousand Oaks, CA analyzed monoclonal antibodies (mAbs) at concentrations ranging from 0.5 to 50 mg/mL and obtained superior data by optimizing detector dwell time settings.

Additionally, we will discuss how the ability to generate reproducible data with high sensitivity at low formulation concentrations supports the use of MMS as a more reliable, cost-effective, and comprehensive method for evaluating secondary structure of low concentration biotherapeutic formulations and modalities vs traditional IR techniques.


Amgen demonstrated how they can increase productivity and de-risk product failure in their biotherapeutic formulation process by more confidently detecting changes in protein structure using MMS.

Register for this event TODAY and take your first step toward developing better formulations, faster and with greater confidence.

Key Learning Objectives

  • How Amgen obtained high-quality structural data on low concentration mAbs to enable more confident decision-making in the formulation process
  • How to detect previously undetectable structural changes in therapeutic proteins to profoundly affect quality control outcomes using MMS
  • The fundamentals of Microfluidic Modulation Spectroscopy ​​​​and advantages over existing techniques

Target Audience

  • Director
  • Biomedicine Design, Discovery Bioanalytical and Critical Reagents Group
  • Analytical Services
  • Research & Development
  • Formulation Scientist
  • HTPD Development Lead 
  • Principal Scientist
  • Assistant Principal Scientist
  • Formulation
  • Bioanalytical
  • Biophysical
  • Discovery

Speakers

Select a speaker to learn more

Valerie Ivancic, PhD
Senior Application Scientist, RedShiftBio

Valerie Ivancic, Ph.D. is a Senior Application Scientist at RedShiftBio. She was involved in one of the first Beta tests for the AQS³pro while in graduate school at Clark University in Worcester, MA. In graduate school, Valerie worked in a Biophysical Chemistry lab gaining experience in protein expression and purification, CD, NMR, fluorescence spectroscopy, mass spectrometry, transmission electron microscopy, and computer simulations in order to address new ways of detecting, inhibiting, and degrading amyloid assemblies.

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Dipanwita (Dipa) Batabyal, PhD
Senior Scientist, Process Development at Amgen

Dipanwita (Dipa) Batabyal, PhD is a Senior Scientist at Amgen Inc, Process Development in Biological Relevance and Characterization (Attribute Sciences). She is the SME in the higher order structure (HOS) group for various spectroscopic techniques like FTIR, MMS, CD, intrinsic fluorescence and extinction coefficient for product characterization and technology development initiatives. Dipa received her PhD from Albert Einstein College of Medicine, NY in biophysics and molecular biology where her research focused on structural and functional characterization of heme dioxygenases using enzymology and resonance Raman spectroscopy. Prior to joining Amgen, she was a project scientist/postdoctoral fellow at UC Irvine where her research focused on structural and functional characterization of cytochrome P450s using crystallography, enzymology, and spectroscopy.

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