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Biophysical Characterization

Understanding the Higher-Order Structure stability of proteins for sustained potency and activity

Biophysical Characterization Services

Supporting Characterization, Comparability, and Preformulation Development


KBI Biopharma’s experts team acquire biophysical information on the simplest to the most complex drug molecules in your pipeline, while avoiding potential pitfalls, in order to make concise, well informed productive decisions about their development and manufacturing. Through our biophysical characterization services, our goal is to provide you with the analytical methods and formulation you need to maximize your protein higher-order structure stability to deliver prolonged activity and potency for safe biotherapeutics use.

The KBI Biopharma Rapid Analytics Biophysical Characterization Core functions as a contract research laboratory that specializes in biophysical analysis of protein conformation, stability, and aggregation. 

KBI routinely performs biophysical characterization to support characterization and comparability assessments in addition to preformulation development. 

Our biophysical characterization techniques have applications to small peptides, nucleic acids (like anti-sense therapeutics, aptamers, and ribozymes), small molecule drugs, carbohydrates, vaccines, viruses, drug-polymer conjugates, and more. Our expert team of scientists have experience with a wide variety of pharmaceutically-relevant macromolecular complexes, ranging from small peptides to large viral-derived complexes. 


Our Expertise Includes:

  • SV-AUC (Sedimentation Velocity Analytical Ultracentrifugation)
  • SE-AUC (Sedimentation Equilibrium Analytical Ultracentrifugation)
  • DSC (Differential Scanning Calorimetry)
  • DLS (Dynamic Light Scattering)
  • CD (Circular Dichroism)
  • FTIR (Fourier Transform Infrared Spectroscopy)
  • ICD (Isothermal Chemical Denaturation)
  • DSF (Differential Scanning Fluorimetry)
  • MALS (Multi-Angle Light Scattering)
  • Fluorescence Spectroscopy
  • High Resolution Mass Spectrometry

Characterization and Comparability
Methods and Services


The KBI Biopharma Rapid Analytics Biophysical Core specializes in biophysical and biochemical characterization of proteins, nucleic acids, and other macromolecule assemblies like viral vectors for gene therapy, protein-polymer conjugates, lipid nanoparticles, and more. We use various techniques to characterize or compare protein higher order structure (HOS). 

This includes methods to characterize:

  • Protein folding (secondary/tertiary structure)
  • Protein stability
  • Protein conformation
  • Protein aggregation
  • Oligomeric state - also called protein sub-units assembly - of the native protein (quaternary structure)

For characterizing oligomeric state and aggregation, we offer analytical ultracentrifugation (AUC), size-exclusion chromatography (SEC) with multi-angle light scattering (MALS) and dynamic light scattering (DLS) services. For characterization of protein conformation and stability, we primarily use circular dichroism (CD), Fourier transform infrared (FTIR), differential scanning calorimetry (DSC), and fluorescence. 

We can also quantify protein-protein or protein-ligand interactions for various applications, including functional assessment of antibody-antigen or hormone-receptor pairs using AUC and, when appropriate, DSC and fluorescence. 

Methods Summary

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Our goal is to help you get innovative biologics to patients, faster. 

The KBI Biopharma Analytics Portal offers a one-stop-shop for quote requests, ordering, sample submission and shipment tracking, and a single visualization of studies. This fast and easy self-service process streamlines analytics ordering and sample coordination. 

  • Customer-centric quote management
  • Sample submission and real-time tracking
  • Unified visualization of studies, reports, and results
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Explore Recent Resources


Adeno-Associated Virus-Mediated Gene Therapy: Analytical Advancements in Characterizing Size Distribution using SV-AUC and Multi-Wavelength Analysis for Accurate Identification of Resolved Species

At KBI Biopharma, we are leading the way in fully characterizing the size distribution of AAV products using SV-AUC combined with multi-wavelength analysis, giving us the ability to accurately identify each resolved species. 


Characterization and Quantification of Adeno-associated Virus Fill States Using Analytical Ultracentrifugation

In this poster, we show how this analysis can be used to identify empty, partially-packaged and full capsids, calculate the ratio of protein to DNA present in well resolved species, and compare the multi-wavelength results with expected values that arise from a consideration of the shape properties of AAVs. Furthermore, we show how this approach can help eliminate false peak identification. 


Comprehensive Size Distribution Analysis of Adeno-Associated Virus Fill States

In this poster, we compare the results from SV-AUC with MWA with two orthogonal separation methods: sedimentation equilibrium (SE) CsCl density gradient analysis and size exclusion chromatography coupled with multiple angle light scattering (SEC-MALS).

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