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Monitoring heterogeneity in therapeutic samples using Schlieren.

Rishabh V More1, Andres Barrio-Zhang1, Adib Ahmadzadegan1

  • 1School of Mechanical Engineering, Purdue University, West Lafayette, IN 47907, USA.

International Journal of Pharmaceutics
|September 25, 2021
PubMed
Summary

A portable Schlieren setup detects and quantifies heterogeneities in therapeutic biomolecule solutions during thawing. This method ensures sample quality and optimizes pharmaceutical development and storage.

Keywords:
AntibodyAntigenBiologicsFreeze-thawHeterogeneitiesMixing controlSchlieren

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Area of Science:

  • Biophysical Chemistry
  • Pharmaceutical Science
  • Analytical Chemistry

Background:

  • Therapeutic biomolecule solutions face physical and chemical changes during development, manufacturing, transport, and storage.
  • These changes, such as freeze-thawing, can cause aggregation and heterogeneities, reducing sample quality.
  • Monitoring sample homogeneity is critical for consistent quality and process optimization.

Purpose of the Study:

  • To present a simple, portable all-lens Schlieren setup for real-time detection, visualization, and quantification of heterogeneities in pharmaceutical solutions.
  • To demonstrate the setup's capability in monitoring thawing processes of protein solutions.
  • To establish a method for quantifying concentration gradients from light intensity variations.

Main Methods:

  • Utilized a portable all-lens Schlieren setup to capture light intensity variations caused by concentration gradients in thawing samples.
  • Measured the refractive index of sample solutions to establish a linear relationship with concentration.
  • Extracted concentration gradient fields from light intensity data using the refractive index-concentration relationship.
  • Validated the approach by measuring the diffusion coefficient of a diffusing interface.

Main Results:

  • Successfully visualized and quantified heterogeneities during the thawing of Bovine Serum Albumin (BSA) and Immunoglobulin G (IgG) in various buffers.
  • Demonstrated the quantitative accuracy of the Schlieren technique in relating light intensity variations to concentration gradients.
  • Established the method's validity through accurate measurement of a diffusion coefficient.

Conclusions:

  • The portable Schlieren setup is effective for real-time monitoring of mixing and heterogeneity in pharmaceutical solutions.
  • This technique is applicable to a wide range of therapeutic biomolecules, aiding in stability assessment.
  • The method offers a valuable tool for ensuring the quality and consistency of pharmaceutical samples throughout their lifecycle.