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Related Concept Videos

Raman Spectroscopy Instrumentation: Overview01:26

Raman Spectroscopy Instrumentation: Overview

429
A conventional Raman spectrophotometer includes a laser source, a sample holding system, a wavelength selector, and a detector.
The monochromatic laser source, typically using visible or near-infrared radiation, generates a highly focused beam of light. This light interacts with the molecules of the sample, scattering some of the light. Liquid and gaseous samples are usually tested in ordinary glass capillaries, while solids can be analyzed as powders packed in capillaries or as potassium...
429
Raman Spectroscopy: Overview01:20

Raman Spectroscopy: Overview

415
The underlying principle of Raman spectroscopy is based on the interaction between light and matter, specifically molecules' inelastic scattering of photons. When a monochromatic beam of light, typically from a laser source, interacts with a sample, most scattered light has the same frequency as the incident light. This is known as Rayleigh scattering.
However, a small fraction of the scattered light exhibits a frequency shift due to the exchange of energy between the incident photons and...
415

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Morphologically-Directed Raman Spectroscopy as an Analytical Method for Subvisible Particle Characterization in

Minkyung Kim1, Youlong Ma2, Charudharshini Srinivasan2

  • 1Division of Biotechnology Research and Review II, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

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|November 22, 2023
PubMed
Summary
This summary is machine-generated.

Morphologically-Directed Raman Spectroscopy (MDRS) offers advanced subvisible particle (SVP) characterization for therapeutic proteins (TPs). This technique provides chemical identification and morphology data, complementing existing quality control methods.

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Area of Science:

  • Analytical Chemistry
  • Biopharmaceutical Science
  • Materials Science

Background:

  • Subvisible particles (SVPs) are critical quality attributes in injectable therapeutic proteins (TPs).
  • Current methods for SVP analysis provide size and count but lack chemical identification.
  • Root-cause analysis of SVPs requires detailed chemical and morphological characterization.

Purpose of the Study:

  • To introduce and validate Morphologically-Directed Raman Spectroscopy (MDRS) for SVP characterization in TPs.
  • To demonstrate MDRS's capability for chemical identification of individual SVPs.
  • To assess MDRS as a complementary tool in TP quality control workflows.

Main Methods:

  • Method development using polystyrene microspheres, SU-8, and ethylene tetrafluoroethylene (ETFE) particles.
  • Application of MDRS for high-resolution imaging and Raman spectroscopy of SVPs.
  • Comparison of MDRS morphology data with flow imaging microscopy.
  • Characterization of particles in stressed TPs.

Main Results:

  • MDRS provided high-resolution images of ETFE particles (19-100 μm), comparable to flow imaging microscopy.
  • The method enabled chemical identification of individual SVPs in stressed TPs using Raman spectroscopy.
  • MDRS successfully compared morphology and transparency of proteinaceous particles with reference materials.

Conclusions:

  • MDRS is a powerful technique for detailed SVP characterization of TPs.
  • It offers chemical identification and morphological insights, complementing existing analytical methods.
  • MDRS can enhance product quality characterization throughout the TP development and commercial lifecycle.