Cookies

Like most websites The Analytical Scientist uses cookies. In order to deliver a personalized, responsive service and to improve the site, we remember and store information about how you use it. Learn more.
Fields & Applications Sample Preparation, Spectroscopy, Microscopy, Micro/Nano-scale, Technology, Data Analysis, Pharma & Biopharma, Materials

Characterization of protein aggregates in suspension and on a filter membrane by Morphologically-Directed Raman Spectroscopy

Using Morphologi G3-ID to Characterize Protein Aggregates in Stressed Lysozyme Sample

The combination of static microscopy and Raman spectroscopy in the Morphologi G3-ID enables automated chemical identification of protein aggregates and other contaminants in a biotherapeutic sample, either in suspension via a thin-path wet cell or on a filter membrane.

Introduction

Optical microscopy has long been used to characterize particulates present in biotherapeutic formulations, providing their size, shape, and transparency characteristics, which can then be used to group particulates into distinct classes (i.e. aggregates, silicone oil, sundry contaminants).  However, the ability of a microscope to provide explicit identification is limited to the two-dimensional images it collects.  The addition of Raman spectroscopy to an automated microscopy system provides a robust primary identification method for the verification of particle chemistry, and together the techniques offer the potential to enumerate, characterize, and identify particulates in native formulations, as well as those immobilized on a filter substrate.  This range of capabilities directly addresses FDA quality requirements for drugs administered by injection, in terms of particulate count per unit volume.  These regulations are put into practice through USP <788>¹, which calls for enumeration of particulates in two size categories: larger than 10 μm and larger than 25 μm.  The more recent release of USP <787>² (and <1787>) has extended recommendations to include sizes below 10 μm.  This lower size range has drawn considerable attention from the FDA due to concerns about immunogenic response related to proteinaceous aggregates³, reduced product efficacy, and general safety.  Formulation stability can be affected by many factors that lead to the formation of aggregated material4,5.

Read the full article now

Log in or register to read this article in full and gain access to The Analytical Scientist’s entire content archive. It’s FREE and always will be!

Login

Or register now - it’s free and always will be!

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Analytical Scientist magazine
Register

Or Login via Social Media

By clicking on any of the above social media links, you are agreeing to our Privacy Notice.

Register to The Analytical Scientist

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Analytical Scientist magazine

Register