Analysis of Aggregates and Particles in Protein Pharmaceuticals

Featuring contributions from leading pharmaceutical investigators around the world, this text enables researchers to choose the most appropriate analytical methods in order to detect and characterize the full spectrum of protein aggregates and particles that can be present in a protein pharmaceutical. Moreover, the authors provide detailed examples of how these methods can be applied during both process and formulation development, helping researchers better manage the problem of protein instability as they seek to develop protein drugs.

The text begins with an introduction to aggregates and particles, focusing on their potential immunogenicity. Next, it covers:

• Methods to detect and measure soluble aggregates based on separation, light scattering, and new technology

• Methods to detect and measure insoluble aggregates and both sub-visible and visible particles

• Spectroscopic techniques such as UV/VIS, fluorescence, infrared and Raman spectroscopy, and microscopy to characterize aggregates and particles, elucidate their structures, and identify proteinaceous and non-proteinaceous particles

• Comparative advantages and disadvantages of the methods for protein aggregate analysis

• Approaches for managing aggregates and particles found during protein purification and formulation development

Throughout the text, case studies help researchers deal with the challenges that arise in detecting and analyzing protein aggregates and particles.

Protein pharmaceuticals are increasingly used to treat life-threatening and chronic diseases, including cancer, viral infections, metabolic disorders, and central nervous system diseases. With Analysis of Aggregates and Particles in Protein Pharmaceuticals as their guide, pharmaceutical researchers now have an important tool in overcoming the challenging problem of aggregates and particles in protein drug development.

WIM JISKOOT is Professor and Head of the Biologics Formulation Group in the Leidemsterdam Center for Drug Research (LACDR) at Leiden University.