Analytical Approaches for Assessing Aggregation of Protein Biopharmaceuticals

Title: Analytical Approaches for Assessing Aggregation of Protein Biopharmaceuticals

Volume: 12 Issue: 10

Author(s): Elena Garcia-Fruitos, Esther Vazquez, Nuria Gonzalez-Montalban, Neus Ferrer-Miralles and Antonio Villaverde

Affiliation:

Keywords: Analytical procedures, aggregation, protein drugs, recombinant proteins, screening, protein-based pharmaceuticals, nanomedicine, protein folding and misfolding, microbial cells, conformational quality and, aggregation of recombinant drugs, apparent solubility

Abstract: Production of protein-based pharmaceuticals is a major issue in conventional pharmacology, biomedicine and nanomedicine. Being mostly obtained by genetic engineering, the quality and activity of protein drugs is a steady matter of concern. Although the physiology of the host recombinant cells, mostly mammalian and microbial, is progressively understood, the complexity of the cellular quality control systems escapes rational protein and process engineering, and recombinant proteins are often unstable, aggregate and/or do not reach the fully native conformation compatible with proper biological activity. In this review, we summarize the main biological aspects of protein folding and misfolding, mainly focusing in microbial cells, the newest insights in the biological control of protein quality and the main and analytical approaches that are suitable for the fast evaluation of the conformational quality and aggregation of recombinant drugs, even if showing apparent solubility.

Cite this article as:

Garcia-Fruitos Elena, Vazquez Esther, Gonzalez-Montalban Nuria, Ferrer-Miralles Neus and Villaverde Antonio, Analytical Approaches for Assessing Aggregation of Protein Biopharmaceuticals, Current Pharmaceutical Biotechnology 2011; 12 (10) . https://dx.doi.org/10.2174/138920111798357339