title: Proteins behaving badly: emerging technologies in profiling biopharmaceutical aggregation.
abstract: Over recent decades biotechnology has made significant advances owing to the emergence of powerful biochemical and biophysical instrumentation. The development of such technologies has enabled high-throughput assessment of compounds, the implementation of recombinant DNA technology, and large-scale manufacture of monoclonal antibodies. Such innovations have ultimately resulted in the current experienced biopharmaceutical stronghold in the therapeutic market. Yet aggregate prediction and profiling remains a challenge in the formulation of biopharmaceuticals due to artifacts associated with each analytical method. We review some emerging trends and novel technologies that offer a promising potential for accurately predicting and profiling protein aggregation at various stages of biopharmaceutical product design.
authors.affiliation: School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester, UK.
authors.forename: Zahra
authors.initials: Z
authors.lastname: Hamrang
authors.forename: Nicholas J W
authors.initials: NJ
authors.lastname: Rattray
authors.forename: Alain
authors.initials: A
authors.lastname: Pluen
mesh_terms: D001688:Biological Products / Q000737:chemistry*; D001709:Biotechnology / Q000379:methods; D002623:Chemistry Techniques, Analytical / Q000379:methods; D011489:Protein Denaturation; D011506:Proteins / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D001688:Biological Products; D011506:Proteins
keywords: aggregation; biopharmaceuticals; manufacture; product development; quality by design