Journal of Analytical & Bioanalytical Techniques
Open Access

Abstract

A good characterisation of the protein aggregation states and of the presence of particulate matter in biopharmaceuticals can only be achieved through a convergence of evidence from numerous classical and orthogonal analytical methods. Based on case studies, different new orthogonal methods will be presented. No single method can be used as an absolute characterisation of the aggregation states. Only by using together many different, complementary methods we can obtain reliable conclusions and reveal an abroad picture on the protein aggregation states and the presence of particulate matter in biopharmaceuticals.

Biography

Tudor Arvinte, PhD received his academic training in physics at the University of Jassy, Romania, and his PhD in biophysics from the University of Düsseldorf, Germany. He performed his Doctoral work and Postdoctoral stage at the Max-Planck-Institute West Germany and held numerous research positions in Europe and the USA: at C.N.R.S., Orléans, France, at Cornell University, New York, at Texas A&M University, and at the Biophor Corporation, College Station, Texas, USA. In 1989 he joined Ciba-Geigy Pharmaceuticals in Horsham, England, and in 1994 he moved to Ciba- Geigy in Basel, Switzerland. Until 2002 he worked as Head of Exploratory Formulation, Novartis Biotechnology Development & Production, Basel. He worked on the characterization and formulation of more than 130 protein and peptide drugs. He has over 80 publications and holds 13 patents on formulations of proteins: one patented formulation for hirudin is used in the marketed product. Since 2001 he is invited Professor at the School of Pharmacy, University of Geneva, Switzerland, where he is teaching a post-graduate course on “Formulation and delivery of protein biopharmaceuticals”. He is also Visiting Professor at the Department of Pharmacy, School of Health and Life Sciences King’s College London, UK. In 2003 he co-founded Therapeomic, Inc., a biotech company focused on developing formulations for biopharmaceuticals in collaborations with pharmaceutical companies.

Email: tudor.arvinte@unige.ch