The characterization of particulate matter, especially protein aggregates, in the sub-visible and visible size range has become an area of focus in the biopharmaceutical industry. This heightened focus is due, in part, to increasing concern around particles causing immunogenicity, and increased queries from regulatory bodies. There has been extensive research in this area, with many recent publications on related methodologies, mechanisms and influencing factors. Two areas of interest are the characterization of these particles using material sparing approaches and the effect of the presence of silicone oil particles on protein solutions. With the focus on high concentration drug products (¡Ý50 mg/mL), and the drive toward conserving drug p...
Silicone oil, a lubricant in pharmaceutical containers, has been implicated as a risk factor for pro...
The ability to characterize micrometer and submicrometer particles in solution is of fundamental imp...
This thesis is a compilation of multiple techniques developed to characterise solutions of proteins,...
The characterization of particulate matter, especially protein aggregates, in the sub-visible and vi...
Particles are omnipresent in biopharmaceutical products. In protein-based therapeutics such particle...
The aim of this thesis was to identify and evaluate critical factors for protein particle analysis a...
Particles in biopharmaceutical formulations remain a hot topic in drug product development. With new...
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Mas...
Therapeutic proteins have become very successful in the treatment of various chronic and life-thre...
Control and analysis of protein aggregation is an increasing challenge to biopharmaceutical research...
The goal of the research presented in this dissertation is to develop analytical techniques for the ...
Characterisation of particulates in therapeutic monoclonal antibody (mAb) formulations is routinely ...
The US and EU pharmacopeias require sub-visible particle (SbVP) testing of parenteral drug products ...
Characterization of biopharmaceuticals is necessary for ensuring their purity and structural integri...
This thesis describes a number of novel experiments contributing to the understanding of protein ads...
Silicone oil, a lubricant in pharmaceutical containers, has been implicated as a risk factor for pro...
The ability to characterize micrometer and submicrometer particles in solution is of fundamental imp...
This thesis is a compilation of multiple techniques developed to characterise solutions of proteins,...
The characterization of particulate matter, especially protein aggregates, in the sub-visible and vi...
Particles are omnipresent in biopharmaceutical products. In protein-based therapeutics such particle...
The aim of this thesis was to identify and evaluate critical factors for protein particle analysis a...
Particles in biopharmaceutical formulations remain a hot topic in drug product development. With new...
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Mas...
Therapeutic proteins have become very successful in the treatment of various chronic and life-thre...
Control and analysis of protein aggregation is an increasing challenge to biopharmaceutical research...
The goal of the research presented in this dissertation is to develop analytical techniques for the ...
Characterisation of particulates in therapeutic monoclonal antibody (mAb) formulations is routinely ...
The US and EU pharmacopeias require sub-visible particle (SbVP) testing of parenteral drug products ...
Characterization of biopharmaceuticals is necessary for ensuring their purity and structural integri...
This thesis describes a number of novel experiments contributing to the understanding of protein ads...
Silicone oil, a lubricant in pharmaceutical containers, has been implicated as a risk factor for pro...
The ability to characterize micrometer and submicrometer particles in solution is of fundamental imp...
This thesis is a compilation of multiple techniques developed to characterise solutions of proteins,...