Light Obscuration Measurements of Highly Viscous Solutions: Sample Pressurization Overcomes Underestimation of Subvisible Particle Counts
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 5
Abstract
Light obscuration (LO) is the current standard technique for subvisible particle analysis in the quality control of parenterally administered drugs, including therapeutic proteins. Some of those, however, exhibit high viscosities due to high protein concentrations, which can lead to false results by LO measurements. In this study, we show that elevated sample viscosities, from about 9 cP, lead to an underestimation of subvisible particle concentrations, which is easily overlooked when considering reported data alone. We evaluated a solution to this problem, which is the application of sample pressurization during analysis. The results show that this is an elegant way to restore the reliability of LO analysis of highly viscous products without the necessity of additional sample preparation.
Authors and Affiliations
Daniel Weinbuch, Wim Jiskoot, Andrea Hawe
Solid Lipid Particles for Oral Delivery of Peptide and Protein Drugs III — the Effect of Fed State Conditions on the In Vitro Release and Degradation of Desmopressin
The effect of food intake on the release and degradation of peptide drugs from solid lipid particles is unknown and was therefore investigated in vitro using different fed state media in a lipolysis model. Desmopressin w...
A White Paper—Consensus and Recommendations of a Global Harmonization Team on Assessing the Impact of Immunogenicity on Pharmacokinetic Measurements
The Global Bioanalysis Consortium (GBC) set up an international team to explore the impact of immunogenicity on pharmacokinetic (PK) assessments. The intent of this paper is to define the field and propose best practices...
Pharma Success in Product Development—Does Biotechnology Change the Paradigm in Product Development and Attrition
The biotechnology segment of the overall biopharma industry has existed for only about 40–45 years, as a driver of new product development. This driving force was initiated with the FDA approval of recomb...
Translating Human Effective Jejunal Intestinal Permeability to Surface-Dependent Intrinsic Permeability: a Pragmatic Method for a More Mechanistic Prediction of Regional Oral Drug Absorption
The online version of this article (doi:10.1208/s12248-015-9758-0) contains supplementary material, which is available to authorized users.
Synthesis and Pharmacological Evaluation of 6-Acetyl-3-(4-(4-(4-fluorophenyl)piperazin-1-yl)butyl)benzo[d]oxazol-2(3H)-one (SN79), a Cocaine Antagonist, in Rodents
The online version of this article (doi:10.1208/s12248-011-9274-9) contains supplementary material, which is available to authorized users.