Malvern Panalytical has launched a new system based around Taylor Dispersion Analysis (TDA) to provide researchers with a novel orthogonal technique to accelerate biopharmaceutical drug candidates through the development pipeline.
The Viscosizer TD speeds up stability and formulation studies by offering unique solution-based molecular sizing capabilities, combined with relative viscosity measurement. Ultra-low sample volumes, fully automated measurement protocols, and precise environmental control for sample storage and measurement further enhance the value of the new system for early developability screening. To find out more visit www.malvern.com/viscosizer.
The Viscosizer TD, a new automated biophysical characterization tool
TDA is a microcapillary flow-based technique that enables the sizing of small molecules, peptides and proteins, and samples containing mixtures of these species. Measurements of hydrodynamic size in different solution conditions are a critical element of screening and formulation studies because they give insight into the conformational stability and self-association behavior of a candidate drug.
However, such measurements can be challenging because of the limited availability of target proteins at the candidate validation stage. Into early stage formulation development, candidate molecules are further worked up into complex buffer and excipient backgrounds, and can be present at a concentration – either high or low - that complicates analysis.
The Viscosizer TD uses TDA with UV-absorbance detection to directly address these issues and deliver hydrodynamic sizing in the range 0.2 to 50 nm radius. Target molecule detection is selective on the basis of the UV wavelength used in the measurement. In addition, the ability to baseline the system against a matched sample buffer offers novel measurement capabilities for label-free analysis of biomolecules in complex formulations.
TDA can be used to monitor stability and self-association of target molecules in mixtures of excipients and surfactants for example, without measurement interference. Furthermore, measurements are not adversely affected by the presence of low levels of aggregates so samples can be run without dilution of filtration. The capability to work in biologically-relevant solutions makes TDA highly complementary to established tools such as Dynamic Light Scattering (DLS) and Size Exclusion Chromatography (SEC).
The Viscosizer TD also allows relative viscosity measurements, via a microcapillary flow-based methodology, using Poiseuille’s law. A unique dual pass timing approach enables high resolution viscosity measurements with high reproducibility, particularly in the low concentration and low viscosity regime.
These measurements are highly complementary to TDA sizing, and used in combination as an early developability screen for candidates, provide crucial data for stability and formulation using a minimal amount of sample.
Triplicate measurements of both size and relative viscosity are accessible with a total sample volume of around 35 microliters. Allied with automated measurement protocols, the new Viscosizer TD system is well-suited to a multiple sample screening environment.
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About Malvern Panalytical
Malvern Panalytical provides the materials and biophysical characterization technology and expertise that enables scientists and engineers to understand and control the properties of dispersed systems. These systems range from proteins and polymers in solution, particle and nanoparticle suspensions and emulsions, through to sprays and aerosols, industrial bulk powders and high concentration slurries. Used at all stages of research, development and manufacturing, Malvern Panalytical’s materials characterization instruments provide critical information that helps accelerate research and product development, enhance and maintain product quality and optimize process efficiency.
Our products reflect Malvern Panalytical’s drive to exploit the latest technological innovations and our commitment to maximizing the potential of established techniques. They are used by both industry and academia, in sectors ranging from pharmaceuticals and biopharmaceuticals to bulk chemicals, cement, plastics and polymers, energy and the environment.
Malvern Panalytical systems are used to measure particle size, particle shape, zeta potential, protein charge, molecular weight, mass, size and conformation, nanoparticle size and count, rheological properties and for chemical identification, advancing the understanding of dispersed systems across many different industries and applications.
Headquartered in Malvern Panalytical, UK, Malvern Panalytical has subsidiary organizations in all major European markets, North America, Mexico, China, Japan and Korea, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com