Establish the properties of drug delivery complexes with certainty and precision

Characterise nanomedicines, drug-delivery complexes, and bionanoparticles with unsurpassed accuracy and precision. Obtain true measurements of the size distribution, particle concentration, particle charge and charge distribution. Carry out complex analyses of heterogenous samples including characterisation of individual subpopulations without the need for laborious protocols. Perform real-time measurements of particle properties to assess subtle changes over time with high precision for quality control and assessment of product stability.  

The field of nanomedicine is progressing rapidly, and specific regulatory procedures and requirements imposed by governing bodies are likely to come into play soon. As the only technique able to provide data of sufficient quality for such purposes, TRPS is fast becoming an essential aspect in nanomedicine characterisation and quality control.
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Present credible data, respected by the FDA

Completely credible, respected by the FDA
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Count individual particles reliably

Required for accurate dosage and response
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Measure the zeta-potential of each particle

Precision on a particle-by-particle basis.

Acquire number-based data

Obtain number-based size distribution data to ensure confidence in the reliability and accuracy of your results. Obtain reproducible data of actual particle diameter, rather than hydrodynamic radius (which varies with measurement conditions), as well as particle concentration in specified size bands to gain unique insight into the nature of the sample. Identify subpopulations or real-time accumulation of aggregates at a glance.

TRPS is well established in the field of nanomedicine as the most precise and accurate method of particle measurement. Single-particle measurements enable the generation of a number-based size distribution, which is not skewed by the presence of subpopulations of large particles and is an essential element of nanomedicine characterisation. As the only technique to provide such data, which will be required for regulatory pathways once specific regulations for nanomedicines come into play, TRPS is a critical aspect of nanomedicine product development. A true representation of the nature of the sample is obtained as subpopulations are revealed and can be individually analysed in terms of particle concentration. Automatic calibration and semi-automated operation mean that user error or inter-operator variation are minimised.
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Obtain credible data, suitable for regulatory purposes

Be prepared for the introduction of specific regulatory guidelines for nanomedicines by recording precise and accurate, number-based, single-particle data for your samples. Predict the in vitro and in vivo behaviour of complex drug products through comprehensive analysis of biophysical properties of your particles. Overcome current limitations and stay at the forefront of the field by utilising TRPS; the only standardised, single-particle method of characterising nanomedicines.

There are currently no specific regulatory guidelines for the use of nanomaterials in medicine, with nanomedicines being subject to the stringent legislation of general medicinal products. Specific guidelines are likely to come in to play very soon, and it is essential that laboratories are prepared for this. It is clear that the solution-averaged data provide by light- and laser-based (ensemble) techniques are inappropriate and will not be sufficient for regulatory purposes as these guidelines are established. Progress in the field has been limited by the lack of standardised, single-particle methods for characterising nanomedicines. TRPS is the only method to provide data suitable for current and future regulatory guidelines.

Record reliable, number-based measurements of particle concentration

Obtain accurate, number-based measurement of particle concentration to ensure appropriate dosing and drug loading of nanomedicines. Be confident in your quality control and validation processes and evaluations of in vivo particle interactions. Evaluate aggregation, bio interactions of nanoparticles, and the effects of filtering and freeze-thaw of samples.

Particle concentration, total and within specific size bands, needs to be precisely known at all stages of production, storage, and delivery of nanomedicines in order to assess the quality, yield, and extent of aggregation of the sample. As well as being a requirement of validation of complex drug products; the dosage, drug loading, and physicochemical equivalence can only be accurately evaluated when the precise concentration is known. As the only technique to offer number-based data of particle concentration within specified size ranges, which is accurate on a linear scale, TRPS is essential for analysis of heterogenous samples and a crucial aspect of nanomedicine development.
Particle zeta potential, size and concentration on a 3-axis graph.
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Measure the zeta-potential of each particle

Obtain detailed insight into the sample and predict particle behaviour through precise knowledge of surface charge. Measure zeta potential with single-particle resolution to gain unique insight into particle behaviour. Accurately determine key physicochemical properties such as particle number, size, and surface charge for the evaluation of bio interactions.

The in-vivo behaviour of nanoparticles is influenced by physicochemical properties of the particles; particularly, size and surface charge. Accurate measurement of surface charge or zeta potential is a critical aspect in nanomedicine development and regulation. TRPS is the only method to offer reliable, reproducible measurement of the zeta potential on a particle-by-particle basis. This data enables prediction of nanoparticle behaviour both in solution/during storage and in vivo and the single-particle resolution allows identification and individual analysis of subpopulations within complex samples. Because the technology does not rely on knowledge or input of the refractive index of particles, TRPS has the unique ability to determine the zeta potential of previously uncharacterised samples with ease.

Study particle interaction dynamically

Monitor and analyse reactions between nanoparticles with ease by carrying out real-time measurements of particle size, number, and zeta potential. Analyse antibody binding, aggregation, or ligand interactions at a glance by observing changes in surface charge. Evaluate affinity constants of binding, the presence of surface markers, and the stability of colloidal systems by obtaining data over time.

Binding of ligands or charged detector molecules such as DNA/RNA aptamers or antibodies with charged reporter molecules will alter the surface charge of nanoparticles or vesicles. This change occurs in a time-dependent manner depending on the affinity constant of the reaction. TRPS, therefore, enables evaluation of particle-ligand or particle-particle interactions and calculation of affinity constants by providing single-particle zeta potential data. Continual recording of data over time provides information of reaction kinetics, and reaction progress can be monitored at a glance through observation of the real-time data collection on the interface.
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