Measurement of particle concentration is a ubiquitous requirement across a diverse range of applications. In many cases knowing just particle size is not enough, as sample concentration may also affect the performance of the product or the biological response to a drug delivery vector for example. In addition, there is increasing requirement to measure particle concentration which is being driven by the EU definition of a Nanomaterial. This definition stipulates that a sample containing 50% or more of its particles by a number distribution, with a size smaller than 100nm, may need to identified as a nanomaterial and thus regulated as such.
There are a wide variety of applications in which the measurement of particle concentration is critically important, including:
- Biopharmaceutical (including vaccine) development, manufacture and quality assurance, in which the titer of virus is related to the viral dosage and resultant performance of the vaccine.
- Protein aggregation studies, including accelerated stress testing and stability studies.
- Differentiation and concentration measurement of sub-visible protein aggregates and silicone oil droplets in pre-filled syringe aggregation studies.
- Drug delivery in which the biological response to the drug may be influenced by the concentration and particle size of the delivery vector.
- Exosomes and microvesicle research in which the concentration of specific exosomes and microvesicles may be indicative of the onset of disease and therefore is of interest in the area of disease diagnostics. Nanoparticle toxicology in which the concentration of particles within a biological or ecological environment may influence the biological response to the nanoparticles from a toxicity perspective. Regulatory requirements as a result of the EU definition of a nanomaterial in which number based distributions determine whether a material is classed as a nanomaterial or not.
Malvern Instruments supplies two unique technologies for measuring particle concentration namely; Nanoparticle Tracking Analysis (NTA) and Resonant Mass Measurement (RMM). These two technologies provide concentration measurement across a wide dynamic range of concentrations and sizes, with a range of complimentary measurands also available such as particle size, single particle zeta potential, particle mass measurement and particle fluorescence.