Malvern Instruments particle characterization products apply advanced technologies such as photon correlation spectroscopy

More information:
	Industry overview
	Industry concerns
	Malvern analyzer for biotechnology
Case studies:
	Monoclonal Antibody Characterization
	Measurement of Lipoproteins Using Photon Correlation Spectroscopy
	Measurement of Lipoproteins Using the Zetasizer
	Boehringer Ingelheim chooses Zetasizer HS for Particle Size Measurement in Biological Materials

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Yield

Improving product process yield

Process yield improvements are the result of optimizing existing facilities to achieve more favourable product specifications within existing economic constraints. It is often accepted that existing processes are not optimized. The processes may be adequate and may consistently provide acceptable quality product, but new conditions could warrant review and modification of the method to improve product quality and quantity.

Any process predominantly depends on product stability during the course of the method. A good parameter to monitor and improve on this stability is the zeta potential. Detailed knowledge of particle zeta potential and particle size may aid, for example, in ultra-filtration and purification processes. In simple terms, attempting to send a particle through a micro-filtration process when the particle size is larger than the pore size will be met with doubtful success. A preparation with smaller particle size (or larger filter pore size) has a higher chance of yielding product. Often, the product’s size and adhesion properties are affected by the solution conditions of the mobile phase. Here, non-invasive techniques are the preferred choice to characterize the system in solution.

The particle size and electrophoretic mobility of the suspension can be measured in a Zetasizer instrument. This provides information on the state of the dispersion and can be used to formulate the production process to prevent flocculation and improve long term stability.


	Presentations:

	On demand presentation on:"What Affects Dispersion Stability and How Can We Predict It?". The stability of a particle dispersion is determined by the balance between repulsive and attractive forces which the particles experience as they approach one another. This presentation discusses how dispersion stability can be achieved, what factors influence it and how an understanding of these factors can be used to predict the shelf life of a product.


	Application notes:

	Process Prediction in Protein Processing. Details how a knowledge of protein size and protein zeta potential can result in the successful prediction of process operation, with examples from the ultrafiltration and ion exchange of proteins.


	The Relevance of Particle Size in Protein Processing. Shows how photon correlation spectroscopy (PCS) can be used to choose the optimum conditions for the microfiltration of protein solutions.


	The Relevance of Zeta Potential in Protein Processing. Details how measurement of electrophoretic mobility (and hence determination of zeta potential) can be used to test descriptions of the surface properties of proteins and hence validate predictions of their properties over a wide range of solution conditions.


	Size and Zeta Potential Characterization Liposomes on the Zetasizer Nano. The physical characterization of liposomes is of great importance in understanding their suitability for a range of applications. Knowledge of the zeta potential of a liposome preparation can help to predict the fate of the liposomes in vivo.


	Pharmaceutical Drug Development Screening for Promiscuous Inhibitors. New lead compounds for drug design are typically discovered using high throughput combinatorial techniques that utilize large screening databases of known compounds. These small molecule databases however, have been shown to contain promiscuous inhibitors that function as effective enzyme inhibitors, while exhibiting non drug-like traits such as poor specificity and uncorrelated structure-function relationships. Recent studies indicate that the concentration dependent inhibitory nature of these promiscuous inhibitors is a direct consequence of non-specific aggregation, i.e. when the molecule is aggregated it functions as an effective inhibitor; when aggregation is absent, so is the inhibitory activity of the compound. While the mechanism for this aggregation controlled inhibition is still under examination, the suggested pathway is one wherein the enzyme absorbs either onto the surface or into the interior of the drug aggregate, which subsequently restricts active site access. Photon correlation spectroscopy or dynamic light scattering (DLS) is an analytical technique capable of measuring the size of very small particles, at low sample concentrations. Because of the molecular weight dependence of the particle scattering intensity, the technique is extremely sensitive to the presence of aggregates. As such, DLS is an ideally suited screening tool for identifying promiscuous inhibitors from the cache of lead compound candidates selected from small molecular databases. This application note summarizes measurements performed on a candidate drug that exhibits inhibitory behavior at certain concentrations..