ResourceLife Sciences
Differentiation and Characterization of Subvisible Particulates in Therapeutic Protein Products
15 Jul 2014Guidance from the FDA for the biopharmaceutical industry states “Naturally sourced products should be evaluated for other components, protein and non-protein”. This application note provides an example of how the Malvern Instruments’ Archimedes system can be used to detect and quantify the formation of protein sub-visible particles and the introduction of silicone oil droplets, in response to shear stress.
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ProteomicsProteomics is the systemic bioinformatics study of proteins and amino acids, including their structure, size, function and identification. Tools used in proteomics include chromatography, blotting and gels, protein arrays, mass spectrometry and ELISA and associated analysis software. Analyzers and proteomic systems should be sensitive, high resolution, fast and may be automated for high-throughput.Particle CharacterizationParticle characterization instruments are used to determine particle size distribution, shape, surface area, zeta potential, density and porosity of particles and materials. Multiple tecchniques are available for determining particle size, shape and count including dynamic light scattering (DLS), laser diffraction, electrozone (Coulter technique), imaging particle analysis and single particle optical sensing. Determine the density of your material with a gas pycnometer or examine its surface area and porosity with gas adsorption analyzers and mercury porosimeters. Find the best particle characterization instruments in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. TherapeuticsTherapeutics are treatments designed to alleviate or cure diseases. These include pharmaceuticals, biologics, and gene therapies, which work by targeting specific disease mechanisms. Advances in personalized medicine and biologics offer new hope for patients with conditions that were previously difficult to treat. Browse our peer-reviewed product directory to find therapeutic solutions for various diseases; compare products, check user reviews, and get pricing directly from manufacturers.