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Characterization of nucleic acid-based vaccines delivered as viral and non-viral vectors requires fit-for-purpose analytics and a significant level of method understanding In this peer-reviewed paper, you’ll discover how first-principle, label-free biophysical techniques can be applied to the characterization of the critical quality attributes of viruses and lipid nanoparticles. You’ll learn: How the combination of complementary label-free biophysical techniques have been successfully used for the characterization of physical and chemical attributes of rAAV and LNPs encapsulating mRNAExplore analytical techniques, including dynamic light scattering (DLS), multiangle-DLS (MADLS), Electrophoretic Light Scattering (ELS), nanoparticle tracking analysis (NTA), multiple detection SEC and differential scanning calorimetry (DSC)How to apply these techniques to measure multiple, critical quality attributes, including particle size distribution, aggregation propensity, polydispersity, particle concentration, particle structural properties and nucleic acid payload

Drugs based on proteins, or biopharmaceuticals are useful for the treatment of a wide range of illnesses and form one of the fastest-growing areas in medical research. As these products are used in vivo to treat disease, they are subject to extremely high regulatory burdens and must be able to demonstrate that they are effective but also safe. The stability and aggregate level that these biologics contain is of primary concern as they influence the efficacy and immunogenicity of the final product. Detailed information on these parameters needs to be provided to help scientists drive development in the direction that produces a high quality and reliable product. Importantly it is also essential information for regulators to qualify and allow the release of the product. Changes in FDA regulations allowed the development of biosimilars which have the same function as the innovator but are significantly cheaper. Biosimilars have shortened licensing pathways when compared to innovator materials if they can be shown to be biologically similar to already licensed products. For a product to be considered as biosimilar it must undergo detailed analytical studies demonstrating that it is highly similar to the innovator and include information to show that it is expected to produce the same clinical response as the innovator in any given patient. A successful biosimilar program has comparative analytical data as its foundation. As part of the analytical study, the FDA requires the use of state-of-the-art technology to compare higher-order structures, including aggregation, of the biosimilars with the innovator in addition to any formulation effects on purity, stability, product and process-related impurities. Log in or register for free to read more.

The quality of metal parts produced by powder-bed additive manufacture is intrinsically bound to the quality of the feedstock material – metal powders. Particle size distribution is a key metric that is used to certify and monitor the quality of metal powders both prior to first use and during powder recycling. Two techniques are typically deployed for this – laser diffraction for the smaller particle size fractions and sieve analysis for the larger particles. While sieve analysis remains a popular and established sizing technique for larger particles, the addition of a dynamic imaging accessory to your laser diffraction system can allow you to measure the complete size distribution in a single test.

The Zetasizer Advance series has the capability of measuring the size, particle concentration and zeta potential of colloidal dispersions using dynamic (DLS) and electrophoretic light scattering (ELS) [1-3]. These techniques are used extensively in lipid nanoparticle and liposome research for characterization purposes [4,5]. The number of peer reviewed papers highlighting the use of the Zetasizer Advance and Nano in these research areas exceed 50,000, confirming the versatility and usability of light scattering techniques. Download this application note to learn how Dynamic Light Scattering (DLS) and Electrophoretic Light Scattering (ELS) can be used in the characterization of liposomes and lipid nanoparticles to understand their suitability for a range of different applications. You'll learn why size and zeta potential are key critical quality attributes (CQAs) in a range of formulations and how changes in these parameters can provide stability information.

In archaeological research, mineralogical analysis can deliver important insights into an artifact’s use, manufacture, and originality. However, researchers must ensure that the analysis method is not destructive to the artifact. X-ray diffraction is a useful way to carry out mineralogical analysis without damaging artifacts. This application note outlines the process and results of non-destructive testing with the Empyrean diffractometer (equipped with a microdiffraction technique) on the materials of two Erlitou Bronze Age plaques. Erlitou was a Chinese early Bronze Age urban society in Henan Province between 2000 and 1500 BC. Erlitou was the largest capital in the Chinese region until 1500 BC, with several palaces, and was a center of production for bronze objects. The Erlitou society is probably connected to the Xia dynasty, often considered the first dynasty in Chinese history. A small number (under 20) of plaques with turquoise pieces in the shape of an animal mask are known from Erlitou culture. Characteristic elements are symmetry, raised eyes, small eyelets, and the use of mostly rectangular inlay. The two plaques tested were of this kind, from a private collection, and measured 14.1 x 9.5 cm and 13.8 x 9 cm, respectively. Please login or register for free to read more.

This datasheet investigates the capabilities of the Zetium 4 kW, a wavelength dispersive X-ray fluorescence spectrometer, as a tool to do Trace-analysis of Mercury in Iron-ore.

The stability of colloids in a formulation is important for the quality of a product. Processes such as aggregation can lead to final products which are not optimum for use, such as paint, with visible lumps, or inks which do not re-suspend fully and therefore could potentially block inkjet nozzles. With more complex products, multiple materials are combined from various sources, and the conditions under which they are transported and stored in can vary. Consequently, when combining these component parts, the pH and ionic strength of the formulation can vary. To avoid catastrophic product failure, such as the scenarios mentioned above, it is important to gain an understanding of the components of the system and how they behave across varying pH and ionic strengths to ensure that they remain stable across any chemical changes they may be subjected to during production. This application note discusses the use of the multipurpose titrator MPT-3 in studying the effect of salt concentration on stable pH ranges. The MPT-3 is an accessory available for the Zetasizer Advance product range.

Additive Manufacturing (AM) is a term used to describe advanced production methods whereby materials are selectively connected layer by layer to produce a part based on a 3D model. It is ideal for rapid prototyping and can be used to produce much more complex parts when compared to traditional subtractive methods, while typically producing less waste. This study looks at polymer powders used in Powder Bed Fusion (PBF) processes such as Laser Sintering (LS), which is illustrated in Figure 1. Figure 1. Diagram showing a typical Powder Bed Fusion (PBF) process. With increasing interest in using these processes for end-use manufacture, there is a need to both expand the range of materials available, and to better understand the ways in which materials behave within the processes themselves. This Application Note looks at how particle size and shape distributions measured on the Morphologi 4 provide insight into the density and flow data obtained from standard powder tests for three different polymers used in PBF additive manufacturing. Please login or register for free to read more.

Stringent regulations of occupational exposure to respirable silica pose a significant challenge to analytical methods and instrumentation. This note gives an overview of the capabilities of Malvern Panalytical diffractometers to meet this challenge. Both the 600 W Aeris compact diffractometer and the full-power Empyrean diffractometers can deliver sensitivity in compliance with the existing norms and regulations. Aeris can be equipped with 6 position autosampler for unattended measurement on up to 6 samples in one batch. Empyrean on the other hand can be configured with up to 45 position autosampler for higher throughput requirements. The compact Aeris diffractometer offers cost-effective solution for routine filter screening; whilst the multi-purpose Empyrean diffractometer opens additional possibilities: filter screening with improved sensitivity, higher sample throughput, a wide variety of other X-ray scattering applications for R&D purposes. Please login or register for free to read more.

Step-growth polymerization involves the reaction of two complementary functional groups creating repetitive linkages to form long linear chains of repeat units. As this occurs randomly, there is competition between linear polymerization and cyclic oligomer byproducts which comprise dimer, trimer, or higher order structures [1]. These cyclic byproducts can either be beneficial or detrimental depending on the desired final material properties. Due to the lack of end-groups in these cyclic species, characterizing the amount and type of cyclic oligomers formed during the polymerization is challenging. A technique to quickly analyze these byproducts is greatly desired. This is incredibly important for various research areas, such as developing new polymeric precursors for 3D printing techniques. While methods of extracting and concentrating the cyclic content exist, these are quite time consuming. There is a need for a faster analysis to characterize the absolute molecular weight distribution with high-resolution separation of cyclic oligomers.