With this study, we explored and demonstrated the applicability and value of orthogonal and complementary label-free technologies for enhanced serotype-independent characterization of key properties and stability profiles of rAAV5 samples. The structural characteristics of the rAAV5 start to change from 40 ☌ onward, with increasing aggregation observed. The structural stability and viral load release were also inferred from a combination of DLS, SEC–MALS, and DSC.
#Is the size malvern zetasizer radius or diameter full#
A linear range for rAAV5 size and titer determination with MADLS was established to be 4.4 × 10 11–8.7 × 10 13 cp/mL for the nominally full rAAV5 samples and 3.4 × 10 11–7 × 10 13 cp/mL for the nominally empty rAAV5 samples with 3–8% and 10–37% CV for the full and empty rAAV5 samples, respectively.
The study shows that DLS and MADLS ® can be used to determine the size of full and empty rAAV5 (27 ± 0.3 and 33 ± 0.4 nm, respectively). In this study, we evaluate the capabilities of dynamic light scattering, multiangle dynamic light scattering, and SEC–MALS for analyses of rAAV5 samples in a broad range of viral concentrations (titers) at different levels of genome loading, sample heterogeneity, and sample conditions. Importantly, there is a need for rapid analytical solutions not relying on the use of dedicated reagents and costly reference standards. Addressing these challenges requires fit-for-purpose analytics for extensive characterization of rAAV samples including measurements of capsid or particle titer, percentage of full rAAV particles, particle size, aggregate formation, thermal stability, genome release, and capsid charge, all of which may impact critical quality attributes of the final product. To develop efficient rAAV therapies produced through controlled and economical manufacturing processes, multiple challenges need to be addressed starting from viral capsid design through identification of optimal process and formulation conditions to comprehensive quality control. Recombinant adeno-associated viruses (rAAVs) are a class of viral vector that is being investigated intensively in the development of gene therapies. High Performance Liquid Chromatography can be used in drug development, as it is a dependable way to obtain and ensure product purity.Viruses are increasingly used as vectors for delivery of genetic material for gene therapy and vaccine applications.
Our Fourier-transform infrared spectrometer will help you verify/validate your formulation as well as confirm quality and verify the absence of contamination. Our technical capabilities can provide a distribution of absolute molecular weight, intrinsic viscosity as well as information on macromolecular structure, conformation aggregation and branching. GPC (Gel Permeation Chromatography) is an analytical technique in which particles/polymers are separated based on their hydrodynamic volume. Static light scattering technique will help you to determine average molecular mass of your polymer/nanoparticles as well as radius of gyration (size) and solubility (second virial coefficient). Inductively Coupled Plasma Mass Spectrometer can be used to conduct elemental/isotope analysis of over 100 different elements present at concentrations as low as 1 ppt (depending on analyte nature).ĭetermine total organic material content and the composition of the organic coating based on signature decomposition patterns using our Thermal gravimetric analysis System. Composition of inorganic/organic components Its combination of elemental specificity, sizing resolution, and unmatched sensitivity makes it extremely applicable for the characterization of particles containing elements such as Ag, Au, Ti (TiO2), and others. Single particles ICP-MS proves invaluable for detecting and sizing metallic nanoparticles at very low elemental concentrations. In addition to samples analyzed by conventional methods, NTA also possesses additional capabilities to analyze fluorescently labeled nanomaterials. The general size range varies from 40 nm – 1 µm. Nanoparticle Tracking Analysis System provides quantitative characterization data including particle size and sample concentration. Malvern Zetasizer Nano ZS is a non-destructive, simple and powerful tool for measuring hydrodynamic diameter (particle size), zeta potential (surface charge), and size distribution (polydispersity) as well as stability of the particles over the time and temperature dependence.
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Nanoparticles Characterization Particle size and surface charge
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