December 8, 2021
In this E-book, we present how light scattering can be used to characterize lipid nanoparticles (LNPs) in the product and process development stages.
November 23, 2021
In this white paper, we describe a validated FFF-MALS method in-line with technical specification ISO/TS 21362 for the analysis of lipid-based nanoparticles (LNPs) encapsulating siRNA and mRNA.
November 15, 2021
Thermostability screening by means of a temperature ramp is a common approach to assessing the aggregation propensity of different candidate molecules and formulation conditions. In this application note, we discuss how to screen by SEC-MALS and DLS.
August 25, 2021
Composition-gradient multi-angle light scattering (CG-MALS) provides easily interpreted data for complicated macromolecular interactions. Here we show how a simple protocol provides information-rich data with a completion time of a few hours.
August 24, 2021
AAV characterization and stability screening are achieved with multi-angle light scattering coupled to separation methods and high-throughput dynamic light scattering.
June 4, 2021
This white paper describes the technical innovations of the new Eclipse field-flow fractionation system and how they help the FFF-MALS user achieve new levels of performance, with less effort, in characterizing macromolecules, nanoparticles, nano-emulsions and other analytes in solution/suspension with sizes from 1 to 1000 nm.
June 3, 2021
While conventional calibration for gel permeation (GPC) or size-exclusion chromatography (SEC) is useful, there are inherent disadvantages in this type of analysis that introduce experimental error. This uncertainty may cast serious aspersions on the rigour and utility of the results. Multi-angle light scattering (MALS) detection is quite simple to add to an existing chromatography system and can help overcome the challenges faced with single detector chromatography and conventional calibration-based methods. An alternative separation technique called asymmetric flow field-flow fractionation (AF4) offers tunable, column-free fractionation.
May 25, 2021
Biopharmaceuticals, comprising monoclonal antibodies, antibody-drug conjugates, recombinant or fusion proteins, and bispecifics, among others, have recently gained commercial success and are rapidly changing the therapeutic landscape. Due to their large size and complex structures, characterizing these biotherapeutics requires robust and demanding analytical techniques. Often, traditional methods used to characterize proteins fail to deliver on either the sensitivity required or the speed desired to accelerate the drug development pipeline.
May 5, 2021
Real-time MALS (RT-MALS) represents a new paradigm in PAT: instead of process parameters, it directly monitors product attributes. Implementation of RT-MALS promises to speed up process development and scale-up, increase yieldduring production and enhance end-product quality.
April 19, 2021
This document lists key publications using high-throughput dynamic and static light scattering in formulation development of therapeutic proteins.
January 8, 2021
This document lists key publications using high-throughput dynamic light scattering (HT-DLS), size exclusion chromatography combined with multi-angle light scattering (SECMALS), and field flow fractionation combined with MALS (FFF-MALS) to characterize various gene delivery nanoparticles including viral vectors/virus like particles (VLPs), lipid nanoparticles (LNPs), extracellular vesicles (EVs), and other gene carriers.
January 4, 2021
This note discusses the characterization and comparison of conformational properties of hyperbranched macromolecules from two Acacia gum varieties, A. senegal and A. seyal, using SEC-MALS-IV combining MALS with online viscometer and refractive index detector.