Dynamic Light Scattering

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Dynamic Light Scattering

Method Introduction

Dynamic light scattering (DLS) is a non-invasive, quick, and robust technique for determining the hydrodynamic size of molecules or particles. Based on intensity fluctuations of laser light scattered by the molecules/particles moving in Brownian motion, the diffusion coefficient is determined and converted to particle size via the Stokes-Einstein equation.

The particle size range of DLS depends on the properties of the analyzed species, such as refractive index or density, as well as the surrounding formulation, mainly the viscosity. A size range from about 1 nm to several µm can be covered for protein monomers and aggregates. Particle concentrations cannot be obtained by DLS. For aggregated protein samples, DLS results can show that the aggregate distribution in the sample is polydisperse. Still, obtaining detailed quantitative information on monomer and aggregate content is not feasible.

Applications

DLS can determine the hydrodynamic size of protein monomers, small aggregates in the nanometer range and partially also particles in the high nanometer/low micrometer range. The technique can also be employed to analyze colloidal systems, such as liposomes, nanoparticles, polymers and virus-like particles.

Quality and Biosafety Level

We provide all our analytical services with the highest quality standards. Experienced scientists carry out each project, and a scientific reviewer comprehensively checks every report or data presentation.

We offer this technology with the following quality and biosafety levels:

R&D level

We offer this method under R&D. Our GRP system assures the highest-quality research standards.

Up to biosafety level 2

This method can be applied to nucleic acids, viruses, cells, viral vectors, including lentiviruses and more.

Dynamic Light Scattering (DLS) Frequently Asked Questions (FAQs)

  • Dynamic Light Scattering is an analytical technique used to determine the hydrodynamic size of particles or molecules in suspension. It measures fluctuations in laser light scattering caused by Brownian motion and calculates particle size using the Stokes-Einstein equation.

  • DLS is capable of measuring particles from approximately 1 nanometer to several micrometers in diameter. The effective size range depends on the properties of the particles (e.g., refractive index, density) and the formulation matrix, including viscosity.

  • DLS is widely used to characterize protein monomers, protein aggregates, virus-like particles (VLPs), nanoparticles, polymers, colloids, and liposomes. It is suitable for both biologic and synthetic systems.

  • While DLS can detect polydispersity and indicate the presence of aggregates, it cannot quantitatively resolve monomer and aggregate content. It provides a distribution profile rather than discrete quantification.

  • Coriolis offers DLS analysis at the research and development (R&D) level under GRP (Good Research Practice) standards. The method is executed by experienced scientists and reviewed for scientific integrity.

  • Yes. DLS at Coriolis can be applied to samples up to biosafety level 2 (BSL-2), including viral vectors such as lentivirus, as well as nucleic acids and other gene therapy products.

  • DLS offers quick, non-destructive sizing of nanoparticles in suspension. However, it is less effective than orthogonal techniques like nanoparticle tracking analysis (NTA) or resonant mass measurement (RMM) for detailed quantification or heterogeneous samples.

  • DLS is limited in its ability to resolve highly polydisperse samples with multiple particle size populations. In such cases, complementary techniques such as asymmetrical flow field-flow fractionation (AF4) or micro-flow imaging (MFI) may be more informative.

  • Coriolis combines high-quality DLS capabilities with deep expertise in biologics formulation and particle characterization. Our tailored analytical strategies support robust data generation for product development and regulatory submissions.

Analytical Method Development, Qualification and Validation

For common sample types, we can often apply standardized methods with little setup effort. However, when needed, our experienced analytical experts create or optimize custom methods tailored to your active pharmaceutical ingredient, product type and development phase.

Method Development

Our method development approach tailors sample preparation, method settings and data analysis to the needs of your project and sample.

We include representative samples and, where available, suitable reference standards and stressed/degraded materials, allowing our analytical scientists to design a highly suitable, stability-indicating, robust and repeatable method. Upon request, we will compile a detailed description of the method for your records.

Method Qualification

Method qualification is the initial assessment of an analytical procedure’s performance to show its suitability for its intended purpose.

During method qualification, our analytical scientists perform documented testing demonstrating that the analytical procedure meets criteria in several categories. Criteria may include factors such as repeatability, specificity and robustness. We compile a qualification plan and report, including all relevant data.

Method Validation

Under GMP conditions, method validation confirms that an analytical procedure’s performance suits its intended purpose. Depending on the method’s scope, a broad range of method characteristics, such as specificity, accuracy, precision, limit of detection/limit of quantification (LOD/LOQ), linearity and range, is considered.

During method validation, our analytical scientists perform documented testing demonstrating that the analytical procedure consistently produces a result that meets the predetermined acceptance criteria. We compile a validation plan and report that includes all relevant data.

Depending on the development phase, a fit-for-purpose validation approach can be offered, adjusting the validation required efforts in a phase-appropriate way to meet the method’s needs.

Method Verification

Compendial method verification confirms that a compendial method (e.g., from Ph. Eur. or USP) is suitable and reliable for its intended purpose under the specific conditions of the laboratory.

Unlike full method validation, compendial method verification is often considered a partial validation since the method has already undergone extensive testing and validation during its inclusion in the compendium. The extent of method verification depends on the type of method.

During method verification, our analytical scientists perform documented testing demonstrating that the developed analytical method performs adequately for the specific product or matrix being tested and within the specific laboratory where the method will be employed.

Talk to Our Experts or Request a Quote

Our expert team is ready to answer your questions and guide you to the services best suited to your program’s modality, stage and challenge. If your needs are well-defined, we’ll begin the quotation process.

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Particle Characterization – Overview Analytical ultracentrifugation (SV-AUC / SE-AUC) Asymmetrical flow field-flow fractionation (AF4) Backgrounded membrane imaging (BMI) Electrical sensing zone (ESZ) / microfluidic resistive pulse sensing (MRPS) Fourier-transform infrared (FTIR) microscopy Micro-flow imaging (MFI) Hollow fiber flow-field-flow fractionation (HF5) Imaging flow cytometry (IFC) Light microscopy (LM) Light obscuration (LO) Mass photometry (MP) Micro-flow imaging (MFI) Nanoparticle tracking analysis (NTA) Nephelometry / turbidity Quantitative laser diffraction (qLD) Resonant mass measurement (RMM) Scanning electron microscopy coupled energy-dispersive x-ray spectroscopy (SEM-EDX) Semi-automated visual inspection (SAVI) Total holographic characterization (THC) Transmission electron microscopy (TEM) Visual inspection

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