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Dynamic Light Scattering (DLS) Technology

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Dynamic light scattering (DLS) technology is a powerful analytical tool for protein/peptide biopharmaceutical characterization, providing key information about particle size, molecular weight, aggregation state, solubility, and stability. With advanced DLS technology, CD Formulation provides reliable analytical support for protein/peptide drug development and characterization for customers around the world.

What is Dynamic Light Scattering (DLS)?

DLS, also known as photon correlation spectroscopy (PCS) and quasi-elastic light scattering (QELS), is a non-invasive technique for measuring the size and size distribution of molecules and particles in the submicron region. In the field of protein analysis, DLS can determine the hydrodynamic size of protein monomers, small aggregates in the nanometer range, and some particles in the high nanometer/low micrometer range. The technique can also be used to characterize nano-delivery vehicles and delivery systems, such as liposomes, nanoparticles, polymers, etc.

It is important to note that DLS doesn't provide particle concentration. For aggregated protein samples, DLS can only provide polydisperse information about the distribution of aggregates in the sample but detailed quantitative information about the monomer and aggregate content can't be obtained.

Dynamic Light Scattering (DLS) Principle

DSL is a particle characterization technique based on Brownian motion. A dispersion of particles in a suspension or solution sample containing Brownian motion is illuminated by a coherent light source and a portion of the light scattered by these particles is detected. Based on the fluctuations in laser intensity scattered by molecules/particles in Brownian motion, the diffusion coefficient of these particles is determined. This is then converted to particle size based on the Stokes-Einstein equation and details information about the shape and composition of these particles.

Fig. 1 Dynamic light scattering (DLS) principle.Fig. 1 DLS principle of operation. (Rodriguez-Loya J, et al., 2023)

Our Services Related to Dynamic Light Scattering (DLS)

With decades of experience supporting protein/peptide biopharmaceutical development and manufacturing, our team of highly qualified experts can provide a range of DLS-related services to accelerate the implementation and success of your project.

Our DLS systems are equipped with advanced detectors and highly sensitive data analysis systems to support all stages of your protein/peptide drug development and production - from early research to late-release testing under GMP.

At CD Formulation, we provide the following DLS-related services, including but not limited to:

Protein/Peptide Biologic Aggregate Characterization

Our scientists use DLS to rapidly measure the size distribution of particles in protein/peptide biologics and quantify the degree of aggregation in a sample. By determining the size and polydispersity index (PDI), we can identify the presence of aggregates, oligomers, or other large particles that may affect drug quality.

It is important to note that protein/peptide samples for DLS analysis have been purified to high purity using our various forms of chromatography technologies, such as affinity chromatography, ion exchange chromatography (IEC), and size exclusion chromatography (SEC).

Protein/Peptide Formulation Screening

DLS is an important research tool during the development of protein/peptide formulations, providing key data on formulation purity, such as aggregate and particle content, for comparability or stability studies.

Due to DLS's high sensitivity to detecting trace aggregates and its ability to measure small sample volumes. Our scientists use DLS technology to predict the colloidal stability of proteins in the pre-formulation research stage to screen the best formulations. Because colloidal stability will affect the aggregation tendency of proteins in formulations to a certain extent.

Stability Assessment

DLS is able to monitor the aggregation state and structural changes in protein solutions to reveal their stability profiles. Our scientists determine the optimal storage conditions and shelf life by monitoring the solubility state and aggregation degree of proteins under different conditions in real-time and quantifying the increase in particle size or aggregation to gain a deeper understanding of the stability of protein/peptide biologics.

In addition to detecting aggregation of protein/peptide biologics, performing formulation screening and stability assessment, our DLS can also be used for:

  • Protein-protein interaction studies.
  • Protein/peptide molecular weight determination.
  • Protein/peptide size and purity analysis.
  • Thermal, colloidal, and chemical stability analysis of protein formulations.
  • Characterization of protein/peptide nano-delivery systems, such as liposomes, lipid nanoparticles (LNPs), polymers, etc.

Advantages of Our Dynamic Light Scattering (DLS) Technology

  • Extremely short analysis time, accurate, reliable, and reproducible particle size analysis data can be obtained in less than a minute.
  • Small sample volume.
  • Low concentration.
  • Simple sample preparation, even native samples can be directly analyzed without sample preparation.
  • Simple operation, fully automatic measurement.
  • Size range: 0.3 – 1000 nm.
  • Highly sensitive detection of aggregates, even those that are too large or too rare.
  • Versatility: In addition to size and size distribution, other properties such as stability, stress-induced aggregation, and molecular interactions can be measured.

Custom Dynamic Light Scattering (DLS) Services

Proteins & Peptides Particle and Aggregation Characterization

Protein aggregation and particle characterization help assess the extent of protein degradation, stability, and aggregate formation in solution. We use DLS microscopy analysis technology to characterize protein/peptide aggregation to in-depth understanding of the agglomeration of the product in the development and manufacturing process, thereby helping you optimize the manufacturing process.

Nanoparticle Characterization for Proteins & Peptides Formulation

Our nanoformulation scientists use DLS technology to obtain key information about nano-drug delivery carriers and protein or peptide nanoparticles, which is very important for evaluating nanoparticle stability, biocompatibility, drug release performance, etc.

Why Choose Our Dynamic Light Scattering (DLS) Technology?

  • We have a team of experts with rich experience in performing DLS analytical method development and validation.
  • We have accumulated decades of expertise and successful project experience using DLS technology to support protein/peptide biopharmaceutical development.
  • Our laboratories are equipped with state-of-the-art equipment and technologies to support any type of protein characterization.
  • We provide flexible experimental design and customized solutions.
  • Fast turnaround time: detailed technical reports are provided within 5-7 days.

Publication

Published Data

Technology: DLS

Journal: J Pharm Sci.

IF: 2.713

Published: 2013

Results:

The authors developed a DLS-based method for online monitoring of protein solubilization, protein refolding, and aggregation near the production line. Bovine serum albumin (BSA) was first selected as a model protein to demonstrate the reliability of DLS in monitoring protein unfolding. This analytical method was then applied to monitor the recombinant fusion protein SP1 (∼40 kDa). The results were compared with those observed by size exclusion chromatography (SEC). The results showed good agreement between DLS and SEC measurements, indicating that DLS can be used as an online process analytical technique to ensure complete IB solubilization and aggregation-free refolding.

Fig. 2 Hydrodynamic radius of BSA by DLS.Fig. 2 Hydrodynamic radius of BSA upon urea denaturation monitored by DLS. (Yu Z, et al., 2013)

CD Formulation aims to provide a powerful analytical tool for protein/peptide biologics development and manufacturing. Please feel free to contact us to speak with our team of scientists and learn how our DLS technology can support your product development.

References

  1. Falke S, Betzel C. Dynamic Light Scattering (DLS): Principles, Perspectives, Applications to Biological Samples. Radiation in Bioanalysis. 2019 Jul 29;8:173–93.
  2. Rodriguez-Loya J, Lerma M, Gardea-Torresdey JL. Dynamic Light Scattering and Its Application to Control Nanoparticle Aggregation in Colloidal Systems: A Review. Micromachines (Basel). 2023 Dec 22;15(1):24.
  3. Yu Z, Reid JC, Yang YP. Utilizing dynamic light scattering as a process analytical technology for protein folding and aggregation monitoring in vaccine manufacturing. J Pharm Sci. 2013, 102(12):4284-90.
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