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.
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.
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 DLS principle of operation. (Rodriguez-Loya J, et al., 2023)
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:
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).
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.
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:
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 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