Development and formulation of biopharmaceuticals require characterization to help determine how these therapies will perform outside the lab. Many properties cannot be accurately visualized—or in many cases visualized at all—by traditional means. Yet there are a variety of measurements that can indicate size, diversity, and concentration of particles in solution, as well as how they may interact in solution.
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In this podcast, Richard Chung, a Product Manager at Wyatt Technology, describes the benefits of the ZetaStarTM Instrument.
Whether formulating lipid nanoparticles for gene therapy or novel vaccines, developing proteins for more stable therapies, or investigating novel polymers, it is important to know not only their individual characteristics, but how they interact with other particles and solvents in the surrounding environment. Measurements of size, particle concentration, and zeta potential, as well as polydispersity and turbidity, are critical to understanding many aspects of samples such as complex molecules, including stability, aggregation, and degradation.
The ZetaStarTM Instrument allows formulation and development labs to make walk-up or automated measurements of size, concentration, and zeta potential of particles, from angstroms to microns, easily and reliably in seconds.
Many instruments measure only a single parameter—requiring separate measurements, on separate instruments, to achieve the desired data on a given sample. This, in turn, necessitates using greater amounts of sample, and spending considerably more per-sample hands-on time. Wyatt Technologies’ ZetaStar offers a distinct advantage in productivity by performing measurements of simultaneous dynamic light scattering (DLS) and either static light scattering (SLS) or electrophoretic light scattering (ELS) to interrogate different parameters at the same time.
DLS, SLS, and ELS use complementary means to gather information about particles in a solution. Together they can provide a comprehensive characterization of particle size, zeta potential, and concentration, among a host of other attributes. In addition to getting data faster from less sample, simultaneous measurement allows for more accuracy by correlating orthogonal readouts.
Versatile and powerful instruments can be saddled with more complex operational procedures. But that does not need to be the case.
The ZetaStar is equipped with the onboard DYNAMICS Touch software, accessible on a built-in touch screen. The app allows walk-up novice or casual users to immediately collect five critical parameters in a single workflow: size, polydispersity, particle concentration, zeta potential, and turbidity, displaying the data on the screen. The software guides non-expert users through the process, providing feedback on data quality. Reports can be exported on a flash drive, or sent to a cell phone or through a network.
Data can also be imported into the connected PC-resident DYNAMICS software application for more in-depth analysis, including graphic representations plotting zeta potential against other parameters like pH or concentration, for example, or comparing data generated at different times or on different instruments. Data can also be presented in table format, allowing, for example, for straightforward presentation of statistical analyses.
The DYNAMICS software also controls autosamplers and pumps, allowing for walk-away measurement of multiple samples.
The ZetaStar is one of the few instruments on the market designed to be used with or without an autosampler and pump to measure size and zeta potential.
Only 2 uL of sample are needed to obtain reliable DLS or SLS data, and 65 uL for ELS. A variety of low-volume cuvettes—as small as 2 uL—are available, and results can be obtained in seconds. Yet with cuvettes, samples need to be laboriously transferred, and cuvettes should be cleaned between samples to avoid potential carryover.
When multiple samples need to be measured, DLS/ELS can be performed using an autosampler for fully automated—unattended—operations. This reduces the need for active labor associated with operating the instrument in manual mode and increases productivity by allowing other tasks to be performed during the time saved.
Development of vaccines, gene therapies, and biopharmaceuticals—including their carriers—requires more than just a seeing what parameters are displayed in a buffer. It is also important to know how stable these complex macromolecules will be under different conditions such as the more physiologically relevant high salt solutions. Yet bubble formation due to electrolysis under high salt conditions can disrupt the field and make the system noisy, leading to erroneous results.
The ZetaStar’s flow cell can be pressurized along the full path to quash any bubbles that might form. In addition, the flow cell’s platinum electrodes are less reactive than common electrodes, resulting in less surface chemistry and the degradation that results from it, and more reliable characterizations.
ZetaStar with built-in touch software enables any scientist to perform walk-up or automated measurements of key developability parameters of complex macromolecules in a single workflow, using precious little material in the shortest amount of time.