Delivering reliable, reproducible insight into vector behaviour in solution using Zetasizer particle size and zeta potential analysis to accelerate gene therapy development and reduce risk.
Improve Gene Therapy and Viral Vector Development with Zetasizer Dynamic Light Scattering, MADLS and Zeta Potential Analysis for Confident Particle Characterisation and Formulation Stability.
Gene therapies and viral vector-based medicines are transforming the treatment of inherited disorders, cancers and rare diseases. However, the complexity of viral vectors, including adeno-associated viruses (AAVs), lentiviruses and other delivery systems, presents significant analytical challenges. Maintaining particle integrity, minimising aggregation and ensuring consistent formulation stability are essential for product efficacy, manufacturing success and regulatory approval.
Many conventional analytical techniques only identify instability after measurable changes have already occurred. Zetasizer enables earlier insight into particle behaviour, allowing scientists to detect formulation changes before they compromise product quality or manufacturing performance.
Zetasizer helps you stay ahead of instability, giving you the insight needed to optimise gene therapy and viral vector development with confidence.
With Zetasizer you can:
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Developing safe and effective gene therapies requires exceptional control over viral vector quality throughout development and manufacturing. Small changes in formulation, purification or storage conditions can influence particle integrity, stability and biological performance, often without immediate detection.
These issues often emerge during scale-up, technology transfer or commercial manufacturing, when process deviations become significantly more expensive to correct.
Earlier insight into particle behaviour can make all the difference.
Many gene therapy programmes encounter issues during later stages such as scale-up, storage, or clinical translation. Often, the root cause lies in subtle changes in particle size, aggregation behaviour, or interparticle interactions that were not identified early.
These small variations can compromise stability, reduce delivery efficiency, or introduce safety concerns. Because they develop gradually and at the nanoscale, they are easily missed without the right analytical tools.
Zetasizer enables early detection of these critical changes. Using dynamic light scattering (DLS) to measure particle size and electrophoretic light scattering to determine zeta potential, it provides direct insight into vector behaviour in solution. This allows researchers to identify instability early, optimise formulations with confidence, and make better-informed decisions throughout development.
Aggregation is one of the most significant risks in viral vector development. Even low levels of aggregation can reduce infectivity, alter biodistribution and compromise therapeutic efficacy while increasing manufacturing variability. Other analytical techniques may not detect subtle aggregation until product quality has already been affected.
Dynamic Light Scattering provides rapid and highly sensitive particle size analysis, enabling scientists to identify early aggregation and monitor changes throughout formulation development, purification and storage. Detecting these changes earlier supports more confident process optimisation and reduces the risk of failed batches.
Adaptive Correlation enhances measurement quality when analysing unstable, noisy or highly concentrated viral vector samples. This increases confidence in difficult measurements while providing robust analytical data from challenging formulations.
With Zetasizer you can:
Early aggregation detection enables scientists to optimise viral vector formulations before instability affects efficacy, manufacturing consistency or regulatory confidence.
Maintaining stable viral vector formulations is essential for preserving biological activity throughout manufacturing, transportation and storage. Small formulation changes can significantly influence particle stability, aggregation behaviour and long-term product performance, making formulation optimisation a critical stage of development.
Zeta Potential measures the electrostatic potential at the "slipping plane” of the particle, allowing scientists to predict colloidal stability, compare formulation robustness and identify stability windows that support long-term storage and manufacturing. These measurements provide valuable insight into how formulation variables influence aggregation risk and product consistency.
Supporting formulation decisions with quantitative stability data enables development teams to improve robustness while reducing unnecessary experimentation.
With Zetasizer you can:
Understanding the relationship between surface charge and formulation stability helps scientists develop viral vector products that perform consistently throughout the product lifecycle.
Gene therapy formulations often contain complex particle populations that include intact viral vectors, empty capsids, aggregates and formulation-related particles. Understanding these heterogeneous populations is essential for process optimisation, quality control and manufacturing consistency.
MADLS enhances conventional Dynamic Light Scattering by combining measurements from multiple detection angles to improve particle population resolution. This enables greater confidence when characterising broad particle size distributions and improves differentiation between multiple particle populations within complex formulations.
Improved particle resolution supports more informed formulation development and provides scientists with a deeper understanding of how process changes influence viral vector quality.
With Zetasizer you can:
By providing greater visibility into particle populations, MADLS helps scientists optimise manufacturing processes while improving confidence in analytical results.
Reliable viral vector characterisation depends upon consistent analytical workflows as much as advanced instrumentation. Manual processes and operator variability can introduce unnecessary uncertainty into particle characterisation, particularly across multiple laboratories or manufacturing sites.
Sample Assistant standardises biologics characterisation using SOP-driven workflows and intelligent automation. Laboratories can reduce user-to-user variation, accelerate onboarding and ensure every measurement follows validated analytical methods, improving reproducibility across research, development and quality control.
With Sample Assistant you can:
By reducing workflow variability while supporting validated analytical methods, Sample Assistant helps laboratories generate trusted particle characterisation data with greater efficiency and confidence.
Delivering safe, effective and reproducible gene therapies depends on understanding particle behaviour throughout development and manufacturing. Combining Dynamic Light Scattering, Adaptive Correlation, MADLS and Zeta Potential analysis, Zetasizer provides the analytical confidence needed to detect instability earlier, optimise formulations and support robust manufacturing processes.
With Zetasizer you can:
Whether you are developing AAV therapies, lentiviral vectors or next-generation gene delivery platforms, Zetasizer provides the analytical insight needed to accelerate development, improve formulation robustness and deliver confident, reproducible results throughout the gene therapy development lifecycle.
Measure protein size and detect aggregation to optimise stability and support biologic drug development.
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Verify particle size and stability to maintain product quality and regulatory compliance.
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Characterize protein stability, aggregation and molecular behaviour to ensure efficacy and shelf life.
Analyse particle size and stability of antigens and delivery systems for effective vaccine performance.
Measure viral vector size and stability to ensure safe and effective gene delivery.
Understand nanoparticle size and surface properties to control drug release and targeting.
Measure size, zeta potential and concentration using DLS and NTA. Detect instability early and optimise biologics with Zetasizer and NanoSight.
The basics of Dynamic Light Scattering and electrophoretic light scattering will be discussed. I will review the Dynamic Light Scattering acronyms, i.e what is meant by NIBS and MADLS.
ZetaClass is a comprehensive webinar series on dynamic and electrophoretic light scattering where our experts walk you through the basic measuring principles, data interpretation, and tests performed to gauge data quality.
Join us as we unveil the new and expanded Zetasizer range: Zetasizer Advance. Dr Mike Kaszuba will introduce the new range and help you to pinpoint which system best fits your particle characterization requirements.
This webinar discusses some basic fundamentals of light scattering science and also common misconceptions about light scattering methods
In this webinar, you will learn about developing reliable and effective methods for dynamic light scattering (DLS) and electrophoretic light scattering (ELS) measurements using the Zetasizer Advance instrument. The presentation is geared toward users of DLS and ELS instruments who want to deepen their understanding of method development.
This webinar will explore how the Dynamic Light Scattering (DLS) technique, utilized by the Zetasizer Advance series, ensures compliance with United States Pharmacopeia (USP) guidelines, specifically USP 430.
This webinar will discuss each of the sections contained in United States Pharmacopeia (USP) 432 and what it means for users of Malvern Panalytical’s Zetasizer range of instruments who measure zeta potential in their workflow.
Join us to learn how to assess the quality of your data collected on the Zetasizer Advance instrument. Together we will go through real examples of data from particle size measurements that use Dynamic Light Scattering (DLS) and zeta potential measurements obtained with Electrophoretic Light Scattering (ELS) assessing data quality and sharing tips on how to improve confidence in the results.