
Monoclonal Antibody Development
Measure protein size and detect aggregation to optimise stability and support biologic drug development.
Gain reproducible insight into particle behaviour in solution using the combined power of dynamic light scattering and nanoparticle tracking analysis. Detect instability earlier, understand complex systems more clearly and unlock biologics innovation with Zetasizer and NanoSight.

Biopharmaceutical development is defined by complexity. Systems such as monoclonal antibodies, protein therapeutics, vaccines and lipid nanoparticles rely on precise control of particle size, surface charge and concentration to ensure stability, efficacy and manufacturability.
These systems are inherently sensitive. Small changes in particle size distribution, zeta potential or particle concentration can significantly affect aggregation behaviour, biological interactions and overall therapeutic performance. These changes often originate at the nanoscale, long before they can be detected using a single analytical technique.
To build confidence throughout development and quality control, scientists need a more complete understanding of particle behaviour in solution.
By combining Zetasizer and NanoSight, researchers gain complementary insight into size, charge and concentration, enabling more informed decisions and reducing the risk of failure.
Works with OmniTrust: Malvern Panalytical's compliance solution for the regulated environment
Even the most carefully developed biologic formulations can fail without warning, despite appearing stable and well-characterised in early testing. What often looks like a robust system can conceal subtle nanoscale changes that quietly influence particle behaviour, stability and performance. Without the right analytical insight, these hidden instabilities can progress unnoticed, increasing the risk of failure at the point where it matters most.
Well-characterised systems can still encounter critical challenges during development, including:
• Undetected aggregation or subvisible particles
• Instability driven by surface charge interactions
• Inconsistent particle concentration and distribution
• Variability in formulation performance
• Challenges meeting quality control and regulatory expectations
These risks begin at the nanoscale, where small shifts in particle size, surface charge and population dynamics are not completely understood by single-method approaches, yet have a direct impact on stability, efficacy and reproducibility.
Formulations that appear stable early on can behave unpredictably during scale-up, storage or transport, as subtle changes in particle behaviour begin to influence performance.
Without a complete understanding, these issues remain hidden until later stages, where they are more difficult and costly to resolve, increasing development risk and putting data confidence and regulatory outcomes under pressure.
SSubtle changes in particle populations, surface charge and interaction behaviour can have a significant impact on stability, efficacy and consistency. These effects are often not detected during early development and only become apparent under real-world conditions such as scale-up, transport or long-term storage.
Zetasizer and NanoSight are designed to uncover these risks earlier.
Dynamic light scattering provides rapid, sensitive measurement of particle size distributions, while nanoparticle tracking analysis enables visualisation and measurement of individual particles to determine size and concentration. Zeta potential analysis delivers direct insight into surface charge and interaction forces.
Together, these techniques provide a more complete understanding of biologic systems, enabling earlier detection of instability, improved decision-making and reduced risk of late-stage failure.
Biologic formulations often contain heterogeneous and polydisperse particle populations. A single analytical technique cannot fully resolve this complexity.
By combining ensemble and single-particle analysis, Zetasizer and NanoSight provide a more complete and reliable view of particle behaviour. This allows scientists to characterise complex systems with greater clarity and confidence.
With Zetasizer and NanoSight, scientists can:
✔ Combine DLS and NTA for complementary insight
✔ Characterise complex and polydisperse systems
✔ Improve confidence in particle size analysis
This enables a deeper understanding of biologic formulations and supports more robust development decisions.
Stability is critical for maintaining consistent biologic performance. Surface charge plays a central role in particle interactions, aggregation behaviour and long-term formulation stability.
Zetasizer measures zeta potential to provide direct insight into these interactions. This enables scientists to predict how particles will behave in solution and optimise formulation conditions to maintain stability.
With Zetasizer, scientists can:
✔ Predict stability using zeta potential measurements
✔ Reduce aggregation risk in sensitive biologics
✔ Optimise buffers and excipients for robust formulations
This insight supports the development of stable, reproducible biologic products.
Particle concentration and distribution are critical parameters in biologics development and quality control. Variability in these factors can impact dosing, efficacy and batch-to-batch consistency.
NanoSight enables direct visualisation and measurement of individual particles, providing accurate concentration data alongside size distribution. When combined with Zetasizer measurements, this creates a complete picture of particle behaviour in solution.
With Zetasizer and NanoSight, scientists can:
✔ Measure particle concentration with precision
✔ Understand distribution and population dynamics
✔ Link particle properties to formulation performance
This ensures greater control over biologic systems throughout development and manufacturing.
Consistent workflows are essential for generating reliable data in biologics development and quality control. Small variations in sample handling or measurement conditions can introduce variability that obscures critical insight.
The Sample Assistant enables automated, SOP-driven workflows that standardise sample preparation, measurement and data collection. This ensures that every sample is analysed under controlled and reproducible conditions.
In high-throughput environments, automation allows multiple formulations to be analysed efficiently without compromising analytical sensitivity. Dynamic light scattering, zeta potential and nanoparticle tracking measurements remain robust, while reproducibility is improved across users and sites.
By embedding consistency into every stage of analysis, automated workflows support high-quality data generation and enable confident comparison of biologic formulations.
Zetasizer and NanoSight combine analytical sensitivity, reproducibility and complementary techniques to address the complex challenges of biologics development. From early research through to quality control and manufacturing, they provide the insight needed to understand particle behaviour and reduce development risk.
With both the Zetasizer and NanoSight, you can:
✔ Measure particle size across a wide dynamic range using DLS
✔ Analyse zeta potential to understand surface charge and predict stability
✔ Determine particle concentration and distribution using NTA
✔ Detect early-stage aggregation and subvisible particles
✔ Characterise complex and heterogeneous biologic systems
✔ Generate highly reproducible, audit-ready data
✔ Support robust quality control and assurance workflows
✔ Compare formulation variables including pH, buffers and excipients
✔ Enable high-throughput, standardised analysis with the Sample Assistant
✔ Reduce the risk of late-stage failure and reformulation
By combining the two instruments and delivering a complete and reproducible understanding of particle size, charge and concentration, Zetasizer and NanoSight give you the clarity to identify risk earlier, reduce uncertainty and make confident decisions faster.
With deeper insight at every stage, you can avoid costly delays, strengthen your data and move your biologics forward with greater speed, control and confidence.

Measure protein size and detect aggregation to optimise stability and support biologic drug development.

Characterise nanoparticle size and surface charge to optimise delivery efficiency and stability.

Verify particle size and stability to maintain product quality and regulatory compliance.

Analyse vesicle size and aggregation to support emerging therapeutic applications.

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.