Discover how Zetasizer supports Quality Control and Quality Assurance by detecting aggregation early, monitoring stability, and delivering reliable, reproducible data for regulatory compliant biologics and pharmaceutical development and manufacturing.
Quality Control (QC) and Quality Assurance (QA) teams are responsible for verifying that biological products remain consistent, stable and free from unwanted aggregation or instability throughout manufacturing and storage.
However, biological products are complex. Small changes in particle size, aggregation behaviour or molecular interactions can affect product quality - and these changes often occur at the nanoscale.
To ensure consistent product performance, QC laboratories require analytical tools that deliver reliable, reproducible measurements every time.
That is why quality teams across pharmaceutical companies and research organisations rely on the Zetasizer Advance Range - providing trusted particle and molecular characterisation that supports confident quality decisions.
Using advanced dynamic light scattering and zeta potential analysis, Zetasizer provides highly sensitive insight into protein size, aggregation and molecular interactions.
With Zetasizer you can:
✔ Detect protein aggregation earlier
✔ Optimize formulation stability
✔ Understand protein interactions that drive instability
✔ Generate highly reproducible analytical data
Works with OmniTrust: Malvern Panalytical's compliance solution for the regulated environment
In biologics and advanced therapeutic development, product quality sits at the centre of everything you do. Whether you are working with monoclonal antibodies, vaccines, gene therapies, or nanoparticle formulations, every batch must meet exacting standards for safety, efficacy, and regulatory compliance.
For quality control and quality assurance teams, this creates a clear challenge. You need analytical data you can trust, across every stage of development and every production run.
Zetasizer gives you the clarity and confidence to protect product quality, maintain consistency, and meet regulatory expectations with certainty.
Protein aggregation or nanoparticle clustering can occur at any point during manufacturing, storage, or transport. Even at very low levels, aggregation can affect:
Catching these changes early is essential. Zetasizer uses dynamic light scattering to detect even subtle changes in particle size directly in solution. This allows your team to identify early signs of aggregation before they affect product performance.
With Zetasizer, you can:
✔ Detect nanoscale aggregation early
✔ Confirm particle size consistency between batches
✔ Monitor stability throughout shelf-life studies
With Zetasizer, you stay ahead of potential risks and protect the integrity of your product.
Maintaining consistency across batches is critical in biologics manufacturing. Small variations in process conditions, purification steps, or formulation environments can lead to measurable differences in particle behaviour.
Zetasizer supports precise and reliable comparability testing, helping you confirm that each batch meets your quality specifications. Using dynamic light scattering, you can compare particle size distributions between batches and ensure your processes are delivering consistent results.
With Zetasizer, you can:
✔ Verify batch-to-batch consistency
✔ Track product characteristics during process changes
✔ Support comparability and validation studies
Through Zetasizer's insights you can keep your processes under control and your standards consistently high.
Regulatory submissions rely on high-quality analytical data. When measurements are inconsistent or difficult to reproduce, it can slow approvals and introduce unnecessary risk.
Zetasizer is designed to deliver reliable and repeatable measurements that quality laboratories can depend on. Its intuitive workflows and sensitive technology help ensure consistent results across different users and instruments.
With Zetasizer, you can:
✔ Generate highly reproducible particle size data
✔ Support stability and comparability studies
✔ Build confidence in the data behind your quality decisions
Zetasizer enables you to move forward with data you trust and evidence that stands up to scrutiny.
Understanding particle size is only part of the picture. Zeta potential adds another layer of insight by revealing surface charge and molecular interactions, both of which play a key role in stability.
Zetasizer allows you to measure zeta potential quickly and reliably, helping you understand how formulation conditions influence behaviour in solution.
With this insight, you can:
✔ Explore the effects of pH, buffers, and ionic strength
✔ Identify conditions that minimise aggregation
✔ Improve solubility and formulation stability
✔ Reduce the risk of late-stage issues
Ultimately, combining particle size and zeta potential measurements with the Zetasizer, helps you to make better formulation decisions earlier in development.
Automated workflows powered by the Sample Assistant introduce a new benchmark for quality assurance and quality control across bio and pharmaceutical analysis. By standardising sample loading, measurement and data analysis, the system minimises operator variability and embeds consistency at every stage of the workflow. This level of control is essential in regulated environments, where reproducibility, traceability and data integrity are critical to both compliance and confident decision-making.
Whether you are characterising biologics, small molecules, vaccines or complex formulations, reducing variability is key to detecting subtle but meaningful changes in behaviour such as early aggregation, instability or shifts in surface charge. The Sample Assistant supports this by ensuring every sample is processed under identical conditions, strengthening method robustness and enabling more reliable comparison of results.
Built for high-throughput laboratories, the platform enables efficient screening of multiple samples and conditions without compromising analytical sensitivity. Techniques such as dynamic light scattering (DLS) and zeta potential analysis retain their precision, while automated execution ensures that QC processes remain consistent, scalable and audit-ready.
In QA and QC environments, consistency is the foundation of quality. Automated workflows not only streamline operations but also reinforce compliance by delivering standardised, reproducible data across large datasets. The result is greater confidence in product quality, more efficient workflows and stronger support for regulatory submissions and ongoing quality monitoring.
Zetasizer combines analytical sensitivity with robust, reproducible performance to support the stringent demands of quality assurance and quality control across the pharmaceutical and biopharmaceutical landscape. From early development through to manufacturing and release testing, it provides the reliable insights needed to maintain product quality and process control.
With Zetasizer, you can:
✔ Detect early-stage aggregation and instability with high-sensitivity dynamic light scattering (DLS)
✔ Measure zeta potential to assess surface charge and predict formulation and colloidal stability
✔ Identify particle interactions and molecular behaviour in complex formulations
✔ Support method development, validation and transfer with highly reproducible data
✔ Monitor critical quality attributes with confidence across batches
✔ Enable high-throughput, standardised workflows with the Sample Assistant
✔ Reduce operator variability and strengthen data integrity for audit readiness
✔ Improve efficiency in QC laboratories while maintaining analytical rigour
✔ Support regulatory compliance with consistent, traceable results
✔ Minimise risk of batch failure and costly rework
✔ Accelerate time to market through more reliable quality insights
By embedding consistency, reproducibility and control into every measurement, Zetasizer supports a proactive approach to quality, helping you ensure that every product meets the highest standards, every time.
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.