Detect mAb aggregation and particle heterogeneity early. Optimise stability and reduce risk with NanoSight Pro
Monoclonal antibodies are central to modern biologic therapeutics, supporting treatments across oncology, autoimmune disease and chronic inflammatory conditions. Their success depends on maintaining precise structural integrity and colloidal stability to ensure consistent efficacy and safety.
However, monoclonal antibody systems are inherently complex and sensitive. Small changes in formulation, processing or storage conditions can drive aggregation and particle formation. These changes often begin at the nanoscale, long before they can be detected using conventional analytical techniques.
To move forward with confidence, scientists need analytical tools that provide clear, reproducible insight into particle populations in solution. That is why biologics researchers across pharmaceutical and biotechnology organisations rely on Malvern Panalytical's NanoSight Pro, delivering particle-level characterisation data they can trust throughout development.
With NanoSight Pro you can:
✔ Visualise and quantify individual particles to reveal true sample heterogeneity
✔ Detect low-level aggregation early to reduce development risk
✔ Generate reproducible, quantitative data to support confident decision-making
Works with OmniTrust: Malvern Panalytical's compliance solution for the regulated environment
Even the most carefully engineered monoclonal antibody formulations can unravel in the later stages of development, not because of obvious flaws but due to subtle, often invisible instabilities that quietly take hold beneath the surface.
These challenges rarely announce themselves early. Instead, they emerge from complexities that are difficult to detect and even harder to predict:
What makes these risks particularly challenging is their origin at the nanoscale. At this level, changes occur long before visible signs appear or traditional analytical techniques can reliably detect them. By the time instability becomes measurable, the impact may already be significant, affecting efficacy, safety, and ultimately the success of the therapy.
Understanding and addressing these hidden dynamics is not just a technical challenge. It is essential to de-risk development and ensure robust, reliable biologics from lab to patient.
Subtle changes in particle size distribution and aggregation behaviour can have a significant impact on biological activity, pharmacokinetics and immunogenicity. These instabilities are often missed during early development and only become apparent under real-world conditions such as manufacturing scale-up, storage or transport.
NanoSight Pro is designed to uncover these risks earlier in development.
Using nanoparticle tracking analysis, NanoSight Pro visualises and measures individual particles in solution. This enables detection of low-level aggregation, resolution of multiple particle populations and accurate measurement of particle concentration by size. The result is earlier insight, more informed decision-making and reduced risk of late-stage failure.
Aggregation is a critical quality attribute in monoclonal antibody development. Even low levels of sub-visible particles can reduce therapeutic activity and increase the risk of immunogenic responses.
NanoSight Pro provides direct visualisation and quantification of individual particles, enabling detection of aggregation that may be missed by ensemble techniques.
With NanoSight Pro, monoclonal antibody researchers can:
✔ Detect low-abundance aggregates with high sensitivity
✔ Measure particle size distributions without masking effects
✔ Quantify particle concentration across defined size ranges
This enables earlier identification of instability and improved control of product quality.
Formulation variables such as pH, ionic strength and excipient composition play a critical role in monoclonal antibody stability. Small changes can alter protein interactions and drive aggregation.
NanoSight Pro provides detailed insight into how these variables influence particle behaviour, enabling precise optimisation of formulation conditions.
With NanoSight Pro, you can:
✔ Evaluate the impact of formulation changes on aggregation behaviour
✔ Compare stability across multiple candidate formulations
✔ Identify conditions that minimise particle formation and variability
This supports the development of robust, stable monoclonal antibody formulations.
Monoclonal antibody formulations often contain multiple co-existing particle populations that influence stability and performance. Traditional techniques can struggle to resolve this complexity.
NanoSight Pro tracks individual particles in real time, providing a detailed view of heterogeneous systems and how they evolve under different conditions.
With NanoSight Pro, biologics developers can:
✔ Distinguish between multiple particle populations in a single sample
✔ Observe particle behaviour dynamically in solution
✔ Generate high-resolution, defensible analytical data
This deeper understanding enables better control of biologic systems throughout development.
NanoSight Pro combines particle-level sensitivity with reproducible analysis to address the complex challenges of monoclonal antibody development. From early-stage research through formulation optimisation and stability testing, it provides the insight needed to understand particle heterogeneity and reduce development risk.
With NanoSight Pro, you can:
✔ Measure particle size and concentration using nanoparticle tracking analysis
✔ Visualise individual particles directly in solution
✔ Detect low-level aggregation missed by traditional methods
✔ Resolve complex, heterogeneous particle populations
✔ Monitor particle behaviour across formulation and process conditions
✔ Generate highly reproducible and quantitative data
✔ Identify instability earlier in development
✔ Optimise formulations with greater precision
✔ Reduce the risk of late-stage failure and reformulation
✔ Accelerate biologic development timelines
By delivering clear, reproducible insight into monoclonal antibody particle behaviour, NanoSight Pro enables scientists to make better decisions earlier, reduce risk and advance biologic development with confidence.
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