Stability screening instruments play a critical role across biologics discovery, formulation development and quality control by providing rapid, quantitative insight into the physical stability of proteins, antibodies, lipid nanoparticles and viral vectors. As biopharmaceutical molecules progress from early discovery to development and manufacturing, understanding their propensity to unfold, aggregate, self-associate, or undergo particle-size changes is essential for selecting viable candidates and designing robust formulations.

For example, in protein pre-formulation screening, stability instruments enable researchers to evaluate large numbers of samples under different solution conditions and identify factors that influence molecular behavior. These measurements support antibody candidate ranking by comparing characteristics such as thermal stability, aggregation tendency and colloidal stability. Early screening can help identify liabilities before substantial resources are committed to downstream development.

The same is true for monoclonal antibodies, which are being increasingly used in therapeutic development. Before these biologics can be commercialized, they must undergo rigorous testing, characterization, process development and quality control to ensure they maintain the required potency, efficacy and stability throughout their lifecycle. Any loss of stability can compromise therapeutic performance and may increase the risk of immunogenicity, potentially affecting both patient safety and treatment outcomes.

Like proteins and antibodies, lipid nanoparticles and viral vectors also must undergo extensive characterization to assess their physical stability and ensure consistent performance throughout development. Stability screening instruments help researchers monitor properties such as particle size, polydispersity and aggregation, providing insight into changes that may occur during formulation development, storage and handling. Early identification of changes in particle characteristics can help researchers optimize formulations, compare candidate materials and identify potential stability liabilities before advancing to later stages of development and manufacturing.

Early stability decisions shape the future of a biologics pipeline. Yet fragmented workflows, isolated measurements and misaligned data slow progress—making late-stage aggregation and stability issues exceptionally costly.

Malvern Panalytical’s new Zetasizer Core addresses this issue combining structural, colloidal and aggregation analysis in a single workflow. The instrument combines dynamic light scattering (DLS), static light scattering (SLS) and intrinsic differential scanning fluorimetry (DSF) within a single plate reader instrument.

3 in 1

Measuring DLS, SLS and DSF with one sample under the same conditions, structural stability, colloidal stability and aggregation behavior can be interpreted together rather than correlated across separate experiments. This gives formulation teams the evidence it needs to distinguish a candidate that won’t work, from one that simply needs different conditions.

Existing workflows often require samples to be transferred into instrument-specific consumables, which disrupts the workflow. Conversely, the Zetasizer Core runs on standard 96-, 384- and 1536-well plates already in use across all biologics laboratories, and slots into existing plate-handling infrastructure, robotics and LIMS workflows. This standardized format reduces inter-instrument transfers, with potential time and resource savings at sample preparation.

The Zetasizer Core can screen up to 192 samples per run at a 1°C per minute thermal ramp—twice the capacity typically achieved by existing custom sample holder stability screening instruments, which are generally limited to 96 samples.

The result is a platform that consolidates three measurements into a single run, helping teams make faster, more confident go/no-go and formulation decisions.

Minimizing late-stage instability

Ultimately, these data and decisions help minimize late-stage aggregation and stability issues.

For therapeutic proteins, by screening multiple candidates, buffers, and stress conditions in a scalable, high-throughput plate-based format, the Zetasizer Core can help scientists identify promising molecules earlier and significantly reduce the risk of late-stage instability.

For antibody development programs, the Zetasizer Core enables comprehensive, multi-parameter assessment of antibody stability by combining size, aggregation, self-association, and thermal stability readouts into a single, automated workflow.

For advanced drug delivery systems and gene therapy vectors, maintaining precise particle size and sample homogeneity is critical for therapeutic efficacy and safety. The Zetasizer Core provides high-throughput, plate-based analysis to rapidly monitor size, polydispersity, and trace aggregation. This enables development and manufacturing teams to seamlessly evaluate formulation stability, assess stability across storage conditions, and maintain strict quality control.