Viral Aggregate Testing
Viral aggregation can seriously affect the effectiveness, safety and stability of viral vectors. Creative Biogene has developed robust approaches to performing rigorous testing downstream of GMP viral vector production and prior to release, helping to optimize vector design and process flow to reduce aggregation and ensure safe and effective products for our clients.

What is Viral Aggregation?
Viral aggregation is considered as one of the major challenges in viral vector manufacturing. The tendency of viral particles to form aggregates can be defined as a survival mechanism that helps viruses to resist environmental stress and withstand degradation by disinfectants. This process is influenced by cell type and cell-associated impurities, virus type, biochemical properties of the virus (e.g. virus size and shape, isoelectric point, etc.), physicochemical factors (e.g. pH, ionic strength), and operational factors (e.g. process temperature).
Effect of Viral Aggregation on Viral Vector Stability
Viral aggregation can have several effects on the stability of viral vectors, such as:
- Viral aggregates can reduce the infectivity of viral vectors. This is because larger aggregates may be too large to pass through the cell membrane and therefore cannot infect cells effectively.
- Viral aggregation can increase the clearance of viral vectors in vivo. This is because larger aggregates are more likely to be recognized and cleared by the immune system. This can limit gene expression and the duration of therapeutic effect.
- Viral aggregates can affect the safety of viral vectors. Large aggregates have the potential to cause adverse effects, such as toxicity, inflammation or organ damage.
Viral Aggregation Testing at Creative Biogene
| Method | Description |
| Dynamic Light Scattering (DLS) | This technique measures the fluctuations in scattered light intensity caused by Brownian motion of particles. DLS can be used to monitor changes in the size distribution of virus aggregates over time. |
| Tunable Resistive Pulse Sensing (TRPS) | The TRPS method provides readings of the concentration of virus particles with different size distributions and allows the calculation of the percentage of virus aggregates, with the advantages of high resolution, fast detection and high accuracy. |
| Flow Cytometry (FC) | The FC method provides a high-throughput platform to study the aggregation behavior of viral vectors. |
Creative Biogene is committed to providing a variety of appropriate analytical methods for assessing viral aggregation to ensure consistent, high-quality products for our clients. Contact us to learn more about our viral aggregation assays and we will be happy to assist you.
* For research use only. Not intended for any clinical use.