Aggregates
Aggregation of biomolecules is a major problem in biomedical research and biotechnology. Aggregates formed within the body can be toxic and can lead to such conditions as Alzheimer's and Parkinson's diseases. Formation of aggregates in biotherapeutics can result in a loss of efficacy, changes in biodistribution and bioavailability, and even the induction of autoimmune diseases. Aggregates can also lead to unsightly turbidity, or "cloudiness," in biotherapeutics, sometimes requiring clumsy point-of-use filters or even rendering a product completely unmarketable.
Detecting, quantifying, and characterizing aggregates early in the development cycle is the key to minimizing aggregation problems. Typically, an understanding of the cause of the aggregation can point to changes in the manufacturing process or formulation which can attenuate or even eliminate aggregation completely. Traditionally, a number of analytical techniques are available for studing aggregation, including:
- Size exclusion chromatography (SE-HPLC or SEC)
- Flow field-flow fractionation (flow FFF)
- Gel electrophoresis
- Static light scattering (SLS, or MALS)
- Dynamic light scattering (DLS or QELS)
- Turbidimitry
At Analytical Ventura, we make use of all of these analytical methods to detect, quantify, and characterize aggregates. In addition, our colleagues make use of complementary methodologies, such as
- Sedimentation velocity analytical ultracentrifugation (Sd Vel AUC)
- Sedimentation equilibrium analytical ultracentrifugation (Sd Eq AUC)
In addition to these established techniques, we also develop novel methods which are suitable for addressing aggregation problems in quality, process-development, and manufacturing environments. We are happy to apply our years of experience with aggregates to identify the optimal way to detect, understand, and attenuate aggregation in your biotherapeutic product.
