Therapeutic proteins, such as antibodies, hormones, enzymes, growth factors, etc., are highly successful in the clinic and are currently a major focus of the pharmaceutical industry. However, formulation of stable protein drugs is challenging, as most proteins are sensitive to sunlight, high and low temperatures, pH, and so on. Exposure to these conditions can lead to irreversible denaturation or to aggregation. Protein aggregates lead to a loss of biological activity of the drug and can cause severe adverse reactions in the patients.
Protein aggregation can be monitored rather simply by using light scattering techniques. Particle size and particle mass can be measured quickly and conveniently by using dynamic and static light scattering, respectively. Furthermore, the transmittance can also provide a very rapid indication of the extent of aggregation. All three of these techniques are available in the one instrument with the Litesizer™ 500.