Focus on Pharma: Biophysical Characterization of an RSV Antigen at Low Temperatures
Respiratory Syncytial Virus (RSV) infects millions of people each year causing disease in the lungs and respiratory tract. For individuals with developing or compromised immune systems (such as infants or older adults), RSV infection can result in hospitalization or death. Proteins on the surface of the viral membrane can be targeted by the adaptive immune system. Furthermore, their function is critical to viral infection making them an attractive potential candidate for vaccine development. Of particular interest is the thermostability of an antigen at low temperatures in liquid formulation because it has been observed that the antigen exhibits reduced in vitro potency of a critical epitope more quickly when stored at 5 °C than 25 °C.
What will you learn?
- Physical stability of biologics, including vaccines, is a critical factor impacting product quality, potency and storage conditions.
- Detailed and robust characterization by complementary and orthogonal analytics is employed to profile stability of biologics and to study and address mechanisms of degradation.
- Differential Scanning Calorimetry (DSC) is one of the key biophysical techniques used for detailed characterization of thermal stability of biologics.
- DSC provides first principle physicochemical characteristics of thermal unfolding of a protein, such as vaccine antigen, and, along with complementary data on structure and homogeneity in solution, informs protein engineering and supports process and formulation development.