Potency Assays

Modern vaccine production is generally accomplished using live viruses throughout the research, development, and manufacturing processes. At each of these stages, analytical monitoring of viral infection is important to help ensure predictable infection and expansion, maximum yield, and safety parameters, especially for cell culture based processes. The potency of a live virus vaccine (LVV) is one of the most critical measurements of efficacy. Existing methods to measure the potency of viruses include plaque and TCID50 assays, both of which have very long lead times and cannot provide real-time information on the quality of the vaccine during large-scale manufacturing.

Some vaccines are manufactured using viral vectors such as adenovirus, vesicular stomatitis virus (VSV), or measles virus. Incorporating additional genes in these vectors can result in poor infectivity rendering them ineffective for drug or vaccine development. Therefore, it is important to rapidly screen the infectivity of candidate viruses, which can be a tedious and time-consuming task when relying on traditional infectivity assays. In contrast, Radiance® can quickly assess the infectivity of recombinant adenovirus after as little as 24 hours of incubation with the target cells. Production can be monitored using Radiance® via sequential aliquots or through continuous monitoring of the infection and production process.