(131d) Towards 'perfecting' the Downstream Purification of Therapeutic Viruses

Viruses are an important new class of biotherapeutics that are being used both as vectors in gene therapy and vaccines and as tumour-killing agents in cancer immunotherapies. While there have been a number of recent advances in 'upstream' manufacturing processes (e.g. high cell density, single use bioreactors), the current ‘downstream’ purification processes are still in their “infancy”. For example, typical process yields are less than 20%. In this talk I will discuss our group’s recent and ongoing efforts in three areas to “perfect” the downstream purification process for large-scale manufacturing of therapeutic viruses. First, I will discuss the optimization and scale-up of a membrane chromatography process as an intermediate step for removal of host-cell proteins and host-cell DNA. Second, I will discuss the optimization of a microfiltration process as the final sterile filtration step. Third, I will discuss the development of economic simulations for a variety of virus manufacturing conditions, both upstream and downstream processes, using Bio-Solve Process software.