Development of a Commercially Scalable Oncolytic Vaccine Production Process for Viral Immunotherapy

Advanced Therapy Medicinal Products are a new treatment modality in the pharmaceutical industry. APC Ltd, Dublin, is one of the world’s leading pharmaceutical process engineering research and development companies. Recently, APC Ltd. developed a scalable manufacturing process for an ATMP, a novel oncolytic vaccine produced in adherent cells. The initial manufacturing process in place was not scalable or commercially viable. APC Ltd. developed a scalable microcarrier based upstream and downstream process. During process development, APC Ltd. overcame the known production challenges with titre recovery and impurity clearance. The scaled process resulted in a 400 % increase in virus production per cell with an impurity profile on target. The number of doses produced was 16 times higher than the previous process with an 8-fold cost reduction per dose and the medicine to patient time was accelerated 3-fold. As a result, more patients could receive this novel advanced treatment option.