Sabin inactivated polio vaccine upstream process development using fixed-bed bioreactor technology

Abstract

Eradication of polio disease remains a challenge for countries with limited health-care infrastructure. Regional vaccine production is expected to secure a sustainable and equitable availability of vaccines supporting the polio eradication end-game. Regional manufacturing of Inactivated Polio Vaccines based on the attenuated Sabin strains and using an isolator-based contained micro-facility is expected to avoid any potential risk of shortage of polio vaccines in the future, ensure equitable access to sufficient doses of IPV while securing a safe manufacturing environment. However, polio vaccine production requires biosafety level 3 containment and is complicated by the restrictions imposed from the adherent nature of the virus-producing Vero cell line. To overcome these issues that have hampered regional polio vaccine production so far, at Batavia Biosciences we developed an inactivated polio vaccine production process based on the polio Sabin strains in a contained microfacility. By incorporating a tangential flow filter coupled to a fixed-bed bioreactor with a large attachment surface area (150 m²), we could increase process efficiency and reduce the production footprint allowing for regional demand-driven production. The reduced square meters of the manufacturing site that handles the live virus were achieved by integrating the fixed-bed bioreactor with the concentration step (TFF). The increased efficiency was realized by using less resources, fully disposable virus production, and a down- and up-scalable process depending on vaccine demand. The here-developed scalable production process with reduced production footprint is considered a useful and cost-effective method for regional vaccine production, for example in pandemic preparedness efforts to efficiently contain virus outbreaks.