LLB Global health solutions ltd. feasibility study and market assessment of the development of a modular manufacturing facility for local production and delivery of inactivated poliovirus vaccine (IPV) in low- and middle- income (LAMI) countries

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The proposed project intends to evaluate the market and feasibility of using a modular manufacturing facility for production of inactivated poliovirus vaccine (IPV) to be delivered as part of a routine immunisation program for low and middle income (LAMI) countries. Currently IPV is produced in private pharmaceutical companies in the “first” world and exported to LAMI countries. Due to the complex distribution systems in these countries, drug price increases dramatically as it passes through the multi-layered distribution arrangement, resulting in marginal economic benefit. The current local distribution systems also increase regulatory administrative costs and vaccine not always arrives with required quality. Local production using “standard” manufacturing plants is a challenge due to the need of large initial capital investment, and local trained workforce.This project aims to identify a novel and cost-effective way to produce IPV locally in LAMI countries using existing and proven technologies such as modular plants and disposable technologies. This approach will provide local production with reduced capital costs, through a flexible facility that has less impact on the environment through increased containment of contaminated waste generated by the facility. To test the viability of this approach, funding for a feasibility study is required. A manufacturing feasibility analysis will be the initial step of this study where cost-effectiveness of two scenarios will be evaluated against the current IPV manufacturing method. One scenario will be chosen for further market research to expose the strengths and the weaknesses of the modular production. This feasibility study will therefore be the first building block for constructing a road-map leading to an alternative manufacturing solution which is more relevant to the needs of the LAMI market with the long term vision of implementation and delivery of cost-effective and safer IPV.