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

拟议项目旨在评估使用模块化生产设施生产灭活脊髓灰质炎病毒疫苗（IPV）的市场和可行性，该疫苗将作为中低收入（LAMI）国家常规免疫计划的一部分提供。目前，IPV由“第一”世界的私营制药公司生产，并出口到LAMI国家。由于这些国家复杂的分销系统，药品价格在经过多层分销安排时急剧上涨，导致边际经济效益。目前的地方分配系统还增加了管理行政费用，而且疫苗并不总是以所需的质量运抵。由于需要大量的初始资本投资和当地训练有素的劳动力，使用“标准”制造工厂进行当地生产是一项挑战，该项目旨在确定一种新颖和具有成本效益的方式，利用现有的和经过验证的技术，如模块化工厂和一次性技术，在LAMI国家当地生产IPV。这一办法将通过一个灵活的设施，减少对环境的影响，从而减少当地生产的资本成本，因为该设施对所产生的污染废物进行了更严格的控制。为了检验这一办法的可行性，需要为可行性研究提供资金。制造可行性分析将是本研究的第一步，将根据当前的IPV制造方法评估两种方案的成本效益。将选择一种方案进行进一步的市场研究，以揭示模块化生产的优势和劣势。因此，该可行性研究将是构建路线图的第一个组成部分，该路线图将导致替代制造解决方案，该解决方案与LAMI市场的需求更加相关，并具有实施和交付具有成本效益和更安全的IPV的长期愿景。

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.