Towards continuous flow manufacturing of active pharmaceutical ingredients in Africa: a perspective

IF 3.4 3区 化学 Q2 CHEMISTRY, MULTIDISCIPLINARY Reaction Chemistry & Engineering Pub Date : 2024-07-30 DOI:10.1039/D4RE00299G
Sinazo Nqeketo and Cloudius R. Sagandira
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Abstract

Africa has a double burden of communicable and non-communicable diseases, accounting for 26% of the global disease burden. Pharmaceutical medicines are critical components in treating these diseases; however, only 3% of global drug production is carried out in Africa, which results in limited access to medicines. The local active pharmaceutical ingredient (API) manufacturing industry is not well established. Africa hugely depends on imports. Thus, the need to establish local API manufacturing capability is obvious. In this review, we highlight the efforts and hurdles in the local manufacturing of APIs and recommend sustainable ways to establish local continuous flow API manufacturing capability. Continuous flow manufacturing is an innovative and enabling technology platform that is increasingly impacting the pharmaceutical industry. Africa can leverage continuous flow technology to establish a state-of-the-art, sustainable, competitive local API manufacturing industry. Although this approach is noble, it is not without its challenges. Some of the current challenges for the full-scale implementation of continuous flow manufacturing in Africa include the lack of pilot scale or demonstration facilities to bridge the chasm between research and commercialization, inadequate funding, prohibitive infrastructure costs and scarcity of skilled local talents with knowledge and expertise in modern manufacturing techniques. This review also showcases all examples in which continuous flow technology has been successfully applied exclusively in API syntheses within the African continent. The grand vision is to contribute towards the transformation of Africa into an innovation-led, technology-based and knowledge-based continent through the adoption of cutting edge innovative and enabling technologies. This can transform the local pharmaceutical industry into a responsive industry that meets continental health security, social, economic and political needs according to the African Union's Agenda 2063, Sustainable Development Goal 3 (SDG3) and Universal Health Coverage (UHC) goals.

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在非洲实现活性药物成分的连续流生产:透视
非洲承受着传染性和非传染性疾病的双重负担,占全球疾病负担的 26%。药品是治疗这些疾病的重要组成部分,然而,非洲的药品生产量仅占全球的 3%,这导致非洲获得药品的机会有限。当地的活性药物成分(API)制造业尚未完善,非洲严重依赖进口。因此,建立本地原料药生产能力的必要性显而易见。在本综述中,我们将重点介绍在当地制造原料药方面所做的努力和遇到的障碍,并就建立当地连续流原料药制造能力的可持续方法提出建议。连续流生产是一个创新的技术平台,对制药业的影响与日俱增。非洲可以利用连续流技术建立最先进、可持续、有竞争力的本地原料药制造业。虽然这种方法很高尚,但也并非没有挑战。目前在非洲全面推行连续流生产技术所面临的一些挑战包括:缺乏中试规模或示范设施来弥合研究与商业化之间的鸿沟、资金不足、基础设施成本过高,以及缺乏掌握现代生产技术知识和专长的本地技能人才。为了更全面地了解情况,本综述还展示了仅在非洲大陆成功将连续流技术应用于原料药合成的所有实例。宏伟的愿景是通过采用尖端的创新技术和使能技术,将当地制药业转变为符合非洲联盟 2063 年议程、可持续发展目标 3(SDG3)和全民健康覆盖(UHC)目标的顺应性行业,从而为非洲转变为以创新为主导、以技术为基础、以知识为依托的大陆做出贡献。
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来源期刊
Reaction Chemistry & Engineering
Reaction Chemistry & Engineering Chemistry-Chemistry (miscellaneous)
CiteScore
6.60
自引率
7.70%
发文量
227
期刊介绍: Reaction Chemistry & Engineering is a new journal reporting cutting edge research into all aspects of making molecules for the benefit of fundamental research, applied processes and wider society. From fundamental, molecular-level chemistry to large scale chemical production, Reaction Chemistry & Engineering brings together communities of chemists and chemical engineers working to ensure the crucial role of reaction chemistry in today’s world.
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