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Manufacture Facilities, Vaccines, Standards & Regulation

Manufacturing a Fairer Future

In a letter to Nature, two women working in life science organizations – one in South Africa and one in the US – made a brief but striking case for greater pharmaceutical production capabilities in low-and-middle-income (LMIC) countries. They highlighted new technologies that would support small-scale manufacturing units, arguing that Africa’s “leapfrog” over complex wired infrastructure to cellphone-based communications proves that LMIC countries need not mirror pathways to development once taken in the Global North.

To dig a little deeper, we spoke with the two women in question – Rachel Chikwamba (Group Executive, Advanced Chemistry and Life Sciences, Council for Scientific and Industrial Research) and Kerry Love (Founder and CEO, Sunflower Therapeutics PBC).

Why do we need manufacturing capacity in LMIC countries?
 

Rachel Chikwamba: Individual countries and regions need to have some control over production capacity for vaccines and biologics to guarantee security of supply for their populations. The COVID-19 pandemic exposed the reality; an inability to manufacture vaccines left Africa and many LMIC countries unable to rapidly implement vaccination campaigns to protect their populations.

My own continent, Africa, was left in a particularly vulnerable situation. Under normal circumstances, the African countries import 99 percent of the vaccines they consume. They have no ability to secure vaccines for their own populations outside of special arrangements in which LMICs receive vaccines from “primary producer” countries (but only after those wealthier countries have secured sufficient supplies for their own populations).

African countries also face uniquely African health challenges, such as Ebola and other zoonotic diseases, which suggests a need for specific capacity. The growing burden of chronic diseases (including diabetes and cancer), treatment trade deficits, and the absolute lack of popular access to life saving treatments all add impetus.

What’s holding LMICs back?
 

Kerry Love: Put simply, building conventional capacity for biomanufacturing demands substantial upfront investment and physical space. These facilities then also require significant knowledge and experience to operate reliably. The availability of capital and trained workforces is a significant barrier. 

RC: In LMICs, there is often a lack of what one might refer to as the “absorptive capacity” to localize the manufacture of biologics, including infrastructure and resources across R&D, various relevant skills (for example, scientific, process development, techno-economic), and suitable regulatory frameworks. On top of this, the fragmented markets of LMICs can make it challenging for would-be manufacturers to take advantage of otherwise large market sizes – and when this challenge cannot be met, it becomes hard to justify investments in the necessary manufacturing capacity. 

Can technology help?
 

KL: Small footprint manufacturing technologies can lower the barriers to entry for diverse future market participants. For example, technologies that are smaller, fully-integrated, and automated are cheaper to install, require less resources to sustain, and can enable costs of goods that are competitive with  enough facilities that rely on economies of scale. Further, some of these technologies can flexibly produce a range of different products. This adaptability could provide market participants with opportunities to pivot to production capabilities based on shifting market needs or to advance new products for their regions.

As LMICs build domestic pharmaceutical capacity, what role will the brain drain often experienced in LMICs play?
 

RC: Skills development and retention are key to the successful establishment of domestic manufacturing. Our approach has been to establish open access translational research and scale up facilities for multiple technologies where entrepreneurs and scientists can access infrastructure, equipment, and skills to turn research outputs and concepts into prototypes for clinical development. We are also partnering with local and international funders to provide post-undergraduate training across the value chain, including technical training in product and process development, under current GMP.

The trick is to train significantly large numbers so that there is redundancy in the system, but also to establish actual production facilities to provide gainful involvement in manufacturing enterprises post-training.

KL: A parallel strategy is also possible by deploying technologies designed for diversity in operator backgrounds and perspectives. Integrated and automated manufacturing solutions with simplified user interfaces could expand the opportunities for new kinds of operators to engage and contribute to production. This approach would encourage a broader regional talent to help create new products where they are. In the end, Rachel is right; workforce training is and will continue to be a key ingredient for operational success in biomanufacturing. But I would add that enabling the broadest workforce possible will likely ensure the best outcome.

What lessons can be learned from higher-income countries?
 

RC: I would name three. First, huge investment into capital-intensive single product manufacturing infrastructure that takes many years to pay off may not be prudent, given the dynamism of global markets. In short, things can change quickly.

Second, drug accessibility must also be encouraged through improvements to regional or national healthcare systems – local manufacturing capacity isn’t the only key criterion.

Third, lowering barriers to entry for new technologies in mainstream markets may increase competition, ultimately improving accessibility.

How will quality standards and regulatory requirements have to change, if at all?
 

KL: Quality standards for biologic medicines shouldn’t change based on where they are made – patients everywhere should have access to high-quality treatments. However, strengthening regional regulatory capabilities will be crucial to enabling the efficient clinical development and commercialization of LMICs’ products. Regulatory awareness of new technologies and approaches, such as small-footprint systems and continuous manufacturing of drugs, also would be helpful.

RC: Challenging regional regulatory systems through the presentation of multiple technologies and multiple products for approval would likely work best – though we must do this without overwhelming the developing system. Additionally, regional harmonization of regulatory policy frameworks would help common markets develop, resulting in a more efficient means for distributing new products to the highest possible number of patients.

Are you optimistic about LMICs' future relationship with pharmaceutical manufacturing?
 

RC: Very much so – but optimism must be combined with action; therefore, we all must play our part. We need strategic partnerships along the value chain of pharmaceutical production and we need to champion our mission of increasing the absorptive capacities of our regions.

In LMICs, governments are the largest buyers of pharmaceutical products for the bulk of the population. Convincing local governments to provide uptake guarantees for certain critical products is essential. We need them to not only buy products from the cheapest manufacturers, but also allow and provide guaranteed markets for local emerging areas to facilitate the establishment and maturation of strategic manufacturing capabilities.

KL: I agree. Since the start of the pandemic, I have spoken to many different stakeholders worldwide who recognize how important it is to build biomanufacturing capacity in LMICs. There is significant momentum for this new approach and I am also optimistic!

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About the Author
Angus Stewart

Associate Editor of The Medicine Maker

Between studying for my English undergrad and Publishing master's degrees I was out in Shanghai, teaching, learning, and getting extremely lost. Now I'm expanding my mind down a rather different rabbit hole: the pharmaceutical industry. Outside of this job I read mountains of fiction and philosophy, and I must say, it's very hard to tell who's sharper: the literati, or the medicine makers.

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