Why Accessible, Worldwide Biomanufacturing Solutions are Paramount

Accessible, worldwide biomanufacturing solutions are imperative for various reasons including promoting health worldwide, prioritizing equitable access to treatments, and strengthening the resilience of health systems and economies. When we think about vaccine and drug development on a global scale, it’s important to note that it’s not a one-size-fits-all approach. Genetic and regional differences mean that vaccines and drugs must be tailored to effectively meet the unique requirements of various populations. True equity in biomanufacturing can be achieved but is multi-faceted, with social and technical considerations.

Accessibility starts with understanding why genetic differences in humans matter

Individuals with varying genetic backgrounds respond to drugs and vaccines in numerous ways. Genetic differences can influence how a person’s body metabolizes a drug, its effectiveness, and the likelihood of experiencing side effects. 

Historically, many clinical trials have been conducted predominantly on specific populations, often in males of Icelandic or Nordic descent, and this lack of diversity can lead to health disparities. Think of the nations in Africa, for example, the most genetically diverse continent on earth with the highest rates of pregnancy and HIV burden. These comorbidities can change the complexity of a patient’s clinical response to a health intervention. If certain population groups are not well-represented in clinical trials for a certain drug, imagine how many people will become ill from it if they don’t receive the right dosage.

This is a contributing factor to why precision medicine, for example, where effective and safe treatments are tailored to an individual’s genetic, experiential, and environmental makeup, has gained impactful momentum. Researchers can develop more precise treatments that are effective for smaller subsets of patients with specific profiles, creating targeted therapies that can improve healthcare outcomes.

The building blocks for achieving manufacturing sovereignty 

Manufacturing sovereignty occurs when a nation can independently produce goods, resources, or technologies, for example, without a significant reliance on global supply chains. This concept was further solidified during Covid-19, which highlighted supply chain vulnerabilities. Accessible worldwide biomanufacturing starts by meeting the needs and unique requirements of various patient populations, reducing barriers to market entry through low-cost initiatives. For example, in an area with low vaccine adherence, specifically mRNA-based vaccines, there’s a new effort to foster vaccine production and sovereignty in Africa, which will incentivize the use of technologies that support efficient, low-cost manufacturing, helping the continent prepare for future pandemics. Gavi, the Vaccine Alliance, has launched the African Vaccine Manufacturing Accelerator, a $1.2 billion financing mechanism to provide incentive payments to cover the increased costs of manufacturing. This highlights the growing role of government funding in supporting vaccine development — a much-needed and promising initiative.

Vaccine and drug development methods have evolved significantly in recent years. Legacy (or traditional) manufacturing, characterized by large, single-product, fixed facilities producing billions of vaccine doses at the lowest possible cost, often overlooks human diversity and can be slower in its technological adoption and adherence to other market disruptors. In contrast, small-footprint manufacturing offers cost-efficiency but with the flexibility to produce smaller batches. This is extremely important for resource-limited settings. In a time where efficiency and accuracy are prominent measures for success, small-batch manufacturing emerges as a cost-effective method for drug production. 

Continuous methods for protein manufacturing, such as perfusion, for example, have transformed protein production as raw materials are continuously fed into the system, creating products seamlessly. This mechanism reduces upfront capital investments, lowers operational costs, and enhances flexibility and productivity, among other things. Furthermore, perfusion fermentation requires less physical space, allowing for a smaller process footprint while still ensuring consistent product quality. This method also offers flexibility, making it easier to switch between products. Enhancing scalable production, perfusion fermentation is positioned as a key growth driver in the protein bioeconomy. 

How biomanufacturing solution providers can adapt to diverse needs and perspectives 

Learning starts with asking the right questions and being prepared to listen. For example, consider the Global South or low- and middle-income countries and how they interpret language. Think about manuals, for example. The words in a manual must be digestible and understandable, as word choice can impact an individual’s interpretation. It’s also important to think about the way people physically engage with equipment to ensure it’s accessible for people in that region, based on their physical makeup and associated capabilities and limitations. Additionally, we must think about things like price and how this topic is communicated within diverse environments. There are sensitivities surrounding cost, so it’s imperative to explain price structures in a way that doesn’t feel overwhelming. This starts with meeting people where they are, so key stakeholders, customers, and prospects understand a product’s value.

The biomanufacturing industry, like many within the healthcare landscape, continues to evolve in a promising way. There’s an increase in female representation, for example, where more female minds — including scientists, engineers, operators, and decision makers — are involved in the drug development process. In general, the industry is diversifying little by little and is also prioritizing total patient care in a more intentional and targeted way than ever before, with patient well-being at the forefront. 

Technological advancements in small-footprint manufacturing, layered with increased diversity, inclusivity, humility, and active listening within the industry, can present a more holistic view of the driving forces behind accessible global biomanufacturing. The convergence of technological innovation with a more human-centered approach is key to achieving a more equitable, flexible, and sustainable future for biomanufacturing worldwide.

Photo: gorodenkoff, Getty Images

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