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Developing an effective vaccine for COVID-19 is that rare thing, a shared worldwide priority. Leaving aside the various scientific and regulatory challenges that must be overcome, one of the toughest problems will be producing enough of a product that almost everyone on the planet will want. With over a hundred candidates in development, and a few human trials already underway, the question is: how can we produce enough for everyone?
Looking at the problem as a unique design and engineering challenge, we believe that there are three key factors that should shape the pharmaceutical industry’s thinking at this critical early stage. These are the importance of adapting existing facilities; the resilience of logistics and supply chains; and ensuring manufacturing choices work for everyone, whether they live in the advanced or developing worlds.
Don’t build, adapt
The concept of a vaccine might be simple, but the field comprises a wider variety of techniques and technologies than ever before. This variety of medical approaches unfortunately means planning production and manufacture becomes more complicated. Whichever vaccine gains approval, flexibility in productive capacity will be vital.
For major pharmaceutical companies, the adaptation of existing facilities and production lines is clearly going to save time and money over undertaking new builds, hopefully also simplifying planning and approvals processes. We know that there is plenty of manufacturing space available across the industry, owned by the right operators, but it will need to be adapted to meet the precise demands of the successful vaccine. Relevant permitting will be needed, to comply with each different regulatory geography.
Vaccine production must be safe, and with COVID-19's high transmissibility rate, containment would be a major issue. The pathogen safety level of the virus is at the midpoint between flu and Ebola, meaning repurposed facilities that developed flu vaccines would need significant upgrades.
Quality control and transparent record keeping are going to be another major challenge. Newly adapted facilities will need a digital audit infrastructure that ensures continuity and quality of the product produced and delivered. Vaccines demand highly controlled environments for production and storage, typically between 2°C and 8°C. Given vaccines will need to be produced worldwide, facilities in warmer climates will require more robust design to account for this issue. Digital systems for verifying and validating temperature performance in cold room are now possible using Internet of Things sensors and supporting software, but systems will need to be planned and designed early on.
Can your supply chain deliver?
Beyond the design of the vaccine’s production, there’s the problem of scale. The pharmaceutical industry normally produces vaccines to meet demand for a certain percentage of the population, not everyone. How will producers achieve supply chain resilience when the whole world will be chasing the same skills, suppliers, resources and materials at the same time?
Questions of supply chain management are always about how many elements interlock, and this challenge is no different. To succeed, and stay successful, producers will need to examine every upstream and downstream factor in the vaccine’s supply chain, from raw materials to energy supply to packaging, storage, security and fulfilment. It’s a case of designing in the resilience now, by exploring these factors and assessing risk. Our own ‘health check’ diagnostic tool can reveal weaknesses and provide an aerial view of the whole chain: including service partners to major producers. Risk analysis must be rigorous and ongoing.
Given the likely level of government investment, there may be interest in partnerships between traditional industry competitors, to help overcome bottlenecks or weaknesses in the supply chains that form. It might be time to have those conversations now.
A vaccine for everyone
Coronavirus has become one of the most dangerous viruses humanity has recently confronted, spreading rapidly in our highly interconnected world. Given that the whole world shares this common threat, at the same time, it’s important that the vaccine we produce should also work for everyone.
For designers and engineers, that means arriving at vaccine production solutions that can work as effectively in poor countries as wealthy ones. It means supply chains that don’t simply serve the most advanced societies. It means a safe and effective product, whose manufacture is based on resilient and environmentally sound use of energy and materials. This is a great opportunity to bring every built environment innovation we have developed to bear, on what will be one of the largest manufacturing efforts in human history.
