Moderna’s launch of a COVID-19 vaccine and its approval for use in the United States, Canada and the European Union capped off what can only be described as a wild year. Behind the scenes, what unfolded was nothing short of a digital revolution in the biopharmaceutical industry. For other industries and the manufacturing sector in general, this success story is also a case study demonstrating the benefits of digital transformation.
Perhaps it shouldn’t be surprising that digital transformation makes sense for the pharmaceutical industry. After all, our genetic information is literally digitally transcribed in our DNA, with base pairs adenine-thymine (A-T) and cytosine-guanine (C-G) acting as zeros and ones. If you need a quick refresher on high school biology, check out this article.
Vaccines have been around for over a century, and traditional production methods have not changed much. As explained by the Centers for Disease Control and Prevention (CDC), influenza vaccines are most commonly produced by taking weakened viruses or vaccine viruses and injecting them into eggs or cell cultures to effectively farm them. The harvested viruses are then inactivated, purified and distributed as “flu shots”.
Not surprisingly, growing vaccines in this manner can be challenging, with so many variables at play. Issues can include in-lab virus mutations, difficulty growing viruses in eggs, and the long lead-time required to produce vaccines this way.
How does traditional vaccine production contrast with the development and production of Moderna’s vaccine? Here’s a quick timeline that illustrates the difference.
January 2020: China publishes the genetic sequence online for the novel coronavirus detected in late 2019. It’s worth noting that this digital version of the virus was shared long before any labs got a physical sample.
48 hours later: Moderna and the National Institutes of Health (NIH) design the full chemical structure of a vaccine based on the digital copy of the virus they have received, and conduct in silico testing (that is, computer simulated testing).
60 days later: First human testing of vaccine.
December 2020: Vaccine is approved for human use by the U.S. Food and Drug Administration (FDA).
In comparison, the first SARS vaccine took 20 months to go from the lab to human testing. What’s even more astonishing is that the COVID-19 vaccine modeled 48 hours after reviewing the digital transcription of the virus is exactly the same vaccine that is currently in distribution. Arguably, things could have moved even faster!
What’s even more interesting is how this particular technology works, and some of the implications for industrial manufacturing processes.
The Moderna COVID-19 vaccine is an mRNA medicine, consisting of sets of instructions for cells in the human body to manufacture proteins to attack the virus. The process for manufacturing the vaccine is quite different from traditional methods; instead of growing in cells or eggs, the vaccine is produced in large bioreactors that consist of enzymes and amino acids.
By transporting only the instructions for the human body to produce the required proteins, this type of vaccine also takes advantage of another digital manufacturing process—the one inside every cell.
What makes this truly fascinating is that, once validated, this production platform can be used to make vaccines for many diseases. While the digital instructions developed to match the digital fingerprint of the disease will differ, everything else will remain virtually the same.
The central theme of this story is digitization. Let’s review the main points:
While this is a story about the digital transformation of the traditionally analog pharmaceutical industry, it also raises important questions that resonate across the broader manufacturing sector.
What does this mean for your manufacturing operations? Let’s explore three key considerations:
Can you create a new product and send manufacturing instructions directly to the plant floor? Technologies such as additive manufacturing and computer assisted manufacturing (CAM) make this possible, but not all companies have invested in this capability.
Alternatively, is your production planning a seamless digital process? Do you have systems in place that will automatically take a sales order from the Enterprise Resource Planning (ERP) system and send it directly to the plant floor for hourly/daily/weekly/monthly scheduling? Does your ERP system interact with other digital systems on the plant floor to make this happen?
Keep in mind that any human involvement, whether it’s interpretation of information or manual entry of work orders, is open to errors. In effect, these manual interventions are the analog equivalent of growing things in chicken eggs.
It’s not enough just to be able to record data in a digital system. The whole point of going through the digitization process is to do things that can’t be done in the analog world.
You need to look to your digital systems for business insight. What is a better way to plan production? Do you anticipate seasonal changes in demand that you need to account for through changes in inventory? Is one of your SKUs low profit but critical to maintaining full capacity?
One key advantage of having digital representations of viruses is that biopharmaceutical companies can use computers to develop vaccines more rapidly and efficiently. The same advantage applies to digital business planning and production.
Perhaps most importantly, particularly given how dramatically companies needed to adapt to changing market conditions in 2020, is the ability to change production across SKUs and your product mix. One of the most important aspects of Moderna’s COVID-19 vaccine production is that they have built a platform that can develop vaccines for many new diseases on short notice.
Having a platform rather than a uniquely customized production line is the easiest way to adapt to changing market conditions. There are many ways that rapid shifts in production can be achieved (additive manufacturing and CAM have already been mentioned). At the core of this adaptability is an integrated digital system that can connect different hardware and automate the process of relaying commands and data that enable the rapid development and production of new products and SKUs.
At the same time, ensuring that you have the supply chain to support short-notice manufacturing will also be critical - the world isn't 100% digital (yet).
What has been achieved by vaccine-producing pharmaceutical companies in the past 12 months is revolutionary, and their accomplishments will have profound consequences for how we prepare for and respond to infectious disease in the future. For businesses in other industries, it’s worth studying closely, paying particular attention to how digital technology is interweaved in every step, including the end-product.
Biology is a realm that has traditionally been seen as among the most analog of sciences, but if it can be transformed into the digital realm, then there is no reason why traditional manufacturing practices cannot follow.
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