The COVID-19 pandemic has changed our lives and our industry, not to mention our approach to operations. And, although people around the globe are beginning to see mask wearing and social distancing as the “norm,” we are experiencing exactly the opposite of normal. We are racing to fast-track a viable treatment and we don’t have a choice but to adopt digital transformation in order to achieve something that has never been done before: launching an emergency vaccine in just one year.
To make this happen, dozens, if not hundreds, of behind-the-scenes technologies and services will be critical to help connect the dots and push the development process forward at rapid speed from end to end. Digital transformation, often taken for granted, is playing a hugely important role to help global pharmaceutical companies move a vaccine from research and development to clinical trial to manufacturing to patient delivery. Digital transformation technologies will turn the typically serial process of a drug’s life cycle into compacted parallel processes leveraging digital automation, turning years into months and months into days.
Changing formulations quickly
This research and development process is time-consuming, and each new attempt requires deliberate and detailed work. In addition, because of COVID-19’s accelerated spread and time frame, there is added pressure to be precise. Digital automation is absolutely key in safeguarding and improving the development process.
This requires simplified technology transfer and overall information management. By providing common building blocks in each development stage, process automation enables the translation and transfer of recipes, process steps, critical quality attributes and critical process parameters across the vaccine’s life cycle.
Once the building blocks are in place, connecting them across the development stages requires a process and knowledge management solution that supports everything from the initial recipe structure and associated material and equipment parameters to its automated integration into the individual site automation systems, as well as the necessary change management tools to ensure appropriate version controls as the data and recipe evolves.
Rapid production and increased capacity
Manufacturing the new COVID-19 vaccine will also prove to be an element that requires speed and agility, and many vaccine developers are working with contract manufacturer organizations (CMO) months in advance of the vaccine’s approval.
This makes digital twin technology a vital component of the manufacturing process. For example, a digital twin can help connect experts to design, build and test strategies; virtually train operators for abnormal situations; and develop and test process improvements offline. Real-time modeling software can also provide optimized scheduling to determine the facility’s optimum capacity and automate scheduling to meet that capacity. In addition, cloud engineering will help compress capital project schedules and enable 24/7 engineering work to be globally distributed and remote tested.
All of this can happen while the approval process is taking place, ensuring production can begin immediately after approval.
Ultimately, by optimizing and having visibility into processes at both the corporate and the site level, pharma companies can better leverage their entire supply chain to increase total production volumes.
No room for failure
Delivering the vaccine to those millions or billions of patients is no easy task. And with such a condensed product development timeline, there is little to no room for failure. That makes achieving quality and compliance approval vital.
After the vaccine is approved, efficient production is essential to reduce batch variability, ensure quality and “right-first-time” production, and perfectly replicate subsequent batches. Releasing the vaccine in real time will require review-by-exception and automated release strategies that ensure everything was manufactured correctly and any deviations were addressed before releasing products.
In addition to improving the release process, ensuring facility operational integrity is a key part of optimized manufacturing. Real-time scheduling and predictive maintenance help ensure facilities are running reliably, at optimum capacity and are ready to support the entire supply chain. A leading biologics manufacturer saved nearly $6 million annually by increasing production and saving 10 days of lost production at one site. Using an integrated approach to automation and real-time scheduling and modeling, it was able to optimize production capacity and uptime, essential KPIs for any company trying to produce larger quantities of COVID-19 therapies.
Once the vaccine is finally released, it must be put into its final pill or liquid form, finished and packaged with absolute consistency. Automated solutions can help optimize equipment and material control processes at every phase of this critical process.
Production is critical but is not the final piece of this process. Last, but certainly not least, the vaccines have to be delivered safely to the hospitals and doctors that will use them. Cold chain tracking is the answer to this important component as it helps customers know the materials being shipped around the world are being properly maintained. From compressors, electronics and controls, to monitoring solutions and cargo tracking, automation provides holistic management of cold chain operations by reducing the complexities that can challenge operations.
Digital transformation as the enabler
This is all made possible by digitally transforming a company’s manufacturing operations management approach. This transformation is done by looking across the full scope of a site’s digital plant maturity model and determining what the appropriate solution options are. These solutions may include everything from adding new digital quality measurements in-line, modular/flexible automation on equipment skids, manufacturing execution and batch record systems, digital predictive maintenance applications, and electronic technology transfer systems. Ultimately, an integrated digital transformation solution enables manufacturers to go from production to release with confidence that they have met safety and quality requirements. All of this helps with FDA reviews and removes manual steps that add risk and delay release.
Considering the extensive end-to-end process to develop a vaccine, 12 months may seem like a daunting deadline, especially because it’s never been done before. However, circumstances are compelling enough to encourage record-breaking progress, and leaders in science, technology and government are collaborating to safely break through barriers.
Ultimately, as we aim to break out of the conventional process to fast-track COVID-19 vaccines, digital transformation technologies will be a key enabler to connect the dots and push the process forward at rapid speed. With any luck, this out-of-the-norm approach to developing and releasing a safe vaccine will happen faster than ever before — then we can get back to normal in record time. And in several years, today’s record-breaking digitalized manufacturing will have become the norm for delivering life-saving therapies to patients.