The Road to Digital Connectivity

The COVID-19 pandemic helped highlight the best of pharma. The collaboration between business, regulators, academia, and governments was key to accelerating vaccine development and delivery. Now as the pandemic begins to subside, the industry can’t let go of its altruism, particularly as we continue to further integrate Industry 4.0 concepts into manufacturing practices. Future collaborations must include data and supply chains to ensure success.

To create a digitally-driven industry, we must also adopt a new attitude. Industry-wide connectivity can only be a reality when pharma acknowledges that it lags behind other industries when it comes to the uptake of digitized systems. The way we produce tablets has scarcely changed in the last 40 years; if we want to continue to innovate in pharmaceutical manufacturing, we must embrace newer, digitally-focused ways of thinking. Our facilities could become more efficient, productive, and sustainable – helping to allay costs, ensuring medicines to patients quicker, and lowering industry’s carbon footprint to help it reach net zero – if companies began to make the changes necessary to introduce digital systems capable of streamlining production.

Although the resulting monetary and reputational benefits will be attractive for companies, it really comes down to people. Increased digitization will enable better treatments and futures for patients. They can also free up capital for companies to re-invest, innovate, and benefit their workforces. This approach to workforce management undoubtedly makes for happier people who want to embrace the impending digital era where they collaborate synergistically with connected systems.

To highlight one example of the benefits of digitized systems, at the Medicines Manufacturing Innovation Centre, we’re working to supply drugs to patients ‘Just in Time’ in clinical trials through the development of an automated supply chain platform that can fill capsules and tablets with custom amounts of drug compounds and enable the production, packaging and labelling of multiple drugs in the same facility without cross-contamination. This mitigates the necessary drug overproduction that currently arises due to difficulties in predicting patient demand. 

The project amalgamates datasets using lean six sigma philosophies (an approach that really relies on collaboration to improve performance, processes, and quality). It connects data to further improve compliance, productivity, and efficiency by significantly cutting the time, resources, and cost associated with ‘Just in Case’ manufacturing approaches.

Let’s imagine this factory as a car. We’ve improved the operational technologies; upgrading the petrol gauge from an analog dial to a digital system, enabling us to see how much petrol is left in the tank to exact miles; and we’ve upgraded our GPS system from one that is). uploaded using a disc to one that updates in real-time via satellite, providing us with traffic updates. 

When we connect these two datasets, our car can now tell us when petrol is about to run out. But we do not need to worry, as the nearest petrol station has already been identified; our GPS can re-route to include a stop where we can fill up with fuel. These connected datasets have boosted our time efficiency, increased productivity, and improved compliance as we’ve not broken down and had to leave our car in the middle of a busy road. 

This level of integration will also be used to develop a real-time Qualified Persons (QP) dashboard, automatically gathering and connecting all data required for a QP certification decision to be made in one convenient place. This dashboard, which will pull critical GMP and registration data from the Medicines Manufacturing Innovation Centre and sponsor systems, will enable Just in Time QP certification at the same time as the product is packed. This will drastically cut the lead time between a clinical trial site ordering and receiving new medicine supplies as products can be rapidly released and distributed, This dashboard will also benefit regulators who currently inspect periodically throughout the year in-person, which poses resource challenges as production must cease as workers prepare for the inspection. Data is manually extracted and primed to be provided to inspectors, who assess production retrospectively. If instead, data were continually monitored through digital systems, regulators could make assessments remotely in real-time, eliminating the need for mass manual data extraction and preparation, or for production to be paused.

Digital twinning can also be applied to a continuous direct compression platform, as is being explored through another of the Medicines Manufacturing Innovation Centre’s Grand Challenges. This duplicates the medicines manufacturing process in a digital space, and uses a continuous workflow, helping scientists better understand their process design and equipment selection, and enabling the pharma industry to reduce its reliance on wasteful and inefficient large batch manufacturing.

In my view, the benefits of such connectivity are obvious. If companies are willing to apply it then we will see rapid and significant improvements in process efficiency.