Today’s pharmaceutical industry faces many of the same goals it has faced in the past decades: To provide lifesaving & life-improving therapies to as many patients as possible while remaining financially healthy. Easy to say, difficult to do.
Now, leaders must fulfill the same goals with a new foundation: Meet global Net 0 commitment. Less easy to say, even more important to do.
Because of this, the pharmaceutical industry is held accountable for its sustainable products and operations. To meet this challenge, organizations need to consider the formulation complexity, product safety, quality and regulatory considerations that have been and will remain top of mind.
Responding to these considerations, digital and connected enterprise systems across the product lifecycle have made significant strides to expedite pharma’s ability to identify, operationalize and optimize sustainable drug and biologic discovery, creation, manufacturing and distribution.
In this article, we will address some of the top opportunities within the pharma industry that will not only improve organizational sustainability, but also the quality of products and processes.
Material Innovation Enabled by Digital Knowledge Management (DKM) and Product Lifecycle Management (PLM)
In the pharmaceutical industry, the quality of the product, its delivery mechanism and the creation process are all critical for patient safety and effectiveness. This responsibility is embraced by the industry, regulated by GxP compliance, and closely monitored by people, systems and business processes. In response to this responsibility, pharmaceutical development has been supported by DKM and PLM systems.
These enterprise systems follow a product from early ideation through the end of its lifecycle and have been built on the foundation of Quality by Design (QbD). QbD creates a framework that enables efficiency and optimization around the critical attributes of quality, material and process. It also ensures data integrity, all leading back to better quality products.
By providing a detailed view into the lifecycle stages of a product, pharma organizations can not only expect clear results in quality, but also achieve faster innovation, shorter time to market, greater product development data integrity and clear transparency within the supply chain.
These benefits pave the way for untapped potential to leverage the product and process design data being managed to target quality, sustainability, safety, effectiveness requirements and results, while remaining GxP compliant.
Deployed and emerging instances of PLM and DKM should be aligned with material and process innovation, sustainability strategy and KPIs in order to holistically approach sustainable product and process development.
OEE Optimization through Analytics and Machine Learning (ML)
Among the emerging technologies that offer sustainable outcomes for pharmaceutical manufacturers are soft sensors. These are virtual sensors that allow measurements to be contextually processed when applied and connected to IIoT applications. They can be attached to bioreactors, and many other assets on the manufacturing floor, enabling real-time data reporting and prediction and sensing when parameters, such as temperature, humidity, or any other variables fall out of both pre-determined quality and WAGES consumption parameters.
By predicting a wider variety of parameter excursions, machine operators and manufacturing floor management can systematically address WAGES waste, meet their OEE goals and make significant progress toward Net 0 operations.
Material Waste Reduction via Artificial Intelligence (AI) and Virtual Line Commissioning
Where Soft Sensors model and monitor sub-process sufficiently to provide insight into physical parameter performance, digital twin technology emulates a much larger scope. Using CAD, physics engines and biochemical models, the entire entity and process can be mirrored in a virtual environment. As a technology, it allows sites to:
Evaluate the availability and suitability of digital equipment geometric data
Reduce line commissioning times
Enable virtual line commissioning capabilities
Utilize process simulation models, reducing material waste and limiting the energy required to physically test assets
For pharmaceutical manufacturing, process & product validation are crucial steps in GxP compliance. During the COVID pandemic, the complexity of process and bio-product validation created major obstacles in scaling vaccine production or replicating complex processes in CDMO facilities. Proving again that “necessity is the mother of invention”, these mounting challenges have driven massive advances in Digital Technology Transfer. Manufacturers have begun to overcome this bottleneck by applying AI techniques for information extraction and leveraging the data already contained within quality and design frameworks.
A recent powerful use case for these technologies has been Continued Process Verification (CPV). Using statistical process control models and exhaustive scientific principles, processes and their critical parameters can be monitored in real time to identify potential batch failures before they occur and build in controls to bring parameters back into tolerance. This process reduces waste and improves compliance and traceability, while also identifying opportunities to improve product yields. Each of these solutions can be done individually or combined.
When applying digital twin to an entire production line, the emulation of a process can be housed in the virtual model, as can numerous soft sensor applications, just like an application running on a computer. Together, these give granular, real-time insights into WAGES consumptions, with the ability to simulate the cause-and-effect behaviors. The resulting “smart factory” gives incredible opportunities for data analysis, with the ability to address direct questions of utility usage across the facility.
IIoT-Enabled WAGES Optimization
The complex, process-intensive nature of pharmaceutical manufacturing makes it vulnerable to undiscovered or unaddressed optimization opportunities across five major natural resources: Water, Air, Gas, Electricity and Steam (WAGES).
These improvement opportunities range from harnessing electricity from renewables, reducing leaks throughout the steam sterilization process or simply reliably visualizing greenhouse gas emissions at a global, plant and asset level.
Over the last decade, the cost of non-renewable energy has significantly increased and shows no sign of slowing. For pharmaceutical manufacturers who have a large geographic footprint, deploy complex or energy-intensive machinery, or require precise environmental or temperature controls, focused WAGES optimization is not only critical for sustainability improvements but provides material cost savings.
Leaders in energy management and WAGES optimization projectsare quickly reaping results.
In a recent multi-campus deployment of Energy Optimization software, a major manufacturer reduced annual energy spend by $600,000, while simultaneously accelerating progress toward eliminating reliance on coal by 2025.
Another manufacturer, acknowledging the need to precisely cool product at critical junctures of the manufacturing process, deployed an AI-powered chilled water system. This enabled them to both more precisely control temperature and limit over-cooling that consumes unnecessary energy. They realized energy efficiency improvements of +10% as well as reduced their carbon emissions by 95,000 tons.
The mechanisms for measuring, reporting on, and optimizing all five components of WAGES, and the energy often generated by them, can and should be approached with a holistic technical infrastructure and strategy.
As pharmaceutical leaders are building that strategy, it’s important that they keep in mind that the myth manufacturers must sacrifice product quality in order to enable more sustainable practices has been thoroughly debunked. Pharmaceutical organizations that are embracing a sustainable future are deploying the digital solutions that will enable them to operate in the future.
There is a direct relationship between pharma’s digital and sustainability journeys. Digital solutions across the drug development process are a catalyst for systematically visualizing, measuring, reporting and optimizing the use of non-renewable materials and WAGES. These improvements will significantly improve regulatory compliance, financial standing, and global contribution to the healthy human experience.
Whether you’re already a global sustainability leader, or just starting out, it's time to think about your digitally-enabled sustainability journey.
Sachin lives in Austin, Texas with his wife Michelle and their 2 dogs. He enjoys cooking Indian and other Asian cuisines, enjoys golf, and is an active industrial designer for charity and open source. He is a technology enthusiast and builds various devices in his spare time utilizing existing and emerging technologies such as IoT, Arduino, Particle and additive/subtractive manufacturing. Some of his designs can be found at http://thingiverse.com/Sachin/designs
Erin is passionate about clients' opportunities to continuously improve through digital transformation. With the correct digital solution, agile and iterative project management approach, and Kalypso partners, any corporate goal can be achieved. Outside of Kalypso, you can find Erin hiking, camping, in the martial arts mat or ring, traveling to explore a new area, or finding the next book to read.
Though born in Paris, Peter was privileged to grow up in Guinea, West Africa. His friends on the continent taught him a profound love of story, laughter and a well-timed joke. Peter loves ethnic cuisine, a good book and working with his hands - be it woodworking or tinkering with his Raspberry Pi.