To address operational challenges, pharmaceutical companies are undergoing a digital transformation that includes smart manufacturing and IT/OT convergence. These challenges, and benefits that can be obtained from the digital transformation and new robust and reliable infrastructure technologies, will be addressed in this brief.
Life science manufacturers are undergoing a digital transformation—making use of new, smarter technologies—that leads to operational excellence. Leading pharmaceutical and biotech companies must continue to adapt to increasing global pressures including new competition, increasing regulations, public healthcare pressures, personalized medicine, product quality, newer processing methods, and a new generation of technologies. Companies need to deal with traditional, complex and new modern manufacturing processes and technologies that can accelerate the flexible production of innovative medicines with the utmost consistency, efficacy and patient safety. It is important to mitigate challenges that could arise anywhere along the life science continuum, from the source of a product’s ingredients through the product’s manufacture, storage, transit, sale, and distribution. It is imperative for production operations to adapt to meet newer, more complex regulations. Companies must reduce production costs to meet competitive pressures, to compensate for pricing pressures, and to efficiently achieve regulatory compliance. Global and local regulatory requirements are necessary to ensure drug safety, traceability and end-to-end supply chain synergies. Other challenges include being agile and responsive to new market opportunities for personalized medicines. The need to embrace new technologies such as moving from batch to continuous process, implementing PAT technologies, and adopting single use disposables. New IIoT and smart technologies can address some of these challenges to improve processes and expand production.
Digital Transformation Goals
Objectives for this “global digital transformation” of manufacturing and the pharma industry include:
- Digital transformation for operational excellence
- Simplified, flexible and robust IT/OT infrastructure to reduce risks
- Simplicity & flexibility for new product production, faster time to market and innovation
- Reliable integration of information and disparate equipment silos to optimize production
- Improved data collection for regulatory documentation and compliance
- Global competitive pressures to reduce manufacturing costs and flexibility for scale-up
- Ensuring product quality, safety and efficacy
- Meeting the challenges of a complex supply chain
It is important for Manufacturers to be flexible and adapt to changing processes and differentiate by bringing more complex products to market quickly. This requires an infrastructure that is robust, flexible and harnesses the power of digital transformation.
Some of the Goals, Drivers, Challenges of the Digital Transformation in Pharma
Operational excellence is about increasing production efficiencies, continuous process improvements, maintaining or improving product quality, and reducing costs. Operational excellence is the key to sustainable revenue and business growth. It is about excellence in purchasing, production, distribution, logistics and inventory management. Manufacturers are integrating real-time information by using flexible technologies that can respond to changes in the market, enable faster decision-making, and optimize efficiencies to drive down costs. The digital transformation is an enabler for operational excellence, delivering improved platforms and connectivity. These improvements can empower organizations and people throughout the business to manage performance and align actions to improve business performance. It is critical that operations react to “on-the-fly” changes in the production environment. These include changes in raw materials, production, equipment availability, faster clean-in-place, product tracking, customer demand, shifting priorities, inventory shortages and capacity changes, labor shortages, and any number of unexpected events. Operations must know where everything is; what and how much is needed; and what, when, and where it is supposed to be produced.
Eliminate Information and Equipment Silos to Improve Visibility
To achieve the level of integration required, it is necessary for pharmaceutical and biotech manufacturers to have complete control of their manufacturing operations. To do this, pharmaceutical companies are connecting the enterprise digitally – removing silos by connecting all the data and information. Not only does this enable better regulatory documents, but it also enables pharmaceutical companies to meet the requirements for high-quality. Improved connectivity and process visibility can help reduce costs, prevent losses, improve revenues, and help organizations identify new, potentially profitable business opportunities.
IT/OT Convergence and the Connected Plant
Companies are investing in smart digital manufacturing technologies with connected technologies that support operational excellence and can be maintained by regular plant workers. Many of these technologies involve new platforms, new production and automation systems and a stable infrastructure. Operational excellence is an overriding vision for most manufacturers where they produce the highest quality product at the lowest possible cost. Leading manufacturers are flexible and can easily adapt to new products and production processes. This is where a simplified IT/OT infrastructure can enable the connection of the information and equipment silos that streamline and improve manufacturing processes and overall supply chain synergies. It is necessary to implement the easiest path to a robust OT/OT infrastructure that can address existing application needs and is also capable of rapidly scaling up to address future production requirements.
Strategies for the Digital Transformation
Manufacturers can take the following steps to successfully initiate their digital transformation:
- Insist on an infrastructure that properly supports a connected digital transformation, while ensuring the simplicity and flexibility needed to address the challenges of life sciences’ manufacturing
- Take advantage of standards that help reduce costs and ensure product integrity throughout the supply chain with the visibility and traceability required
- Utilize a flexible and robust IT/OT infrastructure that can address existing application needs and rapidly expand for future production requirements
- Enable reliable integration of information and equipment silos
- Ensure process visibility and reliability with the new platform
Stratus Technologies can help achieve the above objectives to optimize production, get to market faster, improve or maintain quality, safety and efficacy, ensure global regulatory requirements, and harmonize your supply chain.
Manufacturers must undergo a digital transformation to remain competitive and meet global manufacturing challenges. It is essential to integrate and connect a breadth of new manufacturing production and supply chain information technologies that can support operational excellence, global compliance, streamline manufacturing production changes, and help produce products with perfect quality and zero waste. To do this, the underlying IT infrastructure technology that the manufacturer ultimately chooses should align with their business strategies. Ultimately, manufacturers need to undergo a digital transformation with a robust IT/OT infrastructure that can improve the bottom line and increase value, improve production processes and reduce risks.
Optimizing production, and ultimately synchronizing the end-to-end supply chain, requires common global practices and a standards-based automation and infrastructure. The initiative should include collaboration, adequate documentation for global enforcement, and the implementation of appropriate emerging technologies. New production processes will require an infrastructure that is easy to implement, flexible and reduces costs. Although there is no magic bullet, the right partnerships and infrastructure technologies can help.
More info regarding this topic can be found in a joint ARC Advisory Group and Stratus Technologies webcast entitled: “Addressing the Future of Life Science Manufacturing Automation Challenges through Modernization”. Click here to view the recording.This paper was written by ARC Advisory Group on behalf of Stratus Technologies. The opinions and observations stated are those of ARC Advisory Group. For further information or to provide feedback on this paper, please contact the author at [email protected] ARC Briefs are published and copyrighted by ARC Advisory Group. The information is proprietary to ARC and no part of it may be reproduced without prior permission from ARC Advisory Group.