As medicines have evolved over the past few centuries, so have the methods employed in their manufacture, from small-scale manual processing to the large-scale, automated manufacturing practices of today. Indeed, the pharmaceutical sector is now a trillion-dollar globalized industry, producing billions of doses per year to meet the demands of a healthy population.
Smart manufacturing is revolutionizing the production of pharmaceuticals in the modern economy, leveraging advanced and innovative emerging technologies to provide significant benefits for the modern pharma industry and human health. This article will look at this subject.
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Introduction to Smart Manufacturing in Pharma
Smart manufacturing is the integration of multiple digital technologies, such as automation, the Internet of Things (IoT,) and data analytics in the manufacturing process. Essentially, it is an information and event-driven orchestration of digital, physical, and business processes across the entire value chain. People and machines work in synergy with each other in the smart manufacturing process.1
Pharmaceutical manufacturing is an extremely important industrial sector, producing drugs, vaccines, and therapeutics for a myriad of human diseases and medical conditions. As such, it has become increasingly regulated over the past few decades to ensure that safe and efficacious end products are released onto the market for consumption by patients.
Additionally, the pharma industry is facing increased demands for efficiency and precision in its manufacturing processes. To ensure the sector produces high-quality products and meets regulatory compliance as well as satisfying precision and efficiency demands, pharma companies have increasingly embraced innovative and emerging technologies over the past few decades.
Technologies such as AI, IoT, data analytics, automation, and robotics have begun to challenge the traditional manufacturing paradigm. Smart manufacturing can help to revolutionize the entire process of producing pharmaceuticals, helping the industry satisfy the demands of modern medicine.2
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Key Smart Manufacturing Technologies
Smart manufacturing encompasses a raft of digital technologies to ensure efficient and precise manufacturing processes. It has proven to be revolutionary for multiple industries and has been described by some as “game-changing.”
Smart manufacturing combines IT and industrial automation, integrating physical manufacturing equipment with technologies such as sensors, which, when used in conjunction with software, help to improve performance by providing better predictive abilities and control of processes. In essence, a self-regulating system is made possible by combining these technologies.
Key technologies employed in smart manufacturing include robots, automation, big data analytics, AI, machine learning, and cloud computing. A significant facet of smart manufacturing is IIoT (Industrial Internet of Things) technology, which connects devices and systems, helping to capture vital data that can be used to improve productivity and operational efficiency vastly.3
Automation and robotics help to automate repetitive tasks, reduce human error, and speed up production timelines. Robots can work 24 hours a day in smart factories. Data analytics and AI help to optimize production processes, improve predictive maintenance, and improve quality control.
Real-time monitoring and IoT technologies monitor equipment, track data, and provide real-time feedback, reducing waste and improving accuracy.
Smart Manufacturing for Pharmaceuticals
Benefits of Smart Manufacturing for Pharmaceutical Production
Smart manufacturing has some specific benefits for the pharmaceutical industry. These include cost savings, increased efficiency, and enhanced quality control.
By reducing human error, automated processes in a smart manufacturing workflow help to minimize the risks associated with faulty medicines. Minimizing waste, optimizing production lines, and improving resource management help to reduce costs in an industry with historically tight profit margins. Automating workflows and reducing bottlenecks leads to greater efficiency (as well as cost reductions.)
Furthermore, AI-driven analytics and real-time monitoring capabilities ensure consistent product quality and compliance with regulatory requirements.
Examples of Smart Manufacturing in Pharmaceuticals
Companies such as Pfizer and Glaxo SmithKline, giants of the pharma industry, have already reported the successful implementation of continuous manufacturing processes, one of the cornerstones of smart manufacturing. Regulators have approved a growing number of drugs produced using continuous manufacturing in the US.4
One case study published by Cognizant in 2020 highlighted the benefits smart manufacturing could bring to pharma companies.
A Fortune 50 pharma company needed to streamline its processes and systems after an acquisition, replacing legacy applications with a more efficient and unified manufacturing system. Cognizant provided multiple accelerator tools as well as the OnePlantTM framework to save over 4,000 person hours in the company’s operations, providing significant cost savings and accelerated ROI within six months.5
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Challenges in Implementing Smart Manufacturing
However, despite some notable examples of companies leveraging the benefits of smart manufacturing, as mentioned above, there are still some key challenges that hold back this potentially game-changing manufacturing process from achieving its full potential in the pharma industry.
Firstly, although a fully integrated smart manufacturing environment can make regulatory compliance easier, the transition requires new technologies and processes that must comply with existing regulatory conditions. This can be time-consuming and costly for pharma companies.
Secondly, many pharma companies operate legacy systems. Integrating smart manufacturing processes can cause downtime, which can lead to cost overruns and delayed product release.
Additionally, a lack of expertise in areas such as data analytics and automation can be highly challenging for companies making the transition to smart manufacturing. Other challenges include a lack of industry maturity, cybersecurity issues, and the complexity of the pharmaceutical supply chain.6
The Future of Smart Manufacturing in Pharmaceutical Production
The future of the pharmaceutical industry will be determined by the adoption of increasingly sophisticated and innovative technologies, cost considerations, and the evolving regulatory landscape.
Integrated, smart technologies such as smart manufacturing will likely play a key part in the evolution of the pharmaceutical industry in the coming decades as companies look toward the future of the industry and a changing world.
Fully automated, AI-driven factories could transform the drug manufacturing process, providing greater flexibility, efficiency, and scalability.
One emerging technology that could prove revolutionary in smart manufacturing for the pharma industry is blockchain. This technology, more widely associated with the world of cryptocurrencies, provides pharma manufacturers with enhanced product traceability and end-to-end verification across the entire production and supply chain.7
In Summary
Smart manufacturing is a broad scientific field that incorporates many emerging technologies, such as big data analytics, AI, automation, robotics, smart sensors, predictive analytics, and machine learning.
It could revolutionize the pharma industry by significantly improving cost-effectiveness, efficiency, regulatory compliance, supply chain traceability, and reducing human error, amongst a raft of benefits.
Many companies in the pharma sector that have traditionally relied on legacy systems and processes for the manufacture of pharmaceutical products are now embracing smart manufacturing, with some further along in the technological pipeline than others. Whilst highly challenging to implement, the benefits of smart manufacturing processes vastly outweigh any potential drawbacks.
References
- CESMII (2023) What is Smart Manufacturing? [online] Available at: https://www.cesmii.org/about/what-is-smart-manufacturing/ (Accessed on 10 October 2024)
- Arden, N.S et al. (2021) Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future International Journal of Pharmaceutics 602, 120554 [online] ScienceDirect. Available at: https://doi.org/10.1016/j.ijpharm.2021.120554 (Accessed on 10 October 2024)
- Neuron Team (2023) The Smart Manufacturing Revolution: Examples, Tech & Tips [online] emqx.com. Available at: https://www.emqx.com/en/blog/the-smart-manufacturing-revolution (Accessed on 10 October 2024)
- Piervincenzi, R (2022) Pharmaceutical continuous manufacturing: What drug makers need to know [online] Quality Matters. Available at: https://qualitymatters.usp.org/pharmaceutical-continuous-manufacturing-what-drug-makers-need-know (Accessed on 10 October 2024)
- Cognizant (2020) Pharmaceutical company’s smart manufacturing transformation [online] Available at: https://www.cognizant.com/en_us/case-studies/documents/smart-factory-transformation-for-pharma-codex2963.pdf (Accessed on 10 October 2024)
- Strimbu, J (2024) Smart manufacturing in pharma: from overcoming barriers to achieving operational efficiency [online] Siemens. Available at: https://blog.siemens.com/2024/03/smart-manufacturing-in-pharma-from-overcoming-barriers-to-achieving-operational-efficiency/ (Accessed on 10 October 2024)
- Leal, F et al. (2021) Smart Pharmaceutical Manufacturing: Ensuring End-to-End Traceability and Data Integrity in Medicine Production Big Data Research 24, 100172 [online] Elsevier. Available at: https://doi.org/10.1016/j.bdr.2020.100172 (Accessed on 10 October 2024)
Further Reading
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