Craig has 35 years’ experience in sales, marketing, product development, and project management in the industrial market, gained with major suppliers of PLCs, process control systems, power transmission equipment, and field devices. Craig’s focus areas include production management, OEE, HMI software, automation platforms, and embedded systems.
Craig Resnick, Vice President, Consulting, ARC Advisory Group
Innovative manufacturing approaches to assess pharmaceutical value and ROI are more important than ever for the life sciences industry. R&D innovation and the ability to scale up production processes quickly to minimize time to market and maximize competitive advantages is vital. Legacy systems and equipment are in need of updates and replacements with solutions that adhere to open communication standards to ensure interoperability and interconnectivity of all manufacturing assets to the rest of the enterprise.
The objective of manufacturers in the life sciences industry is to bring the benefits of digital transformation to all people, assets and processes involved in the manufacturing ecosystem. This means bringing the “smart” concept to plant assets & equipment, energy management, and continuous and batch processes, as well as to the plant operators and the asset & equipment suppliers and distributors. Innovation in manufacturing technology has never been more important and in greater demand than right now. Life sciences companies seek continuous process manufacturing solutions to improve product quality and reduce costs, as well as solutions for batch and single-use equipment in bio-technology based processes.
See how life sciences are using smart manufacturing solutions to improve manufacturing agility and optimize end-to-end drug manufacturing costs – read the ARC Advisory whitepaper to learn more
Life sciences manufacturers constantly seek to increase manufacturing operational agility and improve time to market – the challenge is to do so while lowering costs. To that end, greater focus on managing line performance is a viable strategy that can maximize return on existing investment. Life sciences manufacturers continue to increase use of modular production systems and disposable manufacturing, particularly for fast track products. Modularization provides the ability to quickly scale up the production of a new drug by creating multiple parallel production lines, allowing drug makers to ramp up production lines in numbers but not in size.
Investing in Technologies
Life sciences companies are investing in the technologies and infrastructure necessary to achieve and demonstrate compliance with current and future global regulatory requirements, such as the US FDA’s Continued Process Verification (CPV), 21CFR part 11 and data integrity. ARC sees increased activity in pharmacogenomics, the study of a person’s response to drug therapy, and the use of personalized medicine. Pharmacogenomics advances drive demand for individual medicines, and mass customization of personalized medicine results in more variations in product recipes. Increasing efficiencies, reducing costs and maintaining product quality will lead to an increase in automation expenditures.
The increasing complexity of life sciences manufacturing processes creates a growing demand for standardized applications for MES, batch, recipe management, and scheduling. Process and business visibility are becoming more significant, and integration to ERP, along with IT/OT convergence, is vital to operations. Advanced analytics need to be deployed as an integrated system component to reduce costs and improve productivity, in both the manufacturing process as well as how raw materials are managed. Predictive maintenance and analytics need to be used to help prevent unscheduled downtime, which is one of every manufacturers’ biggest issues. The industry needs better visibility and increased deployment of mobile devices for HMI, further leveraging wireless solutions, such as tablets and smart phones, where regulations allow.
To address industry trends, market drivers and challenges, it is expected the life sciences industry will see more smart manufacturing solutions that focus on key value propositions, such as improving manufacturing agility, optimizing end-to-end drug manufacturing costs, and digitalizing validation practices, compliance management and production operations. These smart manufacturing solutions will help the life sciences industry digitalize their operations, which will help these companies to reduce time-to-value, improve efficiency and asset utilization, and do so while ensuring product integrity, regulatory compliance and safety requirements are met.
To learn more about how Smart Manufacturing is transforming the life sciences industry, read the ARC whitepaper Smart Manufacturing in the Life Sciences and the article The Two Things You Need To Do Before Starting on a Serialization Journey, join the webinar “Increasing Profitability in Pharmaceutical Manufacturing” and explore Schneider Electric’s Life Sciences page.