By Trevor Marshall, Director of Enterprise System Integration, Zenith Technologies03.01.18
The need for process optimization, regulatory compliance, and improvements in the supply chain are driving investment in automation technologies across the pharmaceutical industry. Consequently, the systems used to automate process steps during the manufacture of pharmaceuticals are continuously evolving with new instrumentation and control products coming to market.
This article will consider trends that impact the future of automation and what will likely be the biggest influences in transforming the pharmaceutical manufacturing environment.
Multi-Product Manufacturing Facilities
Gone are the days when manufacturing facilities could rely on developing the same product year after year. More targeted therapies that need to be manufactured in smaller volumes for smaller populations means the industry is seeing a transition away from “one-line-one-product” setups in favor of multi-product manufacturing facilities. These sites must be designed to be more agile, with the capability to react to changing demands quickly. The growing trend toward contract manufacturing is also driving the need for more flexible facilities to meet the needs of multiple customers.
Flexibility is key, and modern facilities need to be able to re-orientate their processes according to the requirements of individual products. As a result, sites are now being designed in a way that ensures a high degree of segregation between process steps, provides cross contamination control, and limits product exposure to the environment.
Single-Use Technologies
Aligned with today’s growing pipeline of high potency and biological drugs, the adoption of single-use technologies, such as single-use bioreactors and other unit operations, is having a significant impact on the way that automation is delivered. The integration of process control systems and manufacturing execution system (MES) solutions with start-to-finish technologies and single-use manufacturing platforms is helping the industry to deploy biopharmaceutical manufacturing with increased productivity and efficiency, and at a lower cost, which can significantly reduce the time-to-market for new products.
Both upstream and downstream manufacturing processes benefit from single-use systems. They reduce or eliminate the time required to perform cleaning and steaming, and they allow manufacturers to switch quickly from one product to another, or from batch to batch.
Single-use components are also an enabling technology for smaller scale production of biopharmaceuticals, including antibodies, proteins, vaccines, and cell therapies, which would otherwise be much more difficult to produce. In addition, as the world of gene therapy continues to evolve, the industry can expect to see even greater reliance on single-use technologies. However, as a starting point, many companies may in the first instance choose to pursue hybrid facilities with both stainless steel and single-use components.
Continuous Manufacturing
Batch manufacturing processes have a pre-defined maximum asset utilization on the plant floor. Traditional pharmaceutical companies have in the past been slow to investigate new manufacturing techniques, preferring a more risk-adverse approach to modifying the validated batch manufacturing design.
Cost pressures and the need to find ways to increase productivity have led to the introduction of new continuous manufacturing techniques across a number of unit operations in the life science industry. Oral solid dose tableting lines, continuous API production, and continuous chromatography in biological processes are but a few examples of where continuous manufacturing provides greater productivity for companies. With this also comes new challenges from an automation perspective, not only in the continuous manufacturing process but also in the batch record and genealogy requirements for the product.
Industry 4.0
Industry 4.0 is becoming increasingly important to the continued success and competitiveness of pharmaceutical manufacturers. It refers to new tools and processes that are enabling smart, decentralized production, with intelligent factories, integrated IT systems, the Internet of Things (IoT), and flexible, highly integrated manufacturing systems. For the life science manufacturing industry, it’s not about being new—it’s about using proven solutions and approaches to decision making to improve quality, reliability, and reducing waste. Companies in the life science industry have been collecting and using evidentiary data to improve their manufacturing processes for nearly 40 years and have some of the best quality systems in the world.
Industry 4.0 is simply the latest wave of technological advances that will drive the next phase of pharmaceutical manufacturing. It will enable manufacturers to have full visibility of operations and allow them to be responsive to information, while bringing connectivity of equipment, people, processes, services, and supply chains. Industry 4.0 will take automation to a new level with individual management processes expected to become automated. For example, if a temperature gauge makes a higher than expected reading, the machine will detect this and rectify the situation rather than requiring an operator to intervene and make an assessment about the required course of action.
In addition, future developments may mean that machine learning algorithms will be able to adjust manufacturing lines and production scheduling quickly. New developments will also pave the way for predictive maintenance and the opportunity to identify and correct issues before they happen.
The food and drinks industry is leading the charge in implementing Industry 4.0, with some companies in the sector beginning to use artificial intelligence to improve processes. Similarly, the automotive industry is also making considerable progress in terms of smart devices, the IoT, and achieving connectivity between all systems within a manufacturing plant.
Due to regulatory constraints, the pharmaceutical industry has been slower to adopt this type of cutting-edge technology. While embracing the potential for Industry 4.0 is going to be critical to future operational efficiency for all manufacturers, it may be a long time before the industry is able to complete the digital transformation and have fully automated and connected facilities that can take advantage of all the age of digital manufacturing has to offer.
Leveraging Data & Analytics
While the idealistic end game of fully connected, self-optimizing production processes may be further down the road, the first steps to digital manufacturing are well under way. Automation and technology create the opportunity to leverage data and analytics to improve processes. Often referred to as enterprise Manufacturing Intelligence (MI), access to more meaningful data means a better view of operations, allowing for better analytics and real-time responsive decision-making to drive continuous improvement and operational excellence.
With Industry 4.0 comes the introduction of edge devices; computing to make it easier to connect machines and the ability to create organization-wide data lakes. These edge devices can also be used to run analytics in real time close to the equipment while big data is analyzed in the cloud.
Big data also allows for the creation of digital twins. A digital twin can be made up of end-to-end data in the manufacture of a product where a fleet’s data can be used to find insights. Extension of the traditional “golden batch,” where data was very much process control-based, will be supplemented and surrounded with environmental data, raw material data, training data, and any other digital data available that goes toward influencing the golden batch. With this digital information available across multiple sites, batches and suppliers, sophisticated advanced analytics can provide a digital twin that best represents the golden batch and alert controllers to any problems based on these specific data sets.
Final Thoughts
Automation and other manufacturing systems, such as MES, have the potential to transform processes within pharmaceutical manufacturing facilities, opening the door to fundamental performance improvements. For manufacturers that fail to leverage these technologies, the introduction of new pharmaceutical products may take months or years rather than weeks, and they will likely find themselves falling behind their competitors in the efficiency stakes. Companies that take the initiative early stand to gain the biggest competitive advantage, ensuring they can operate with greater agility, cost-efficiency and compliance.
Author the author: Trevor Marshall is director of enterprise system integration at Zenith Technologies and has worked for over 20 years in the pharmaceutical and biopharmaceutical industry. Working as a Business Unit lead for Zenith Technologies he oversees the delivery of projects globally for the company. He also leads the consulting business, advising clients on best practices for implementation of manufacturing systems encompassing DCS, MES, and Historian systems.
This article will consider trends that impact the future of automation and what will likely be the biggest influences in transforming the pharmaceutical manufacturing environment.
Multi-Product Manufacturing Facilities
Gone are the days when manufacturing facilities could rely on developing the same product year after year. More targeted therapies that need to be manufactured in smaller volumes for smaller populations means the industry is seeing a transition away from “one-line-one-product” setups in favor of multi-product manufacturing facilities. These sites must be designed to be more agile, with the capability to react to changing demands quickly. The growing trend toward contract manufacturing is also driving the need for more flexible facilities to meet the needs of multiple customers.
Flexibility is key, and modern facilities need to be able to re-orientate their processes according to the requirements of individual products. As a result, sites are now being designed in a way that ensures a high degree of segregation between process steps, provides cross contamination control, and limits product exposure to the environment.
Single-Use Technologies
Aligned with today’s growing pipeline of high potency and biological drugs, the adoption of single-use technologies, such as single-use bioreactors and other unit operations, is having a significant impact on the way that automation is delivered. The integration of process control systems and manufacturing execution system (MES) solutions with start-to-finish technologies and single-use manufacturing platforms is helping the industry to deploy biopharmaceutical manufacturing with increased productivity and efficiency, and at a lower cost, which can significantly reduce the time-to-market for new products.
Both upstream and downstream manufacturing processes benefit from single-use systems. They reduce or eliminate the time required to perform cleaning and steaming, and they allow manufacturers to switch quickly from one product to another, or from batch to batch.
Single-use components are also an enabling technology for smaller scale production of biopharmaceuticals, including antibodies, proteins, vaccines, and cell therapies, which would otherwise be much more difficult to produce. In addition, as the world of gene therapy continues to evolve, the industry can expect to see even greater reliance on single-use technologies. However, as a starting point, many companies may in the first instance choose to pursue hybrid facilities with both stainless steel and single-use components.
Continuous Manufacturing
Batch manufacturing processes have a pre-defined maximum asset utilization on the plant floor. Traditional pharmaceutical companies have in the past been slow to investigate new manufacturing techniques, preferring a more risk-adverse approach to modifying the validated batch manufacturing design.
Cost pressures and the need to find ways to increase productivity have led to the introduction of new continuous manufacturing techniques across a number of unit operations in the life science industry. Oral solid dose tableting lines, continuous API production, and continuous chromatography in biological processes are but a few examples of where continuous manufacturing provides greater productivity for companies. With this also comes new challenges from an automation perspective, not only in the continuous manufacturing process but also in the batch record and genealogy requirements for the product.
Industry 4.0
Industry 4.0 is becoming increasingly important to the continued success and competitiveness of pharmaceutical manufacturers. It refers to new tools and processes that are enabling smart, decentralized production, with intelligent factories, integrated IT systems, the Internet of Things (IoT), and flexible, highly integrated manufacturing systems. For the life science manufacturing industry, it’s not about being new—it’s about using proven solutions and approaches to decision making to improve quality, reliability, and reducing waste. Companies in the life science industry have been collecting and using evidentiary data to improve their manufacturing processes for nearly 40 years and have some of the best quality systems in the world.
Industry 4.0 is simply the latest wave of technological advances that will drive the next phase of pharmaceutical manufacturing. It will enable manufacturers to have full visibility of operations and allow them to be responsive to information, while bringing connectivity of equipment, people, processes, services, and supply chains. Industry 4.0 will take automation to a new level with individual management processes expected to become automated. For example, if a temperature gauge makes a higher than expected reading, the machine will detect this and rectify the situation rather than requiring an operator to intervene and make an assessment about the required course of action.
In addition, future developments may mean that machine learning algorithms will be able to adjust manufacturing lines and production scheduling quickly. New developments will also pave the way for predictive maintenance and the opportunity to identify and correct issues before they happen.
The food and drinks industry is leading the charge in implementing Industry 4.0, with some companies in the sector beginning to use artificial intelligence to improve processes. Similarly, the automotive industry is also making considerable progress in terms of smart devices, the IoT, and achieving connectivity between all systems within a manufacturing plant.
Due to regulatory constraints, the pharmaceutical industry has been slower to adopt this type of cutting-edge technology. While embracing the potential for Industry 4.0 is going to be critical to future operational efficiency for all manufacturers, it may be a long time before the industry is able to complete the digital transformation and have fully automated and connected facilities that can take advantage of all the age of digital manufacturing has to offer.
Leveraging Data & Analytics
While the idealistic end game of fully connected, self-optimizing production processes may be further down the road, the first steps to digital manufacturing are well under way. Automation and technology create the opportunity to leverage data and analytics to improve processes. Often referred to as enterprise Manufacturing Intelligence (MI), access to more meaningful data means a better view of operations, allowing for better analytics and real-time responsive decision-making to drive continuous improvement and operational excellence.
With Industry 4.0 comes the introduction of edge devices; computing to make it easier to connect machines and the ability to create organization-wide data lakes. These edge devices can also be used to run analytics in real time close to the equipment while big data is analyzed in the cloud.
Big data also allows for the creation of digital twins. A digital twin can be made up of end-to-end data in the manufacture of a product where a fleet’s data can be used to find insights. Extension of the traditional “golden batch,” where data was very much process control-based, will be supplemented and surrounded with environmental data, raw material data, training data, and any other digital data available that goes toward influencing the golden batch. With this digital information available across multiple sites, batches and suppliers, sophisticated advanced analytics can provide a digital twin that best represents the golden batch and alert controllers to any problems based on these specific data sets.
Final Thoughts
Automation and other manufacturing systems, such as MES, have the potential to transform processes within pharmaceutical manufacturing facilities, opening the door to fundamental performance improvements. For manufacturers that fail to leverage these technologies, the introduction of new pharmaceutical products may take months or years rather than weeks, and they will likely find themselves falling behind their competitors in the efficiency stakes. Companies that take the initiative early stand to gain the biggest competitive advantage, ensuring they can operate with greater agility, cost-efficiency and compliance.
Author the author: Trevor Marshall is director of enterprise system integration at Zenith Technologies and has worked for over 20 years in the pharmaceutical and biopharmaceutical industry. Working as a Business Unit lead for Zenith Technologies he oversees the delivery of projects globally for the company. He also leads the consulting business, advising clients on best practices for implementation of manufacturing systems encompassing DCS, MES, and Historian systems.
