Technology assists life sciences companies to conquer global challenges

By Ariel Lasry, Rockwell Automation EMEA Vertical Leader, Life Sciences

Thanks to new technologies, progressive companies are seeing manufacturing as a strategic asset and are investing in automation systems and MES, as well as improving processes which allow them to prepare for major industry changes.

An unprecedented set of conflicting challenges face the Life Sciences industry today. New economic pressures are pressing down, with the threat of government restrictions on pricing, patent expiration and a shrinking  pipeline of blockbuster drugs combined with the undermining of profits from counterfeit drugs.

The natural defence to these threats is to improve operational competitiveness, driving out inefficiency from elements such as the manufacturing process. Unfortunately, the tightly regulated world of the Life Sciences industry means that these manufacturing savings have been difficult to achieve. Over many years manufacturing processes have been designed for validation, rather than efficiency; validation that helps to make sure that the essential regulatory and quality aspects of pharmaceutical manufacturing can be stringently met but at the same time means that the flexibility and agility adopted by other manufacturing industries has been difficult to achieve.

However, new advances in technology allow Life Sciences companies to apply the benefits of the latest manufacturing technologies to their sector. Using these solutions, progressive Life Sciences companies are seeing manufacturing as a critical strategic asset and are investing in automation systems, such as Manufacturing Execution Systems, as well as improving processes which allow them to prepare for, and capitalise on, major industry changes.

Using its long history of experience in the industry, Rockwell Automation has been developing specialist systems for the sector to help companies use automation, information and power technology to improve operations for competitive advantage across the product life cycle – from formulation to factory.

Serialisation to address the threat of counterfeiting

The threat to patient safety and the economic impact of drug counterfeiting has become a priority issue. Whilst governments and pharmaceutical companies have been looking at the regulatory and industry issues, Rockwell Automation has been creating global technology solutions for pharmaceutical manufacturers to address  the issue of serialisation. Efforts have concentrated around the need to create and track serialisation for each product, allowing a drug pedigree to be established. A drug’s pedigree represents the complete history of  a given product’s chain of custody, from the manufacturer to the point of dispensing. Rockwell Automation’s solution consists of three major elements:

• The Shop floor HMI (Human Machine Interface) components are required to set-up and visualise the serialisation process

• The automation layer controls printers, scanners, cameras and out-sort activities on the production line. The automation layer controls the application and verification of the barcodes or RFID tags applied to the units and documents the physical results in a real-time environment

• Plant layer Tracking & Tracing management. At the plant level, Rockwell Automation provides manufacturers with the capability to aggregate product serialisation and nesting information into ePedigree data

Globalisation benefits delivered with specialist applications

To address the economic pressures of globalisation and to help improve operational competitivenes, Rockwell Automation has developed FactoryTalk Pharma Suite. This specialist solution delivers all the benefits of the leading MES platform FactoryTalk from Rockwell Automation, alongside tailored applications based on the company’s long-term experience in developing and deploying software and systems for the pharmaceutical and biotech industries. As a result, the solution can be easily scaled to meet the needs of small or large organisations and can help deliver a reduced total cost of ownership over its lifetime through the use of industry-standard technology. For example, a major pharmaceutical company projects savings of $1.5m on labour, a 5% reduction in its Work-In-Progress inventory and first time quality improvements with its validated MES system. In another example, an organisation reduced its batch cycle times by 32% with the introduction of  the Batch Record System from Rockwell Automation. Finally, another organisation saw its WIP inventory reduce by 35% and cycle times fall 15-20% with a validated production control and monitoring solution.

PAT services deliver practical results

The use of Process Analytical Technology (PAT) services has also been used by Rockwell Automation as a mechanism to design, analyse, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA). Using PAT consulting, Rockwell Automation has managed to help reduce a major laboratories’ process variability and the results were so impressive that the process and findings have since been presented to the United States Food and Drug Administration for consideration as best practice.

Speed of commercialisation critical

In another area, the increasing speed of scientific advances and rapid development of new targeted treatments has required businesses to continually look for ways to rapidly respond to market changes whilst maintaining quality and compliance and shortening time to commercialisation.  Working with an organisation in Germany, Rockwell Automation was able to integrate PAT with Electronic Batch Record systems in clinical trials to cut the scale-up time to commercialisation and working with another global pharmaceutical company increased research development throughput by 20% with new recipe management and EBR systems.
This breadth and depth of manufacturing experience, combined with the world’s most versatile control and information system architecture and a global deployment capability has made Rockwell Automation an ideal partner to address the challenges of the Life Sciences industry.

Globalisation benefits delivered with specialist applications

To address the economic pressures of globalisation and to help improve operational competitivenes, Rockwell Automation has developed FactoryTalk Pharma Suite. This specialist solution delivers all the benefits of the leading MES platform FactoryTalk from Rockwell Automation, alongside tailored applications based on the company’s long-term experience in developing and deploying software and systems for the pharmaceutical and biotech industries. As a result, the solution can be easily scaled to meet the needs of small or large organisations and can help deliver a reduced total cost of ownership over its lifetime through the use of industry-standard technology. For example, a major pharmaceutical company projects savings of $1.5m on labour, a 5% reduction in its Work-In-Progress inventory and first time quality improvements with its validated MES system. In another example, an organisation reduced its batch cycle times by 32% with the introduction of  the Batch Record System from Rockwell Automation. Finally, another organisation saw its WIP inventory reduce by 35% and cycle times fall 15-20% with a validated production control and monitoring solution.

PAT services deliver practical results

The use of Process Analytical Technology (PAT) services has also been used by Rockwell Automation as a mechanism to design, analyse, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA). Using PAT consulting, Rockwell Automation has managed to help reduce a major laboratories’ process variability and the results were so impressive that the process and findings have since been presented to the United States Food and Drug Administration for consideration as best practice.

Speed of commercialisation critical

In another area, the increasing speed of scientific advances and rapid development of new targeted treatments has required businesses to continually look for ways to rapidly respond to market changes whilst maintaining quality and compliance and shortening time to commercialisation.  Working with an organisation in Germany, Rockwell Automation was able to integrate PAT with Electronic Batch Record systems in clinical trials to cut the scale-up time to commercialisation and working with another global pharmaceutical company increased research development throughput by 20% with new recipe management and EBR systems.
This breadth and depth of manufacturing experience, combined with the world’s most versatile control and information system architecture and a global deployment capability has made Rockwell Automation an ideal partner to address the challenges of the Life Sciences industry.

About the author

Ariel Lasry, Rockwell Automation EMEA Vertical Leader, Life Sciences