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MES Systems are the key driver for modern industries

By David Gredal

ProjectBinder MES Partner

Manufacturing Execution Systems in the pharmaceutical industry

At the present time, if manufacturing companies wish to retain or strengthen their market position, they must focus, in particular, on efficient production and process procedures. Production processes and product information have to be fully monitored and weaknesses minimised continuously. This is the only way to reduce manufacturing costs and maintain product quality. Nevertheless, a seamless data environment is essential to supply the right information for process optimisation. In recent years, manufacturing execution systems have become an established solution for these complex tasks.

David Gredal is a MES Partner in ProjectBinder with a demonstrated history working 20+ years with MES Systems hereof the last 12 years in the pharmaceutical industry. David holds a master’s degree in business administration and computer science from Copenhagen Business School. For the past 7 years, David was leading the Novo Nordisk Center of Excellence for MES systems and overall responsible for the MES strategy and MES implementations in Novo Nordisk worldwide. As an expert in the field, we have asked David about the keys, the functionalities and the upcoming challenges of MES.

1) Why is MES needed?

Manufacturing Execution Systems (MES) are essential in driving the shopfloor performance of pharmaceutical companies to the next level. MES Systems will bring some key benefits to the shopfloor simplifying the operations. 

MES systems with its build-in poka-yoke capabilities guide the operators on the shopfloor to perform the right tasks in the right sequence dramatically reducing expensive deviations. As fewer errors happen it lowers re-work and scrapped batches.

2) How can MES implementations change business processes?

When implementing MES systems it can help the business to streamline their business processes by removing waste (over-documenting). 

It is also a golden opportunity to adopt to industry best practices and standardise their operations across the shop floor and production facilities. It will be possible to have e.g., a packaging line operating in a nearly identical way as a similar packaging line in another production facility in another country.

3) How are the life science and pharma industry affected by the current crisis?

The pharma industry was somewhat affected at the beginning of the covid-19 crisis in the sense that many pharmacies and patients were panic buying. After the first peak in the spring, there has been a flattening curve. Now their main focus is to be able to produce and keep their staff healthy. Hence, they are very careful in the segregation of staff and who is allowed to enter production facilities.

4) What are the challenges for the industry in the coming years?

Seen from the production perspective some of the bigger challenges that most pharmaceutical companies faces are:

  • Legacy systems that required updating or replacement. There are many systems that either are not supported any longer or it gets increasingly more and more difficult to find people that can maintain the legacy systems. The systems will more and more become a burning platform – increasing the operational risk.

 

  • Another challenge is the time to market. It is not uncommon to see lead-times of up to 1 year from when the initial Active Pharmaceutical Ingredient (API) was produced until the final production batch is delivered to the market. There is a huge amount of capital tied-up in the supply-chain. Lead-time for products needs to be reduced dramatically.

 

  • Lastly when investing in new production facilities or production lines then it can take years before the first sellable product is released from the new facility/line. They need to find new innovative ways of bringing the time-to-market down to be able to react to the market faster.
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5) Where do you expect the next investments in the industry?

The production in the pharmaceutical industry has already started to innovate and adopt some of the digital trends of industry 4.0.

For the companies to get the true benefit of the new solutions and be able to scale this across their production plants they need to upgrade their IT/OT infrastructure across facilities.

They need well maintained standard systems so they easily can scale with new innovation on top. As part of this journey, they need to eliminate all paper and go digital with connected systems. Connected MES systems are the key driver for this.

In parallel with lifting/replacing legacy systems and implementing MES systems they will invest in industry 4.0 technology where some of the trends are…

Analytics & Artificial Intelligence

Will bring important insights and improvements in many fields of industrial automation, from the initial design to more precise preventive maintenance systems and application to artificial vision systems.

Digital Twins

It allows companies to create digital replicas of their productive ecosystems in such a way that they can predict virtually everything that will happen in the physical world. In the future, we also expect that a large portion of the validation effort can be performed on the digital twin long time before the physical equipment enters the production facility.

Smart (and dark) factory

The well-known connected or intelligent factory aims at intelligent working models of people that allow them to carry out their tasks from remote areas by using advanced technology that keeps operators connected. Dark factory or lights out – means that the factory runs completely automated without any humans in the facility everything is controlled remotely.

6) With regards to manufacturing IT do you think pharma manufacturers are following the latest digital and remote solutions trends?

The short answer is “no” – but with a twist. 

The pharma industry has traditionally been slow followers to new technology – All technology needs to be well-proven before adopting to it – and even in this case many in the industry still like to copy from previous projects. 

The recent years there has however been a shift and willingness of taking much more risk and exploring Industry 4.0 – the ISPE has formed the Pharma 4.0 Operation Model which basically is Industry 4.0 + ICH guidelines, which will support the industry in this journey.

7) After many years working for a great company like Novo Nordisk you are now starting a new professional adventure with ProjectBinder, How is ProjectBinder positioned to face the upcoming challenges in the MES area?

One of the reasons why I left Novo Nordisk and joined ProjectBinder was the company’s interesting profile within the OT/Automation area with an office in the Nordics and one in the South. By bringing this together ProjectBinder has a unique opportunity to build capabilities across that can serve the high demand for MES systems digitalising the shop floor. 

I’m really looking forward to this journey of building a strong team across North and South that can serve pharmaceutical companies on the MES and Industry 4.0 journey.

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