Barry Heavey outlines how digitisation and data analytics are bringing pharma and biotech manufacturing into the age of industry 4.0, and the role Ireland is playing in this global shift.
The Irish life sciences manufacturing sector has shown extremely strong growth in recent years with major investments from a number of large multinational pharmaceutical companies such as BMS and MSD, and the sector recording exports of €67.8bn in 2017.
With such a vibrant sector, there are a number of success stories of indigenous Irish companies that have developed offerings to support the cluster of multinationals. One such company that caught Accenture’s attention is Enterprise System Partners (ESP).
Digitising global manufacturing
ESP has been focused on helping pharma companies to embrace digitisation and industry 4.0 concepts for several years. It has spread its wings from Ireland to having operations in the US and Europe, supporting large companies in bringing digitisation to its global manufacturing network. (Earlier this month, Accenture announced that it has agreed to acquire the Cork-based company amid continued investment in Ireland, underscoring our commitment to one of Ireland’s most important and growing industries.)
ESP was established in Cork in 2003 when the founders Liam O’Brien, Diarmuid Quinn, Eddie Lawlor and Dermot O’Callaghan saw the opportunity for a specialist consultancy firm focused on helping pharma companies utilise manufacturing execution systems (MESs) to move their manufacturing from paper to electronic batch records. It proved to be a wise move as its client companies embraced the use of MESs, resulting in ESP growing to the 200-person operation it is today.
The MES market was valued at $7.6bn in 2015 and is estimated to reach $18.22bn by 2022. Life sciences is a key subsector within the MES market; the high level of regulatory focus on production of high-quality and consistent medicines means that precision and robust record-keeping in manufacturing is vitally important. ESP also diversified into supporting pharma companies in implementing serialisation – the ability to track and trace all product manufactured – to lower the risk of counterfeit medicines entering the marketplace.
Increasing complexity in pharma and biotech
Complexity is growing in pharma manufacturing as evidenced by the fact that the bestselling drug in 2007 (Atorvastatin, sold under the brand name Lipitor) contained 33 carbon atoms, whereas the bestselling drug today (Adalimumab, sold as Humira) contains more than 6,000.
These new drugs are also emerging from R&D at a faster pace, with cancer research being an area where new drugs are regularly fast-tracked to approval based on their impressive results in trials.
This means that companies have less time to develop manufacturing processes for drugs that are increasingly complex. Hence old, analogue methods for managing data and knowledge on manufacturing just won’t cut it any more.
Drugs are also increasingly targeted at smaller patient populations and are highly potent, so do not need to be made in large quantities. This can result in many facilities becoming multi-product production sites, with a variety of processes, recipes and flexible equipment trains. A digital architecture can help to ensure that sites are able to cope with moving from high-volume, low-mix production, to a low-volume, high-mix paradigm.
An extreme example that encapsulates all of the above is the emergence of cell therapy such as chimeric antigen receptor T cells, or CAR T cells. These therapies are extremely complex in that they are made with living cells that have been genetically modified. They have emerged extremely rapidly in recent years, from academic research in University of Pennsylvania in 2011 to FDA approval in 2017.
CAR T-cell therapies are the ultimate example of low-volume, high-mix production, with each batch being made for an individual patient. This creates enormous complexity for manufacturing, quality control and supply chain.
Augmenting the worker
Automation has already been well established in the pharma manufacturing space, but the industry continues to need humans in the loop to run production. As batch sizes get smaller, the mix of products greater and new products coming through the pipeline more quickly, companies are moving to so-called factory-of-the-future technology such as single-use systems. In this type of ‘factory of the future’ the human remains as important as ever; there are limitations to the use of automation in a flexible factory based on single-use systems, and operators provide more flexibility and agility.
The MES can help connect different islands of automation and augment the worker in interacting with these systems. Batch records can be compiled electronically rather than on paper, and the worker is guided through a step-by-step process for batch execution, minimising the potential for error. Furthermore, novel user interfaces – such as mobile interfaces, assisted or augmented reality, and voice interaction with the MES – are now being trialled.
Unleashing data analytics
MESs are used to create an electronic batch record of all the steps performed in the manufacturing process. Lab information management systems (LIMSs) are used to record the laboratory data on raw materials used, process samples and final product produced. Ultimately, these manufacturing and laboratory datasets must be combined for audit, but this data can also be combined and analysed to create value.
Advanced analytics between these datasets from the process and the lab can surface insights, correlations and trends that may be important for the manufacturer to fully understand how their process is performing over time, identify root cause for problems, improve productivity and robustness in a data-driven way, and mitigate the risk of batch failure or a delay in batch release. For products that can be life-saving for patients and have multibillion-dollar annual sales, these data-driven insights are vital.
In 2017, Accenture acquired the US company LabAnswer, which shares many similarities with ESP but specialises in LIMSs rather than MESs. Accenture has now established a LIMS centre of excellence in Ireland, working with the teams at Accenture Digital and The Dock, Accenture’s flagship R&D and global innovation centre based in Dublin, to apply technology such as machine vision, augmented and virtual reality, and artificial intelligence on top of the lab IT core systems.
Where to next?
As research accelerates in life sciences, Accenture sees a need for pharma companies to break down the silos between their R&D, manufacturing and quality control teams. There is a need for more integrated systems to support collaboration across different teams, different geographies and across the life cycle of a product.
Data is the ‘digital thread’ that supports knowledge development, management and sharing between R&D, manufacturing, quality and supply chain; between biochemists, chemical engineers and data scientists; and between the internal and external workforce.
As for the Irish pharma cluster, it is in an enviable position as a world leader in pharma manufacturing. Strategic Government investments (such as the Science Foundation Ireland pharmaceutical research centre SSPC and the IDA Ireland-funded National Institute for Bioprocessing Research and Training) and successful indigenous companies (such as ESP and APC) bode well for the sector here. Ireland is well positioned to be a leader in the industry 4.0 space in life sciences.