Digitalisation of BioPharma Manufacturing

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Guest Blog by: Siobhan Fleming, Collaboration Manager at Siemens Digital Industries

The extraordinary events of 2020 have made everyone more aware of the complex process involved in identifying, developing and manufacturing vaccines and medicines, and the real race against time that is involved. The world is looking to the biopharma industry for solutions, through testing, repurposed and novel therapies and of course vaccines. How fast the industry can respond to the crisis in the coming months, will shape the outcome of the pandemic and the reputation of the biopharma industry for decades to come.

The industry faces consistent challenges of producing drugs in adequate quality and quantity to keep patients supplied, while also preparing to make new vaccines and therapies, such as for COVID-19. To manage this complexity and prepare for the future, many in the industry are embracing Digitalisation.

Digitalisation means using digital technologies to change business processes and models so that they provide new opportunities to produce value. It goes beyond automation, blurring the digital and physical worlds, to transform the operation by providing new tools – computers and information technology – to change the way business operations are delivered. An early example in biopharma has been the migration from paper to electronic batch records, but today’s technology advances offer even greater opportunities. In the digitalised biopharmaceutical organisation, it is possible to collect, share and analyse data from laboratory, manufacturing and supply chain, and even from the patient, for an end-to-end integrated data set that will inform future product development and approvals.

Many industries have already deployed IT technologies like cloud, big data and advanced analytics, machine learning and artificial intelligence, to transform their operations and drive efficiency, but the life sciences industry has been slower to adopt. This offers incredible opportunity for those organisations that move early to gain competitive advantage with an end-to-end digitalisation and data analytics strategy.

With the first operations established here in the late 1960s, Cork and the South-West region of Ireland is a unique home to thriving clusters in both IT and Biopharma. The area is home to multinational operations for 7 of the top 10 global pharmaceutical companies, and over 30 in total, employing approximately 15,000 people. These local operations have developed deep expertise in bioprocessing and supporting operational technology (OT), with many global Centres of Excellence operating from the region. An equally a strong location for ICT and global business services, the region is a hub for over 60 multinational information technology (IT) companies employing around 30,000 people. This depth of both OT and IT knowledge creates a unique environment for creating fully digitalised biopharmaceutical operations.  

You may have heard of IT/ OT Convergence, whereby OT and IT domains will consolidate at least part of their teams. This can offer incremental improvements but is unlikely to deliver the real transformational change achievable with digitalisation. Instead, industry requires a deep, cross-functional and proactive collaborative approach – IT / OT Collaboration – combining the respective intellectual power, know-how and experience of both IT and OT teams to make the biopharmaceutical operation a fully digital enterprise. Areas of the biopharmaceutical organisation that can benefit from digitalisation, improved data sharing and advanced data analytics, include research and development, drug development, process development, tech transfer, manufacturing and supply chain, and regulatory reporting. Advanced data analytics offers improved insights, opportunities for collaboration and improved decision-making at all stages of the drug lifecycle.

The goal of IT / OT Collaboration is to establish vibrant digital threads of data running transparently, seamlessly, and securely through the business, from lab to factory floor to patient and everywhere in between, even remotely. The Ireland South-West region, with its unique biopharmaceutical and ICT eco-system, is uniquely positioned to leverage this know-how and expertise in such deep collaborations. Supported by organisations such as it@cork, these teams can drive the digital transformation of local biopharmaceutical operations and place Ireland at the forefront of the global biopharmaceutical industry. 

About the author:

Siobhan Fleming, Collaboration Manager at Siemens Digital Industries

For the past twenty years, I have worked with solutions for the local and global biopharmaceutical industry, including traceability, compliance, process control and MES. I am currently focused on collaborations around biopharmaceutical data analytics at Siemens Ireland Digital Industries. BioMAC, developed in collaboration with NIBRT, is a hybrid solution and service for addressing challenges in bioprocessing using advanced Big Data Analytics, machine learning and artificial intelligence. The exciting BioMAC collaboration combines Siemens Industry 4.0 technology with NIBRT’s knowledge of biopharmaceutical manufacturing, statistics and data science to provide a state of art data analytics solution for improved and accelerated process understanding and new opportunities for efficiency.

Siobhan was also part of the panel discussion for the 5th Track of it@cork TechFestwhich was on Digitalisation of BioPharma Manufacturing, the recording can be viewed here: it@cork YouTube