Researchers and industry have developed a guide to data analytics for pharmaceutical manufacturing
NINETY percent of the data in the world has been created in only the past ten years, and it’s estimated that 175 trillion gigabytes of data will be created by 2025. Unsurprisingly, organisations large and small are increasingly positioning themselves with a greater drive to extract value from their data.
Data becomes knowledge through the vehicle of data analytics and knowledge supports the development of value. Creating the culture, the skills, and the infrastructure to readily support descriptive, diagnostic, predictive and prescriptive analytics will be the work of the coming decade as new knowledge drives decision-making.
When it comes to manufacturing medicines, greater implementation of data analytics across the pharma/biopharma manufacturing sector has the potential to deliver more value for business and also for patients – by reducing the risk of product quality issues arising during manufacture, by enabling greater flexibility to respond to market demands and by supporting strategies to mitigate drug shortages in supply chains. In the drive to expand the use of data analytics to create value for both business and patient, maintaining a frequent, timely and clear dialog between manufacturer and regulator is critical.
The Pharmaceutical Manufacturing Technology Centre (PMTC), in collaboration with its industry partners has created A Guide to Data Analytics for Pharmaceutical Manufacturing (pictured). Compiled with over 400 hours of industry contribution, including the views of 14 multinationals and small-to-medium enterprises across surveys, focus groups and case studies, the guide has been written to support the increased implementation of data analytics across the pharma/biopharma manufacturing sector. The guide aims to encourage discourse, so that the sector may begin to “speak the same language”, on the topic of data analytics by clarifying terminology, by highlighting and overcoming some of the business and technical challenges to implementing data analytics, and by bringing to light regulatory concerns and opportunities relating to the expanded use of data analytics across the sector.
The manufacture of safe medicines requires considerable regulatory oversight, adding complexity, which is not reflected in other sectors, and so, the guide was also reviewed in consultation with the Health Products Regulatory Authority of Ireland. There are 51 terms defined and referenced in the guide and the detailed case studies comprise almost 45% of the 80-page document. The PMTC is seeking to continue to benchmark the use of data analytics, both within pharma and across other sectors and to support companies to navigate some of the complexities and regulatory considerations unique to the pharma/biopharma context.
Sitting at the interface of industry and academia, the PMTC supports the pharmaceutical manufacturing industry and its supply chain to solve problems, while differentiating itself by focussing on industry-informed research, where programmes are driven by real market needs defined by industry. Since 2013, the PMTC has established itself as a progressive, agile, strategically relevant, and industry-informed research centre, focussed on developing advanced technology solutions for all stages of pharmaceutical manufacturing. Situated within the Bernal Institute at the University of Limerick, we reside in a world class facility, our research team are experienced senior and post-doctoral level researchers with extensive R&D and direct industry experience. Our research outputs have improved efficiencies across pharmaceutical plant cleaning and include process innovation for different unit operations. These outputs have been major drivers of the reported economic impact of the PMTC, with many companies reporting significant savings due to their implementation.
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