"Connecting the dots to a digital future, transitioning from data to informed decisions"

The origins of this collaborative Special Issue between the PMTC at the University of Limerick, and the PRST group at Technical University Dublin, began with the development of the PMTC good practice guide to data analytics which was launched in late 2020

“Gaining organisational acceptance of a data analytics programme in Eli Lilly”

This paper describes how Eli Lilly overcame barriers to enable new use of data. This was achieved by adopting a deep understanding of end-user needs and the support of site leaders and end-users to standardise process monitoring. A standard approach of ‘Contexting’, ‘Data-Extraction’, ‘Model build’, ‘On-line Config’, ‘Deploy’, was utilised, using a commercial off-the-shelf software. The paper describes proof of concept demonstrations undertaken and discusses the ingredients to make the journey a succes

“Deployment of data analytics to support manufacturing at janssen”

This paper describes two key areas of value that data analytics supported for Janssen: yield optimisation and Tech. Transfer. By focusing on two key business areas the definition of success and scope was clearly understood by all stakeholders from key business leaders to shopfloor operators. Thus, the value of data analytics was apparent. The paper discusses key pitfalls to avoid and identifies two key investments for success

Data architecture for pharmaceutical product development at Alkermes

This paper describes how Alkermes built a data architecture for efficient management of non-GXP and R&D data. Using a ‘Create’, ‘Store’, Describe’ ‘Access’ stepwise model, the ingredients to making the journey a success are described

Enhancing the capabilities of fluid bed granulation through process automation and digitalisation

Developers, Data Scientists and Data Engineers (Dukart, et al., 2020). Drug manufacturing processes This paper describes a PAT-enabled, digitalised, and automated fluid bed granulation system. A multichannel Near-Infrared (NIR) spectrophotometer and a direct imaging particle size and shape analyser in constant dialogue with the SmartX no-code/low-code platform provide a ground-breaking process automation toolset now located at the Bernal Institute in the University of Limerick. Two sets of results are presented for this study, from two iterations of the Advance Dynamic Process Control (ADPC) controller application. The results demonstrate the direct measurement and control of the product’s critical quality attributes through digitality enabled feedback control of processing setpoints and parameters. The platform controlled the particle size more tightly compared to non-automated control and a more accurate measurement-driven process endpoint for moisture content was achieved. Implementing a digitally enabled control approach can significantly reduce batch to batch variation and greatly improve process performance and product consistency

Sounding out falsified medicines from genuine medicines using broadband acoustic resonance dissolution spectroscopy (BARDS)

The trade in falsified medicine has increased significantly and it is estimated that global falsified sales have reached $100 billion in 2020. The EU Falsified Medicines Directive states that falsified medicines do not only reach patients through illegal routes but also via the legal supply chain. Falsified medicines can contain harmful ingredients. They can also contain too little or too much active ingredient or no active ingredient at all. BARDS (Broadband Acoustic Resonance Dissolution Spectroscopy) harnesses an acoustic phenomenon associated with the dissolution of a sample (tablet or powder). The resulting acoustic spectrum is unique and intrinsic to the sample and can be used as an identifier or signature profile. BARDS was evaluated in this study to determine whether a product is falsified or genuine in a rapid manner and at lower cost than many existing technologies. A range of genuine and falsified medicines, including falsified antimalarial tablets from south-east Asia, were tested, and compared to their counterpart genuine products. Significant differences between genuine and falsified doses were found in their acoustic signatures as they disintegrate and dissolve. Principal component analysis was employed to differentiate between the genuine and falsified medicines. This demonstrates that the tablets and capsules included here have intrinsic acoustic signatures which could be used to screen the quality of medicines