Evolving World of Pharma: A smarter approach to manufacturing

In recent months we have discussed various ways in which the pharma industry is adopting ground-breaking technologies. From the transformational effects of artificial intelligence on drug discovery and development, to personalized medicine, serialization and supply chain management, we truly are seeing an evolving world of pharma, driven by Big Data and related technologies.

A smarter approach to manufacturing By Sarah Harding

Another important area in which Big Data is already having a huge impact is manufacturing. Considered the fourth industrial revolution, or ‘Industry 4.0’, the digitization of manufacturing is now picking up speed and many companies across numerous industries are starting to realise the benefits: higher quality products, produced more efficiently, more ‘in-spec’ and more economically, with better process safety.

In fact, the digitization of manufacturing is not in itself a new concept. As far back as the 1940s, manufacturers in the USA were the first to use ‘statistical process control’ (SPC) to reduce variation in weapons equipment. However, while a small number of companies recognised the cost and efficiency benefits of applying processes such as these, nothing really drove Industry to adopt them as standard.

Until now.

The difference today, and the reason digitization is finally having a transformational effect on our manufacturing, is that we now work in a world in which regulatory bodies – especially in the pharma industry – are demanding greater consistency, better traceability, improved safety and reduced waste. All of these demands can be met most easily and simply through the application of data analytics in manufacturing.

“The FDA and EMA have been pushing the pharma industry to digitize for well over ten years,” says Louis Halvorsen, Chief Technology Officer (CTO) at NorthWest Analytics (Portland, OR, USA). “For example, look at real-time generation of Continued Process Verification (CPV) and batch reports – the only practical way you could deploy this is through a fully digitized system. Regulatory agencies are making it clear that they expect monitoring systems to be automated and real-time, and this requires manufacturing analytics.”

Manufacturing analytics is the science of drawing insights from raw process information sources. The majority of data collected from any manufacturing plant offers little value in its raw, unprocessed state – just the sheer volume of it can leave the most experienced operator at a loss to understand its meaning. However, applying the right tools to those data can reveal trends and metrics that would otherwise be lost in a mass of dots and lines. Various software packages that capture and analyze big data are already widely available, making sense of data and converting them into value.

From start to finish, manufacturing analytics can reduce the risk in pharma by, for example, checking the quality of incoming ingredients, enabling companies to see and proactively address process drifts, improving production performance, and easing the burden and cost of regulatory compliance. The real-time aspect of these insights is particularly crucial in the pharma industry – you really want to know if anything is wrong with your product before it ends up in distribution! Manufacturing analytics can offer insights into processes, to help operators and engineers better understand what is happening in their plants and address any deviations as soon as they arise, before they cause real problems.

The advantages of manufacturing analytics seem so obvious that it’s actually difficult to see how pharma companies not using it are still managing to comply with regulations and/or maintain any competitive edge in this evolving industry. As with many of the technologies discussed in this column, those companies missing the chance to adopt manufacturing analytics are going to find themselves at a significant disadvantage in the very near future.  When it comes to pharma manufacturing, the only smart way forward is digital.

Author biography

Sarah Harding, PhD

Sarah Harding worked as a medical writer and consultant in the pharmaceutical industry for 15 years, for the last 10 years of which she owned and ran her own medical communications agency that provided a range of services to blue-chip Pharma companies. In 2016, she began a new career in publishing as Editor of Speciality Chemicals Magazine, and has more recently taken up the role of Editorial Director at Chemicals Knowledge. She continues to also provide independent writing and consultancy services to the pharmaceutical and speciality chemicals industry.

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