2020 - a year for 'big answers' rather than 'big data'

Zenith Technologies CEO, Joe Haugh, takes us through how the business has evolved this year, to better meet the needs of its customers, as well as the trends they see shaping the industry through 2020 and beyond.

Distinguishing between the buzzwords, philosophies and reality in life sciences manufacturing has been critical; it’s easy to talk about these industry terms without understanding their true meaning or implications for our customers.

In this article we look at how our business has evolved this year, to better meet the needs of our customers, as well as the trends we see shaping the industry through 2020 and beyond. Our thoughts are based on Zenith’s experiences in 2019, in which 1.2 million engineering hours were booked to over 1481 life sciences projects.

A drive towards resilient manufacturing

When we look at the breakdown of project work completed this year, we see a significant increase in cyber security or resilient manufacturing consultancy. According to a Deloitte report: Cyber & Insider Risk at a Glance: The Pharmaceutical Industry the pharma sector is the primary target for cybercriminals looking to steal IP – the estimated cost of cyber crime to the market is suggested to be $18 billion in 2020.

In response to this developing market, we have seen a greater prominence of cyber engineering strategy project work filtering down to us. Our customers are adopting such practices as; robust cyber security maintenance processes (ensuring customers have the highest level of protection at all times,) cyber hygiene standard practices (to prevent compromise of operational technology [OT] networks,) and control systems security responses (including a suite of prepared tools and practices to be deployed when an intrusion is detected.)

Most of the cyber security work we completed in 2019 focused on the design phase and the inclusion of cyber considerations into OT project deployment strategies. We see this trend continuing into 2020. Our projects now often include a ‘Secure Infrastructure’ team where the cyber security team and the infrastructure team have combined to be ‘One Team’.

Increased flexible production strategies

We have also seen an increased need from our biopharma customers, for increased flexibility with simplified production strategies. One area of growth has been through the adoption of single-use technology.

Single-use or disposable bioprocessing equipment is now used widely throughout preclinical and clinical manufacturing and is increasingly being adopted for commercial products manufacturing. Our customers have quickly realised that it offers faster turnaround for smaller batches due to the avoidance of cleaning, sterilisation and validation prior to usage. We have also seen an increase of smaller production facilities and automated labs utilizing cell and gene therapies for personalized medicine approaches. Although this strategy is giving increased flexibility many of our customers are seeing an increase in logistical complexity caused by the increased number of components and consumables required.

We are also starting to see the number of contract manufacturers we work with has been on the rise. These facilities need to be flexible enough to produce multiple medicines to meet industry demands.

Continuous manufacturing

This year we have witnessed a shift to continuous manufacturing, with many of our customers seeing increased optimization and cost savings as a result. Over the last few years, continuous manufacturing has moved out of preclinical and clinical manufacturing include full-scale production both in drug substance and drug product manufacturing. They have seen benefits including; a reduction in production costs of 15-30%, increased overall equipment efficiency (OEE) of 75% in many cases, a 60-80% reduction in end-to-end batch lead time, as well as significant reductions in inventory and utility costs. There is also a requirement for smaller facilities being needed to house this type of plant.

A move towards continuous processing has also followed the larger theme of digitalisation. The convergence of IT and operational technologies (IT-OT) has the potential to enable new capabilities across life sciences for years to come.

Unlocking the potential of data

As previously mentioned, another theme we have seen is our customers wanting more out of the data they have. Our project delivery has highlighted that the focus in manufacturing data analysis is about quality, not quantity. Engineers need fewer variables and more data points for those variables to work more effectively and draw genuine conclusions from data. Our customers require a narrow, deep focus – not a broad and superficial one. The general discussion and project objects have been about delivering answers to the big questions, ‘how is my batch doing,’ and ‘has this deviation affected product quality.’

Our customers need the capability to derive genuine and actionable intelligence from their data – not to just access and compile it. In this sense digital data strategies need to be built in at the project Basis of Design (BoD) to ensure operators, supervisors and executives have access to the data they require to build process and business excellence.

From our experience our customers are interested in the integrity and contextualization of their data to ensure they get the most value out of what they have, thus unlocking the value and power of their data.

In 2020, our life sciences customer base will be demanding these ‘big answers’, rather than ‘big data’.

Delivering Life Sciences 4.0

2020 will see continued development of our offering to meet the changing needs of our customers. By joining forces Zenith Technologies and Cognizant can truly transform the life sciences industry and help develop the digital factories of the future. Bridging the IT-OT divide will enable our customers to make tangible business improvements and obtain a new level of insight. Our combined approach will enable our customers to leverage data analytics, cloud technology, and IoT capabilities, to truly deliver on their Life Sciences 4.0 goals and ambitions.