Distinguishing between the buzzwords, philosophies and reality in life science manufacturing has been critical, says Joe Haugh, CEO of Zenith Technologies: “It’s easy to talk about these industry terms without understanding their true meaning or implications for our customers.”
Discussing how the company’s business has evolved during the past 12 months to better meet the needs of its customers, as well as the trends that are shaping the industry through 2020 and beyond, this article examines Zenith’s experiences in 2019, in which 1.2 million engineering hours were booked to more than 1481 life science projects.
Towards resilient manufacturing
“When we look at the breakdown of project work completed in 2019 year, we see a significant increase in cyber security or resilient manufacturing consultancy,” notes Joe. Perhaps not surprising considering a recent Deloitte report that cites the pharma sector as the primary target for cybercriminals looking to steal intellectual property.1 The estimated cost of cybercrime to the market is suggested to be valued at US$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," says Joe.
It’s easy to talk about these industry terms without understanding their true meaning
"Our customers are adopting such practices as robust cybersecurity maintenance processes (ensuring that they have the highest level of protection at all times) cyber hygiene standard practices (to prevent operational technology [OT] networks being compromised) and control systems security responses (including a suite of prepared tools and practices to be deployed when an intrusion is detected),” Joe explains.
Joe continues: “Most of the cybersecurity 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 wherein the cybersecurity staff and the infrastructure personnel have combined to be a single unit.”
Flexible production strategies
“In terms of our biopharma customers, we’ve also seen an increased need from higher levels of increased flexibility with simplified production strategies,” comments Joe, adding: “One area of growth in particular has been the adoption of single-use (SU) technology.” SU or disposable bioprocessing equipment is now used widely throughout preclinical and clinical manufacturing and is increasingly being adopted for commercial-stage production.
“Our customers have quickly realised that it offers faster turnaround times for smaller batches because there’s no need to clean, sterilise or validate it prior to use. We’ve also seen an increase in smaller production facilities and automated labs using cell and gene therapies for personalised medicines."
"Although this strategy offers more flexibility, many of our customer have experienced a rise in logistical complexity owing to the greater number of components and consumables required,” says Joe. He notes that the company is also starting to work with a growing number of contract manufacturers, commenting: “These facilities need to be flexible enough to produce multiple medicines to meet industry demands.”
During the last few years, continuous manufacturing (CM) has moved out of preclinical and clinical production to include full-scale processing for both drug substances and drug products.
Says Joe: “We’ve recently witnessed a marked shift to CM, with many of our customers benefiting from increased optimisation and production cost savings of 15–30%, as well as advantages such as an overall equipment efficiency (OEE) increase of 75% in many cases, a 60–80% reduction in end-to-end batch lead times and significant reductions in inventory and utility costs. There is also a requirement for smaller facilities being needed to house this type of plant.”
The move towards CM has also followed the larger theme of digitalisation. The convergence of information technology and operational technologies (IT-OT) has the potential to enable new capabilities across the life science sector for years to come.
Unlocking the potential of data
As previously mentioned, another key driver is Zenith customers wanting more out of the data they have. “Our project delivery has highlighted that the focus on 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,” advises Joe.
“The general discussion and project objectives have been about delivering answers to the big questions, such as how a certain batch is doing and whether any deviation has affected product quality.”
Our customers require a narrow, deep focus, not a broad and superficial one.
“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 that operators, supervisors and executives have access to the data they require to build process and business excellence,” he continues.
“From our experience, most customers are interested in the integrity and contextualisation 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 Big Answers as opposed to Big Data.”
Delivering Life Sciences 4.0
“This year will see us continuing to develop our offering to meet the changing needs of our customers,” says Joe, adding: “By joining forces, Zenith Technologies and Cognizant can truly transform the life sciences industry and help to develop the digital factories of the future.”
He concludes: “By bridging the IT-OT divide, we’ll enable our customers to make tangible business improvements and obtain a new level of insight. Our combined approach will enable them to leverage data analytics, cloud technology and IoT capabilities to truly deliver on their Life Sciences 4.0 goals and ambitions.”