The fourth industrial revolution, or Industry 4.0, is the realization of the digital transformation – harnessing the power of data and smart manufacturing to enhance productivity, flexibility and agility. How has Industry 4.0 been adopted in the life science industry? And how can it help us to deliver medicines more efficiently to patients?

I joined a panel discussion at Advanced Therapies Integrates 2022 to explore these important questions. The session was facilitated by Kwok Pang, COO and Co-Founder at Autolomous. The other panellists included: Antoine Espinet, Co Founder & Chief Executive Officer at MicrofluidX; Gaurav Venkataraman, Cofounder and Chief Executive Officer at Trisk Bio; Verity Nancollis, Associate Director, Biologics Development, Manufacturing & Control (BDM&C) at Pharmaron; and Andreea Iftimia-Mander, Director of Lifesciences at Biomatics.


Digitise with the patient in mind

Digital tools will enable us to manufacture faster and more accurately. Companies can’t afford to ignore it; if you don’t have digitisation, somebody else will outcompete you.  But it is important to remember that the tools themselves are not the outcome – automation is only valuable if it will ultimately benefit the patient. The key is to start with the end goal in mind.

Gaurav Venkataraman emphasised the importance of taking time to understand the problem you’re trying to solve and identifying the parts of the process where robots can offer a valuable replacement. He explained that digitisation can improve reliability, but there is a trade off with flexibility. For this reason, digitisation is most useful during the scale up phase when you’re looking to reduce cost, achieve consistency of manufacturing and meet regulatory requirements. Adding a CDMO point of view, Verity Nancollis explained the need for a well thought out digitalisation strategy that matches the business strategy, warning against digitalising for the sake of it.


Barriers to digitisation

Implementing digitalisation is not without its challenges. Current barriers to biomanufacturing 4.0 include a lack of online reliable sensing technologies, heterogeneity inside bioreactors, dispersed data across multiple instruments and a lack of data analytics in bioprocessing.

Antoine Espinet summarised the challenges into three fundamental questions: What do you measure, how do you measure it, and how do you exploit the data? While there is much hope and excitement around machine learning and AI, he suggested that the industry first needs to focus on getting off paper and into digital data recording; we need to walk before we can run.

Another major challenge facing the advanced therapies sector is a shortage of talent. Data is only useful if we can harness it effectively, requiring an in depth understanding of both biological systems, such as cell culture, and software engineering. Gaurav Venkataraman suggested there is an opportunity to attract high end software engineers who are looking to move out of tech and transfer to an industry where they can make a meaningful difference. There’s a large opportunity for software engineers to create value in the bioprocessing industry.


The future of biomanufacturing

The session ended with a discussion of decentralised, localised manufacturing. Andreea Iftimia-Mander explained that decentralised manufacturing will be the future for ATMPs because you can’t always bring the patient where the therapy is. As we move towards personalised and autologous therapeutics, pharma will have to become more closely integrated with the healthcare system, acting as a tool of the physician rather than as a vendor to the physician.

However, the panel agreed that certain limitations such as quality control and requirements for maintenance will necessitate a certain level of human intervention, meaning that a partly decentralised model is the likely next step. For now, we still need excellent people to build the robots, to maintain the machines and to train the algorithms. While digitisation will undoubtedly bring benefits to the life sciences, it remains crucial to maintain a pool of talent around the technology.


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