Broadly speaking, Industry 4.0 refers to the ongoing automation and digitalization of manufacturing and industrial practices, benefiting from smart tech. In biopharma, it offers the chance to improve quality and supply as well as reducing costs.
And yet the sector is behind other advanced manufacturing industries when it comes to adopting these disruptive technologies.
Helping drive the industry forward will be a change of mindset among biopharma professionals. And this is not just about getting grips with new tech or new ideas - it's about being attentive to emerging ideas from around the world, as well as being prepared to look outside the biopharma industry for inspiration.
And it's also about being willing to work together and collaborate with stakeholders across the board.
Embrace global collaboration
The pharma industry has long been known as being particularly protectionist. There’s been something of a shift in recent years – driven by continued globalization and then the pandemic, with companies willing to work together to share tech and help develop medicines as quickly as possible - but a protectionist element remains embedded in the industry.
Those working in digitalization need to challenge that way of thinking: with Bioprocessing 4.0 by definition being about new ideas and new technologies.
“Where do you find these ideas? That goes back to globalization, and thinking about not being in a protectionist environment,” Mohamed Noor, digitalization manager for Ireland’s National Institute for Bioprocessing Research and Training, told us ahead of his presentation during BioPharma-Reporter’s free-to-attend ‘Bioprocessing 4.0’ webinar next week.
“COVID has really been an eye opener. Even if you were the best company in the world, making all the vaccines for years, suddenly you realize there’s a new modality.”
The NIBRT, for example, has a raft of collaborations both in its home of Ireland (which hosts a number of multinational biopharma companies) and globally to help it understand global trends and new ways of working.
That includes partnerships with the Jefferson Institute for Bioprocessing in the US, another with the Canadian Academy for Skills and Training in Lifesciences (CASTL), the University of Technology in Sydney, the Biologics Research Training Academy in Guangzhou, China, and K-NIBRT in Incheon, South Korea.
Described as one if the first collaborations of its kind globally, Boston Consulting Group and Ireland’s National Institute for Bioprocessing Research and Training (NIBRT) created the Biopharma 4.0 Alliance for Digital Innovation in Operations in 2020.
This Innovation Center showcases the latest 4.0 techs in biopharma manufacturing, quality control and training excellence: integrated with core operating processes to enable proof-of-concept use cases on new innovations and new ways of working, situated in a Good Manufacturing Practice (GMP) simulated environment.
Situated in NIBRT’s Dublin facility, technologies showcased include AI, dynamic scheduling and augmented reality to revolutionize manufacturing operations.
The implementation of such technologies in the biopharma industry could lead to productivity improvements of up to 40%, especially when combined with Lean methodologies.
That idea of collaboration is central to how the NIBRT approaches its work in research and in training.
“Different ideas need to be exchanged for the bettering of the whole industry: rather than just one or two companies,” says Noor.
Regulators are not the enemy
Another change towards a collaborative mindset needs to be how the industry works with regulators.
As new technologies are introduced, both need to work together to see how new ideas can be successfully, safely and properly integrated into biomanufacturing.
“I always say: you have to think of regulators as your partners, they are not there to block you doing things, at the end of the day we all have a shared vision of making sure medicines are safe and effective,” said Noor.
“So it’s really important to talk about new technologies with your regulators and understand what are their problems – do they have concerns with what you’re trying to do – and making sure the pipeline is fit for the manufacturing facilities and vice versa.”
Noor will be speaking at BioPharma-Reporter's Bioprocessing 4.0 webinar next week - register for FREE here!