Data is revolutionizing drug manufacturing, but Biopharma 4.0 will always need expertise on the factory floor, according to Marc Funk, CEO at Lonza. The term “industry 4.0” was coined in 2011 to describe the use of data integration in manufacturing. The idea is to use real-time data generated at each process step to make the whole operation more efficient.

The car and aviation industries readily embraced the approach. Pharma was slower to warm to the idea, but demand for data-driven drug making is now growing, adds Funk. “We see an increasing number of customers approaching us to explore collaboration potential for what can be termed Industry 4.0 approaches. Although pharma has been slower than other industries to fully adopt this approach due to long development times and the regulatory implications, it has been a focus at Lonza for a number of years. As a CDMO, we generate a lot of data on different processes and products so exploring how we can best use this to provide value to customers is key.”

Digital twin

This view is shared by Hernan Vilas, head of the CMDO’s operational technology and digital strategy unit.

“Many requests focus on providing advanced data analytics that Lonza generates through our electronic batch records and data driven operations,” Vilas said, noting that “A major goal of our collaborations is to maintain high manufacturing consistency, which will enable faster batch delivery to customers.”

One such collaboration involves use of digital twin technology whereby a virtual replica of a physical bioprocessing line is used as a model to test potential changes.  Vilas explains that the project has “provided additional insights into further data that we can collect to improve our manufacturing speed. Though this pilot requires further work, the outcome is encouraging and will benefit data-driven manufacturing.”

Another project, based at Lonza’s former Capsugel site in Bend, Oregon, is using machine learning combined with QbD to better understand bioprocesses in cell culture.

“The goal is to build up an understanding of the complex processes inside the bioreactor and how they affect the product, but also to develop predictive analytics,” said Vilas. “We can then link this up with in-line monitoring and controller technology to run an optimized, automated process.”

Talent and tech

Industry 4.0 advocates often highlight automation as its major advantage. While Funk acknowledges this, he says the success of any digital manufacturing operation will ultimately always depend on human expertise.

“People will remain key although the profiles we look for when acquiring talent will evolve. For example, we will need more experts in robotics and bioinformatics. Even today when you look at a bioprocessing line, it’s usually quiet with only a few highly-qualified operators,” he says. “I don’t see technology replacing people, but it will make our business more efficient and better equipped to deliver increasingly complex medicines at the highest quality.”

Personalized manufacturing

Rare diseases and personalized medicine are a growing area of interest for the pharmaceutical industry. Medicines for small patient populations can command high prices and are less likely to face competition from generics when they lose patent protection.

The challenge, for traditional pharmaceutical manufacturers, is making low volume products in an economic manner. Digital manufacturing could help, according to Funk, particularly if they move the industry away from its reliance on large, costly production sites.

Digital technologies could enable decentralized manufacturing in other areas and may even drastically change the current supply chain,” he points out. For example, in the cell and gene therapy space, we’re currently evaluating a ‘cGMP in a box’ system for autologous cell therapy manufacturing, called Cocoon.  This system can be tailored to a specific process and could even be used at point of care to produce several different products whilst maintaining data security for patients and sponsors.”

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