Janssen Biologics, manufacturer of medicines and vaccines, aims to use the principle of a 'predictive plant' around 2030. How exactly does the pharmaceutical company approach this from a Quality Control perspective? Brigitta Witte, Senior Automation Supervisor at Janssen Biologics Quality Control, will talk about this during the LabAutomation event on March 21.

 By: Dimitri Reijerman

Brigitta Witte Brigitta Witte

A predictive plant comes from the concept of industry 4.0 and contains several automation elements, says Witte: “A predictive plant is automated end-to-end, from the arrival of the goods to the delivery of the products. But also that you can accurately predict what the market needs. We make these predictions based on the available data models. Furthermore, we can predict not only the required production, but also the required equipment.”

Digital twins are one of the components of the predictive plant concept. These digital twins are also used at Janssen Biologics. Witte: “We have set up a digital twin of our laboratories. Our model contains all laboratory equipment and data from our LIMS system. With this digital twin we can model the impact if, for example, extra batches of a certain product arrive at the lab. Do we have sufficient capacity or do we need new equipment? But we can also see the effect on capacity if a device fails. Ultimately, we can model various scenarios at Janssen with a digital twin.”

Robotization also plays a role. For example, to process assays: “We have a number of liquid handlers for a number of our assays,” says Witte. “These are currently used to ensure that analysts do not have to pipette all of the routine assays themselves with many incubation steps, but rather that the machines make the sample dilutions and pipet the samples onto the plates. What we want to do is for them to become more integrated systems. Our development department is working with us on this.”

End of paper?
The step towards a paperless working environment in Janssen's labs is also part of the program to create a predictive plant, says Witte: “Our labs have four specialized test teams. One of these teams started testing a paperless lab as a pilot in 2019. They are now virtually paperless, except for a number of actions that are only performed once a year. Almost all data is now entered directly into the LIMS system. The other teams are now being added to this method.”

Something that should not be forgotten is proper staff training. Because people on the work floor will remain necessary, even in the lab of the future. Witte: “There is still a lot to be achieved in the field of training in QC environments. The technology is already there, such as artificial intelligence and virtual reality, that can help employees get their assays right the first time. I also think that the enormous amount of data that a lab generates can be better used to make the right decisions in an organization.”

All in all, Janssen is taking several automation steps to achieve his final goal in about 7 years. Witte is also optimistic about the progress: “My main message is that you also have an influence on the automation of a lab in a GMP environment. So you can certainly form a 'driving force' and influence other teams. So it does not always have to be imposed by other departments. Because many QC organizations are quite conservative. Yet there is still a lot of profit to be made. A lot is possible, especially if you have the right people within the organization. I also hope to inspire people with my story about how they can tackle far-reaching automation in the lab.”

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