Staff who understand the benefits of digital manufacturing are as important as the technology itself, according to a Novartis expert

Digitization is a hot topic for biopharma. Advocates say the ability to monitor and model manufacturing data in real-time as a major advantage in terms of product quality and consistency.

Technology is driving the shift from analog. But having staff who understand the benefits is as important according to Francisca Gouveia, a Senior Process Expert, MS&T at Novartis, who says the firm wants its digital transformation to be “driven by people not necessarily by the technology.

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“People have to understand and they have to see the value in order to realize the benefits of the digital tools. On the other hand, the strategy needs to be aligned with the business goals with the challenges and with the market needs as well.

“And in order to bring both together we have we have to have a change management process that is efficient on site to realize the benefits but also to be able to keep these strategies ongoing over time.”

The Golden batch?

Gouveia, who is based at Novartis’ Huningue, France facility – also told BPI delegates in September the concept of a “Golden Batch” approach – in which the parameters for a successful run are replicated for subsequent batches – is unrealistic given the level of variability inherent to biomanufacturing.

“It is completely unrealistic to think that just by automating or replicating this golden batch recipe we will be able to achieve these results consistently. And that’s why our digital transformation is pretty much settled on people.”

“In order to replicate the golden batch, we have to be ready to do small tweaks in the process to adapt our control strategies in the way that at the end we will get the best output possible.”

Data maturity

Having the correct technologies in place at the right time is also key to successfully adopting a digitial manufacturing strategy.

Gouveia explained that Novartis approach to digitization has been to look at variability reduction, control strategies and business value in terms of the “data management maturity” available for each step.

“Our initial efforts were, of course, focused in terms of having the technology mature and well implemented. So we worked a lot in terms of data sourcing in establishing interfaces for data visualization, and then moving with all performance and operational and performance qualification.

“So with that said, we could move forward and focus our efforts in consolidating and advancing the use of these technologies. So we started by implementing more real time monitoring, and, and then to a situation where we are really rethinking control strategies based on the technology that that we have now available.”