Digital bioprocessing technologies will help drug makers improve product quality, reduce manufacturing costs, and fully embrace quality-by-design (QbD), says an industry expert.

The key principle of QbD is that product quality is built into manufacturing steps from the earliest stage, rather than being determined by testing after process development is completed. The drug industry began exploring QbD in the 1980s in a bid to meet regulatory demands for “high-quality” medicines. This culminated in 2009 when the FDA introduced its first QbD guidance document and began encouraging manufacturers to use the approach.

But, while many have embraced it, developing a commercial-scale production process using QbD remains a major undertaking, according to Karlheinz Landauer, PhD, founder of Swiss consulting group, QBDC.

“QbD allows to maneuver in the design space. For this, the respective process or process step needs to be fully characterized with all process controls, set-points, etc., and the effect on the target molecule needs to be fully understood,” he explains. “Currently it is very difficult to perform all these experiments and to run all analytical test items on the target molecule. In other words, it is very expensive to develop a design space which can then be put into the Common Technical Document to support the full QbD approach.”

Digital solutions

However, the emergence of innovative methods and digital bioprocessing technologies that can capture, transmit, and model process data in real-time will likely reduce the complexity and cost of QbD-based process development, according to Landauer.

“Better understanding of the biopharmaceutical process utilizing new computer technologies could help a lot. But, what might even be more important is the need for a good technology—analytical technology—to evaluate, predict, and finally model the process. The industry needs good digital twins, and also a strategy to validate those digital twins. There are some new technologies on the horizon which might allow the full QbD approach,” he says.

And the combination of QbD and digital technologies would offer other advantages, notes Landauer.

“Digital technologies would decrease the costs for commercial manufacturing [significantly], as minor adjustments could be performed without informing the regulators,” he says, adding that international drug companies would see significant benefits. “At present, process changes have to be submitted to every country prior to implementing it. And if this product is on the market in the EU and U.S., then one would have to inform many regulators. So it is a huge burden.”

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