Article | June 11, 2019

Full Single-Use Downstream Process? Not Any Time Soon

Source: Cytiva

By Madhu Raghunathan, Product Strategy Leader at GE Healthcare Life Sciences

GE

Marrying single-use upstream and hybrid downstream simply works

Why is there a greater adoption of SUTs in upstream compared to downstream processing? One reason is the more complex clean-in-place (CIP) and sterilization-in-place (SIP) requirements in upstream. The growth environment, high processing volume, and high presence of in-process impurities increase the risk of bioburden.

As you move downstream, bioburden risk and volumes decrease. But the value of the biologic drug and the burden of demonstrating its purity increase exponentially. Consequently, sensors used to secure quality need to have great accuracy and sensitivity. However, most single-use sensors used today have limitations in this aspect.

All in all, a hybrid approach to unit operations downstream often makes good business and process sense. So, I believe that hybrid solutions are here to stay...At least until technical advances allows a full single-use downstream process.

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