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Manufacture Technology and Equipment

What’s Beyond the Bioprocess Automation Starting Line?

Automation drives the production of higher quality and more consistent biologic drugs and regenerative therapies at reduced costs of goods (CoGS) – and with higher flexibility and faster time to market (1, 2). And when it comes to automation of bioprocesses, process analytical technology (PAT) and advanced data analytics are crucial enablers because of the need to measure critical process parameters at all stages.
 
The main advantages of bioprocess automation can be summarized as:

  • Consistency in product quality and quantity; variations of critical process parameters (CPPs) are reduced and process robustness is increased (see Figure 1).
  • Fast and predictive up- and down-scaling; a well characterized and monitored process alongside scalable hardware significantly reduces the cost and effort of scaling, as variations can be accounted for in an automated and predictive fashion.
  • Reduced risk of lost batches and increased process safety; operator errors and contamination through manual sampling are reduced. The timely identification and correction of process irregularities reduces the risk of lost batches.
  • Operators are free to work on tasks that cannot be (easily) automated.
  • Cell variation arising from different sources – as could be expected from different patients in personalized medicine – can be managed through a process that is flexible and able to dynamically adjust to wide variations – through PAT – to assure high process consistency irrespective of the starting material.

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About the Authors

Svea Grieb

Dr Svea Grieb is product manager for Process Analytical Technology (PAT) for upstream processes at Sartorius Stedim Biotech.


Kai Touw

Kai Touw is (Bio)Pharma Market Manager at Sartorius Stedim Data Analytics.


Dan Kopec

Dan Kopec is a PAT Technology Expert for Sartorius Stedim Biotech, covering the North American region.

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