Biological Process Analytical Technology (BioPAT®)

Biopharmaceutical production is highly regulated to ensure patient safety and requires appropriate process control, process validation and product characterization. However, raw material variability, the biological production system as such and the robustness of individual process steps will influence product quality. Therefore, the industry and regulatory agencies have put in place a framework for process analytical technologies and quality by design to enable better process understanding and control to improve process robustness, product quality and hence patient safety.

How BioPAT® Helped Others with

Cost Savings

Lowering the costs of process development and manufacturing without compromising quality performance is a desirable state.

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Risk Mitigation

Deviating into a process unknown during the production of biologics is a big risk.

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Capacity Adaption

Scaling up, down or transferring a process presents challenges due to the independent and linked factors which alter with a process adaptation.

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BioPAT® Toolbox

BioPAT® is much more than just one sensor plugged into a process control system.

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