Process Analytical Technology (PAT)

Process Analytical Technology (PAT) is a term used to describe any system that enables control over pharmaceutical manufacturing processes with the goal of ensuring final product quality. The timely measurement (i.e. during processing) of critical quality and performance attributes of raw and in-process materials is essential when implementing PAT.

PAT can be easy. You just need smart solutions.

The utilization of PAT in complex biopharmaceutical processes is critical for maintaining product quality across a wide range of manufacturing scales despite the heterogeneous nature of living cells. However, PAT can be challenging to implement due to contamination concerns with off-line measurements, limited sample, poor sensitivity, time constraints, etc. On-line monitoring of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and Key Performance Indicators (KPIs) in real time resolves these issues by facilitating improvements in process control, root cause analysis, and process characterization.

Ongoing trends currently faced by this industry emphasize the importance of these measurements.

  • The emergence of continuous processing
  • The move towards single-use technologies
  • The focus on improved process productivity

Ovizio is a leading provider of label-free solutions for the on-line, continuous monitoring of cell-based CQAs such as viability assessment, Total Cell Density (TCD), Viable Cell Density (VCD), and aggregation rates.

The GMP generation of the iLine F microscope, the iLine F PRO, is compliant by design (IPx3, passive cooling, CFR21) and comes with a full validation package customized for the needs of our customers that are moving to clinical trials, manufacturing and commercial operations.

To learn more about how our solutions can improve your bioprocess workflows, check out the case studies below or visit our iLine F microscope product page.

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