BioPAT® Toolbox

BioPAT® toolbox combines analytics & software with bioprocessing unit operations from Sartorius Stedim Biotech to give you the current status, level of understanding and precise control of your process. Because they are configured out of the box solutions from us they are certified and tested products which come fully integrated. This gives you a bioprocess unit operations offering, ready-to-use, "plug and play" control basis from a single user interface with no hassle. These systems are managed and serviced from our own service department with no possibility of conflicts of interest or responsibility disputes.

Analytics and Sensors for Uni-|Multi-variate Data Gathering

Process analyzers are indispensable tools within the BioPAT® framework as they generate the front end data on Critical Processing Parameters (CPP). Depending on the level of parameter precision and the speed of its change, rapid intervention is essential to keep the process parameters within defined specifications. Dedicated inline and online analyzers provide real-time data for outstanding process control, which results in improved production quality and reduced deviation risk. Multiplexed and off-line sampling analytics aims to monitor and determine if a process is within a defined process trajectory or the product meets specification. This creates two zones (control and monitoring) depending on the rate of parameter change and level of parameter criticality.

Software for Understanding, Visualizing and Control

Design of Experiments aims to quantitatively screen critical process parameters (CPPs) to either a critical quality attribute (CQA) or a process performance indicator (PPI). Obtaining this knowledge from analytical systems that monitor the process in real-time, a series of experiments can be performed to map and select a commercially optimized processes.

Visualizing huge data sets from multiple analytical devices especially in combination with spectroscopic data, requires techniques such as Principal Component Analysis or Partial Least Square Regression. These are powerful tools to identify dominant patterns in the data, such as groups, outliers or trends. MVDA puts multi-factorial relationships into a scientific context and increases process understanding.

A consistent process requires sophisticated control of CPPs based on reliable data acquisition, evaluation and system actuation. State-of-the-art BioPAT® process control software prevents or mitigates the risk of producing batch deviations and represents a further step towards knowledge- and risk-based production of biopharmaceutical products.

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