Kaiser authors BioPhorum paper on continuous bioprocessing
Aug 8, 2023
Continuous bioprocessing control and connectivity
Cost-effective, rapid, and flexible biopharmaceutical production is an industry-wide challenge. Process intensification through continuous manufacturing has proved successful in other industries and is a promising area of investigation for researchers, vendors, and biomanufacturers.
However, business and technical barriers, both real and perceived, have hindered the widespread adoption of continuous bioprocessing.
This paper aims to align and standardize the current industry approach to controlling a continuous monoclonal antibody (mAb) bioprocess. It builds on the BioPhorum risk assessment template that defined an integrated continuous bioprocessing control strategy.
The first aim is to understand the product flow in an interconnected process. This is used to bring clarity to the continuous bioprocess end state, reduce the perceived complexity of continuous bioprocessing control strategies, and lower the implementation barrier for continuous bioprocessing. The ultimate goal is to increase access to biopharmaceuticals by reducing cost and time to market and improving product quality control.
The paper distills complex interactions between bioprocess unit operations into three basic control building blocks. It considers the implementation and control of a continuous process, which mitigates potential process risks. It also defines a control approach based on the specific requirements of a given process using a conserved approach to linking the outputs and inputs between unit operations.