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.
Moving beyond batch operation, linking process steps together and interdependence between the two require new and more complicated control strategies, and is one of the business and technical barriers that have hindered the widespread adoption of continuous bioprocessing.
This means industry urgently needs to rationalize and simplify the product handoff between unit operations – and that is why we have published Continuous bioprocessing control and connectivity.
Our paper reduces the product handoff between one unit operation and the next to just three possible control schemes, which considerably simplifies the description of connections between process steps.
“While continuous biopharmaceutical manufacturing meets the pressing need for cost-effective, responsive manufacturing solutions that adapt to fluctuating market demand, implementation is often hindered by the perceived complexity of the operations,” said Ashley Reeder, Investigator at GSK. “By distilling the control scheme down to its fundamental components, this paper provides a tangible guide for teams seeking to design and implement continuous manufacturing environments.”
Simplicity is key
Starting with an example mAb platform process, we identified 22 discrete connections, which were rationalized to 16 possible combinations based on the nature of the volumetric mass flow out of a unit operation and the volumetric mass flow into the subsequent operation. With just three control schemes relevant for the interconnection of process steps, interconnections can become conceptually and physically modular.
This is important as it drives simplicity in building the process and creates the possibility of having a standard set of valving, surge tanks, and process analytical technology employed for each control scheme. This simplifies the number of skids that must be ordered and may help reduce the inventory required to handle deviations or process failures. Also, using the same interconnection strategy between multiple operations simplifies the control strategy, as the same one can be used between all connections that use the same scheme.
Kristina Pleitt, Senior Manager at Thermo Fisher Scientific, said, “Although operationally beneficial, increasing automation and eliminating downtime between unit operations can feel like a risky, complicated aspect of continuous bioprocessing (especially for those more removed from development and implementation). Here we show how focusing on a few fundamentals and following a simple, systematic exercise makes the process control concept and strategy approachable to even those who are newer to integrated, continuous bioprocessing.”
If you are a bioprocess engineer, work in process control, or are an automation engineer who designs and implements continuous processes for manufacturing biotherapeutic molecules, then this paper is for you. It will also be useful for technical leaders in biomanufacturing and contract organizations considering implementing continuous processing capabilities.
For more information, download the paper below and contact Graeme Moody, Program Manager, at graeme.moody@biophorum.com
Abstract
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. It distils 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.
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