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.
continuous downstream processing
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Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version
A comprehensive response to ICH Continuous manufacturing of drug substances and drug products Q13 draft version. The BioPhorum team overall think the draft reads well and believes the concepts and ideas are aligned with BioPhorum thinking on continuous manufacturing for biologic drug substance and drug product.
This paper gives an overview of an accompanying risk assessment template and acts as a blueprint for industry. It will be useful for any organization new to continuous bioprocessing, while experienced companies can use it to benchmark their existing operations.The blueprint will accelerate the realization of commercial continuous biomanufacturing processes and signals to regulators that this is the direction of industry travel, with a consensus view of how it should be done.The control plan will help lower the implementation barrier for starting continuous bioprocessing and provide a better understanding of its needs for end-users and potential vendors as it aligns and standardizes the industry’s validation approach.