Miniaturization of Process Analytical Technology: from Concept to Reality

Continuous biomanufacturing is considered the future phase for the optimization of production processes in the biopharmaceutical industry. Productivity, product quality and consistency are greatly improved while production costs and environmental footprint are drastically reduced. The manufacturing of monoclonal antibodies (mAbs), an important...

Application of a fluorescent dye-based microfluidic sensor for real-time detection of mAb aggregates

The lack of process analytical technologies able to provide real-time information and process control over a biopharmaceutical process has long impaired the transition to continuous biomanufacturing. For the monoclonal antibody (mAb) production, aggregate formation is a major critical quality attribute (CQA) with several known process...

Real-time detection of mAb aggregates in an integrated downstream process

The implementation of continuous processing in the biopharmaceutical industry is hindered by the scarcity of process analytical technologies (PAT). To monitor and control a continuous process, PAT tools will be crucial to measure real-time product quality attributes such as protein aggregation. Miniaturizing these analytical techniques can...

Design of a microfluidic mixer channel: First steps into creating a fluorescent dye-based biosensor for mAb aggregate detection

A major challenge in the transition to continuous biomanufacturing is the lack of process analytical technology (PAT) tools which are able to collect real-time information on the process and elicit a response to facilitate control. One of the critical quality attributes (CQAs) of interest during monoclonal antibodies production is aggregate...

Process analytical technique (PAT) miniaturization for monoclonal antibody aggregate detection in continuous downstream processing

The transition to continuous biomanufacturing is considered the next step to reduce costs and improve process robustness in the biopharmaceutical industry, while also improving productivity and product quality. The platform production process for monoclonal antibodies (mAbs) is eligible for continuous processing to lower manufacturing costs...

White paper on high-throughput process development for integrated continuous biomanufacturing

Continuous manufacturing is an indicator of a maturing industry, as can be seen by the example of the petrochemical industry. Patent expiry promotes a price competition between manufacturing companies, and more efficient and cheaper processes are needed to achieve lower production costs. Over the last decade, continuous biomanufacturing has...