CODOBIO · Continuous Downstream Processing of Bioproducts

Continuous Downstream Processing of Bioproducts

A manufacturing process for biological material consists of the actual production of the product (upstream processing) and product purification (downstream processing - DSP), aiming at releasing a highly pure product. The DSP usually consists of a series of consecutive steps and is mostly done in a batch-wise manner with minimal digitalization or automation. Real-time in-process control is limited and product quality or quantity are not analysed during the production. In the last decade the regulatory framework for manufacturing of biopharmaceuticals has provided guidelines that process development needs to take into account product quality already during production. A transition to continuous processes has the prospect of better economics and reduced environmental footprint and is highly recommended by authorities but currently only a small fraction of bioproducts is produced in continuous mode. A reason for the delay in implementation of fully continuous processes is the lack of experience with such new technologies and also the lack of skilled personnel able to develop and apply continuous processes In recent years, the transition to continuous manufacturing has been recognized as the next step in further optimizing production processes in the bioindustry. Continuous manufacturing offers new opportunities to increase productivity, reduce environmental impact, improve product quality and consistency, and dramatically reduce manufacturing costs, making biologics accessible to a much wider population, including those in non-privileged countries. The significant reduction in the space required for the process will allow the manufacturing process to be carried out in a very small space, e.g. in a container, which can be transported to any location in the world and enable production of sophisticated biologics also in less-privileged countries. Continuous biomanufacturing is considered as a key enabler to arrive at a carbon neutral industry sector: it offers the possibility to enormously save resources such as water and energy and to reduce generation of waste. The main objective of the CODOBIO project is to deliver creative, entrepreneurial, highly-skilled and innovative Early Stage Researchers (ESR) that are able to face the future transition challenges and to greatly contribute to the knowledge-based economy and digitized environment in manufacturing and society in general. In the proposed research programme, the most urgent questions in continuous DSP have been addressed: - Process control and modelling of continuous DSP - Miniaturization, scale-up and scale-down of continuous DSP - Process design and development of integrated continuous DSP From the results obtained by the CODOBIO consortium we conclude: - that it is possible to scale down biomanufacturing processes by microfluidics and obtain relevant information with less material consumption - that it is possible to define batches/lots based on mathematical models. - that it is possible to establish a real continuous DSP with a non-interrupted product flow

Data: CORDIS, © European Union