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Jungbauer, Alois (author), Satzer, Peter (author), Duerauer, Astrid (author), Azevedo, Ana (author), Aires-Barros, Raquel (author), Nilsson, Bernt (author), Farid, Suzy (author), Goldrick, Stephen (author), Ottens, M. (author)The main objectives of bioprocesses are to reliably deliver drugs in a relatively short time frame with high quality within a tight regulatory framework. Bioprocesses are highly complex, the level of automation is moderate, and there is constant pressure to improve efficiency and costs. In addition, climate change and resource scarcity...review 2024
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Picanço Castanheira Da Silva, T. (author), Eppink, M.H.M. (author), Ottens, M. (author)The monoclonal antibody (mAb) industry is becoming increasingly digitalized. Digital twins are becoming increasingly important to test or validate processes before manufacturing. High-Throughput Process Development (HTPD) has been progressively used as a tool for process development and innovation. The combination of High-Throughput Screening...journal article 2024
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Neijenhuis, T. (author), Le Bussy, Olivier (author), Geldhof, Geoffroy (author), Klijn, M.E. (author), Ottens, M. (author)Protein-based biopharmaceuticals require high purity before final formulation to ensure product safety, making process development time consuming. Implementation of computational approaches at the initial stages of process development offers a significant reduction in development efforts. By preselecting process conditions, experimental...journal article 2024
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Rizki, Z. (author), Ottens, M. (author)Membrane technology is commonly used within food, bio- and pharmaceutical processes. Beside single-stage membranes, multi-stage membrane systems are become more popular to improve separation performance. In this review, we present a unified four-phase model-based optimization framework to optimize these systems, using mechanistic models,...review 2023
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Rosado-Ramos, Rita (author), Poças, Gonçalo M. (author), Marques, Daniela (author), Foito, Alexandre (author), M Sevillano, David (author), Lopes-da-Silva, Mafalda (author), Gonçalves, Luís G. (author), Menezes, Regina (author), Ottens, M. (author)Parkinson's Disease (PD) is a common neurodegenerative disorder affecting millions of people worldwide for which there are only symptomatic therapies. Small molecules able to target key pathological processes in PD have emerged as interesting options for modifying disease progression. We have previously shown that a (poly)phenol-enriched...journal article 2023
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Disela, R.C. (author), Bussy, Olivier Le (author), Geldhof, Geoffroy (author), Pabst, Martin (author), Ottens, M. (author)Mass-spectrometry-based proteomics is increasingly employed to monitor purification processes or to detect critical host cell proteins in the final drug substance. This approach is inherently unbiased and can be used to identify individual host cell proteins without prior knowledge. In process development for the purification of new...journal article 2023
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Nijssen, Tim M.J. (author), Padding, J.T. (author), Ottens, M. (author)The hydrodynamics of the Expanded Bed Adsorption process is studied through simulations combining Computational Fluid Dynamics and the Discrete Element Method. A representative base case is defined, based on process design parameters commonly encountered in literature. Then, 19 other cases are defined, each representing a singular adjustment...journal article 2023
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Neves Sao Pedro, M. (author), Isaksson, Madelène (author), Gomis-Fons, Joaquín (author), Eppink, Michel H.M. (author), Nilsson, Bernt (author), Ottens, M. (author)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...journal article 2023
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Keulen, D. (author), van der Hagen, Erik (author), Geldhof, Geoffroy (author), Le Bussy, Olivier (author), Pabst, Martin (author), Ottens, M. (author)An optimal purification process for biopharmaceutical products is important to meet strict safety regulations, and for economic benefits. To find the global optimum, it is desirable to screen the overall design space. Advanced model-based approaches enable to screen a broad range of the design-space, in contrast to traditional statistical or...journal article 2023
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Rizki, Z. (author), Ravesloot, Richard (author), van Beckhoven, Ruud (author), Ottens, M. (author)The ultrafiltration/diafiltration (UF/DF) process is a crucial step in the canola protein isolation process from rapeseed meal. The process involves using a multi-stage membrane system to separate components of the mixture. As diafiltration dilutes the feed stream in the ultrafiltration system, a large amount of diafiltration water is...journal article 2023
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Application of a fluorescent dye-based microfluidic sensor for real-time detection of mAb aggregatesNeves Sao Pedro, M. (author), Eppink, Michel H.M. (author), Ottens, M. (author)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...journal article 2023
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Nijssen, Tim M.J. (author), Ottens, M. (author), Padding, J.T. (author)Lubrication forces play a major role in the behaviour of fluid–solid systems, where they affect the collisions between particles. Current implementations of lubrication forces in unresolved simulations often suffer from shortcomings, such as neglecting parts of the physics or relying on arbitrarily defined parameters. In this short...journal article 2023
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Keulen, D. (author), Geldhof, Geoffroy (author), Bussy, Olivier Le (author), Pabst, Martin (author), Ottens, M. (author)The safety requirements for vaccines are extremely high since they are administered to healthy people. For that reason, vaccine development is time-consuming and very expensive. Reducing time-to-market is key for pharmaceutical companies, saving lives and money. Therefore the need is raised for systematic, general and efficient process...journal article 2022
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Neves Sao Pedro, M. (author), Silva dos Santos, M. (author), Eppink, Michel H.M. (author), Ottens, M. (author)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...journal article 2022
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Picanço Castanheira Da Silva, T. (author), Eppink, Michel (author), Ottens, M. (author)Biopharmaceuticals are becoming increasingly important in modern healthcare. Monoclonal antibodies (mAb) are one of the most widely used therapeutic proteins and are important for the treatment of cancer and autoimmune diseases, among others. After cell culture there are still large amounts of other impurities (e.g. host cell proteins) in...journal article 2022
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Neves Sao Pedro, M. (author), Klijn, M.E. (author), Eppink, Michel H.M. (author), Ottens, M. (author)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...review 2021
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Moreno Gonzalez, M. (author), Keulen, D. (author), Gomis-Fons, Joaquín (author), Lopez Gomez, M.G. (author), Nilsson, Bernt (author), Ottens, M. (author)Efficient recovery and utilization of valuable components from industrial food side streams is a main driver towards a circular economy. Among different available purification techniques, adsorption can effectively recover these components. However, the conventional batch mode of operation can limit its applicability in food processes due to...journal article 2021
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Picanço Castanheira Da Silva, T. (author), Eppink, Michel (author), Ottens, M. (author)Process development in the biotech industry leads to investments around hundred of millions of dollars. It is important to mitigate costs without neglecting the quality of process development. Biopharmaceutical process development is important for companies to develop new processes and be first to market, improve a pre-established process, or...review 2021
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Neves Sao Pedro, M. (author), Picanço Castanheira Da Silva, T. (author), Patil, Rohan (author), Ottens, M. (author)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...journal article 2021
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Moreno Gonzalez, M. (author), Ottens, M. (author)Food side streams contain useful compounds such as proteins, sugars, polyphenols, and amino acids that might get discarded during processing. The concentration of these components may be low (e.g., fruit side streams are mainly composed by water, around 90%, while polyphenol content in rapeseed meal is less than 3% dry weight) and therefore...review 2021