Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 9 of 9
Full-Text Articles in Engineering
Ultra Scale-Down Mimics For Perfusion Culture: Experimental Study For Rapid Biopharmaceutical Process Development, Molly Tregidgo, David Pollard, Martina Micheletti
Ultra Scale-Down Mimics For Perfusion Culture: Experimental Study For Rapid Biopharmaceutical Process Development, Molly Tregidgo, David Pollard, Martina Micheletti
Integrated Continuous Biomanufacturing III
With the industry driving towards the implementation of whole continuous bioprocess sequences, there becomes a requirement for the development of scale-down tools with the same consistency, reliability and throughput as those already available for traditional batch processes. This work aims to develop a perfusion scale-down system capable of reproducing the specific characteristics of the perfusion culture process, namely cell retention capabilities, the ability to support high cell densities and to operate for extended periods compared to fed-batch cultures. Cell culture in microwell plates in fed-batch mode is well defined and is in widespread use; however to the best of our …
Fouling Mitigation In Membrane Based Perfusion Systems By Oscillating Tangential Flow, Maria Weinberger, Ulrich Kulozik
Fouling Mitigation In Membrane Based Perfusion Systems By Oscillating Tangential Flow, Maria Weinberger, Ulrich Kulozik
Integrated Continuous Biomanufacturing III
Good scalability and robust handling have promoted the application of membrane based cell retention devices. A physical barrier, i.e. a filter, retains cells and cell debris. One major drawback of these devices is their ten-dency to foul and clog. One form of fouling is deposit layer formation on the filter surface, consisting of cells, cell debris and other fermentation broth constituents. This leads to the build-up of a secondary membrane, which can alter the permeation profile. Furthermore, deposit layers lead to an increased filtration resistance and thus negatively affect permeate flux, filtration efficiency and process robustness. In tangential flow filtration, …
Bioprocess Intensification And Optimisation Using Macroscopic Predictive Models Of Cell Culture Processes, Bassem Ben Yahia, Boris Fessler, Gwendal Gränicher, An-Vy Tran, Mareike Harmsen, Elmar Heinzle
Bioprocess Intensification And Optimisation Using Macroscopic Predictive Models Of Cell Culture Processes, Bassem Ben Yahia, Boris Fessler, Gwendal Gränicher, An-Vy Tran, Mareike Harmsen, Elmar Heinzle
Integrated Continuous Biomanufacturing III
Chinese Ovary Hamster (CHO) are an indispensable tool for biotechnological production of biologics which is a multi-million business. Recently, the pharmaceutical industry is increasingly focusing in the use of perfusion mode. Nevertheless, the optimal perfusion rate during biopharmaceutical perfusion production is dependent on cell metabolism which can be characterized by mathematical models. This study provides insights into the predictive capacities of systematic and simple cell modeling approaches of metabolism, growth and production of monoclonal antibodies (mAb) [1] to optimized medium composition and perfusion rate during CHO perfusion culture. We applied the metabolic steady state concept and used a segmented linear …
Up And Down Scale Considerations For The Continuous Production Of Glycooptimized Biopharmaceuticals, Steffen Kreye, Rainer Stahn
Up And Down Scale Considerations For The Continuous Production Of Glycooptimized Biopharmaceuticals, Steffen Kreye, Rainer Stahn
Integrated Continuous Biomanufacturing III
Product quality especially with respect to glycosylation is a critical product attribute which can have an immense influence on the activity of glycoproteins and should be closely monitored during process development and manufacturing. GlycoExpressTM cells have been developed in this context to provide human host cell lines with robust glycosylation machineries. This work will address challenges in two case studies for up and down scaling of production processes with focus on product quality and continuous processing. In a first section, data of a process transfer from a 200 L stainless steel to a 1000 L single-use bioreactor for a continuous …
Up And Down Scale Considerations For The Continuous Production Of Glycooptimized Biopharmaceuticals, Steffen Kreye, Rainer Stahn
Up And Down Scale Considerations For The Continuous Production Of Glycooptimized Biopharmaceuticals, Steffen Kreye, Rainer Stahn
Integrated Continuous Biomanufacturing III
Product quality especially with respect to glycosylation is a critical product attribute which can have an immense influence on the activity of glycoproteins and should be closely monitored during process development and manufacturing. GlycoExpressTM cells have been developed in this context to provide human host cell lines with robust glycosylation machineries. This work will address challenges in two case studies for up and down scaling of production processes with focus on product quality and continuous processing. In a first section, data of a process transfer from a 200 L stainless steel to a 1000 L single-use bioreactor for a continuous …
Fouling Mitigation In Membrane Based Perfusion Systems By Oscillating Tangential Flow, Maria Weinberger, Ulrich Kulozik
Fouling Mitigation In Membrane Based Perfusion Systems By Oscillating Tangential Flow, Maria Weinberger, Ulrich Kulozik
Integrated Continuous Biomanufacturing III
Good scalability and robust handling have promoted the application of membrane based cell retention devices. A physical barrier, i.e. a filter, retains cells and cell debris. One major drawback of these devices is their ten-dency to foul and clog. One form of fouling is deposit layer formation on the filter surface, consisting of cells, cell debris and other fermentation broth constituents. This leads to the build-up of a secondary membrane, which can alter the permeation profile. Furthermore, deposit layers lead to an increased filtration resistance and thus negatively affect permeate flux, filtration efficiency and process robustness. In tangential flow filtration, …
Ultra Scale-Down Mimics For Perfusion Culture: Experimental Study For Rapid Biopharmaceutical Process Development, Molly Tregidgo, Martina Micheletti, David Pollard
Ultra Scale-Down Mimics For Perfusion Culture: Experimental Study For Rapid Biopharmaceutical Process Development, Molly Tregidgo, Martina Micheletti, David Pollard
Integrated Continuous Biomanufacturing III
With the industry driving towards the implementation of whole continuous bioprocess sequences, there becomes a requirement for the development of scale-down tools with the same consistency, reliability and throughput as those already available for traditional batch processes. This work aims to develop a perfusion scale-down system capable of reproducing the specific characteristics of the perfusion culture process, namely cell retention capabilities, the ability to support high cell densities and to operate for extended periods compared to fed-batch cultures. Cell culture in microwell plates in fed-batch mode is well defined and is in widespread use; however to the best of our …
Optimizing Media For Perfusion Combining Predictive Scale-Down Models And Multivariate Approaches, Jochen Sieck, Christian Schultheiss, Pedro Felizardo
Optimizing Media For Perfusion Combining Predictive Scale-Down Models And Multivariate Approaches, Jochen Sieck, Christian Schultheiss, Pedro Felizardo
Integrated Continuous Biomanufacturing III
Perfusion medium development is complex and time-consuming. Thus, a methodology for efficient and cost effective development leading to a significant reduction of time to market is key in today's competitive market. Success in perfusion medium development depends strongly on the choice of optimization tools. Here a streamlined strategic approach to accentuate perfusion media development is presented by means of predictive scale down models and the application of Design of Experiments (DOE). The purpose of the study was to investigate the impact of 19 amino acids on productivity and growth of a CHO-K1 cell line in perfusion cell culture. A stepwise …
Bioprocess Intensification And Optimisation Using Macroscopic Predictive Models Of Cell Culture Processes, Bassem Ben Yahia, Mareike Harmsen, An-Vy Tran, Gwendal Gränicher, Boris Fessler, Elmar Heinzle
Bioprocess Intensification And Optimisation Using Macroscopic Predictive Models Of Cell Culture Processes, Bassem Ben Yahia, Mareike Harmsen, An-Vy Tran, Gwendal Gränicher, Boris Fessler, Elmar Heinzle
Integrated Continuous Biomanufacturing III
CHO cells, modeling, perfusion, ATF, segmented linear model