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Records with Keyword: Process Intensification
Showing records 26 to 50 of 56. [First] Page: 1 2 3 Last
Concept of an Enzymatic Reactive Extraction Centrifuge
Francesca Meyer, Nijat Gasimov, Paul Bubenheim, Thomas Waluga
February 23, 2023 (v1)
Subject: Materials
Keywords: biocatalysis, hybrid process, multi-enzyme cascade, process integration, Process Intensification
Biocatalytic processes often provide an ecological alternative to many chemical processes. However, further improvements in terms of the economic efficiency are required. In order to achieve that, the concept of process integration is a promising option. Applying this within a biocatalytic process, a highly integrated apparatus working as a reactive extraction centrifuge was developed and operated. For this purpose, a commercially available extraction centrifuge was modified to implement a biocatalytic reaction. The novel apparatus was used within a multi-enzyme cascade for the production of a natural flavor and fragrance, namely cinnamic ester. The characterization of the reactive extraction centrifuge and the suitable operation conditions for the inlet streams and the rotational speed for a stable operation were determined. Furthermore, different initial substrate concentrations were applied to prove the reaction. The results provide a successful proof of concept for the novel reacti... [more]
In Silico CFD Investigation of the Granulation Hydrodynamics in Rotating Drum: Process Sensitivity to the Operating Parameters and Drag Models
Safae Elmisaoui, Saad Benjelloun, Radouan Boukharfane, Lhachmi Khamar, Sanae Elmisaoui, Mohamed Khamar
February 23, 2023 (v1)
Keywords: Euler–Euler approach, granulation, kinetic theory of granular flow, Process Intensification, process optimization
Computational fluid dynamics (CFD) have been extensively used to simulate the hydrodynamics of multiphase flows (MPFs) in rotating machinery. In the presence of a granular dense phase, the Kinetic Theory of Granular Flow (KTGF) is usually coupled to Eulerian multi-fluid models to obtain tractable computational fluid models. In the present work, the hydrodynamic behavior of a three dimensional, industrial scale, and rotating drum granulator with gas−solid flows is assessed using the Eulerian−Eulerian approach coupled with the k-ε standard turbulence model. A Eulerian−Eulerian Two-Fluid Model (TFM) is used with the KTGF model for the granular phase. The sensitivities to different operating parameters, including the rotational speed (8, 16, and 24 rpm), inclination degree (3.57∘, 5.57∘, and 7.57∘), and degree of filling (20%, 30%, and 40%) are studied. Moreover, the impact of the drag model on the simulation accuracy is investigated. The flow behavior, regime transitions, and particle dis... [more]
Process Intensification in Photocatalytic Decomposition of Formic Acid over a TiO2 Catalyst by Forced Periodic Modulation of Concentration, Temperature, Flowrate and Light Intensity
Thomas Ellwood, Luka A. Živković, Petr Denissenko, Rufat Sh. Abiev, Evgeny V. Rebrov, Menka Petkovska
February 23, 2023 (v1)
Keywords: forced periodic modulation, formic acid decomposition, non-stationary CSTR, Process Intensification, TiO2
The effect of forced periodic modulation of several input parameters on the rate of photocatalytic decomposition of formic acid over a TiO2 thin film catalyst has been investigated in a continuously stirred tank reactor. The kinetic model was adopted based on the literature and it includes acid adsorption, desorption steps, the formation of photocatalytic active sites and decomposition of the adsorbed species over the active titania sites. A reactor model was developed that describes mass balances of reactive species. The analysis of the reactor was performed with a computer-aided nonlinear frequency response method. Initially, the effect of amplitude and frequency of four input parameters (flowrate, acid concentration, temperature and light intensity) were studied. All single inputs provided only a minor improvement, which did not exceed 4%. However, a modulation of two input parameters, inlet flowrate and the acid molar fraction, considerably improved the acid conversion from 80 to 9... [more]
Effect of Different Configurations on Bubble Cutting and Process Intensification in a Micro-Structured Jet Bubble Column Using Digital Image Analysis
Guanghui Chen, Zhongcheng Zhang, Fei Gao, Jianlong Li, Jipeng Dong
February 22, 2023 (v1)
Keywords: bubble cutting, bubble size distribution, chemical reaction engineering, mass transfer, micro-structured jet bubble column, Process Intensification
An experimental study was conducted in this work to investigate the effect of different configurations on bubble cutting and process intensification in a micro-structured jet bubble column (MSJBC). Hydrodynamic parameters, including bubble size, flow field, liquid velocity, gas holdup as well as the interfacial area, were compared and researched for a MSJBC with and without mesh. The bubble dynamics and cutting images were recorded by a non-invasive optical measurement. An advanced particle image velocimetry technique (digital image analysis) was used to investigate the influence of different configurations on the surrounding flow field and liquid velocity. When there was a single mesh and two stages of mesh compared with no mesh, the experimental results showed that the bubble size decreased by 22.7% and 29.7%, the gas holdup increased by 5.7% and 9.7%, and the interfacial area increased by more than 34.8% and 43.5%, respectively. Significant changes in the flow field distribution cau... [more]
Novel Module-Based Design Algorithm for Intensified Membrane Reactor Systems
Brent A. Bishop, Fernando V. Lima
February 22, 2023 (v1)
Keywords: membrane reactors, module-based design, Process Intensification
The growing interest in intensified process units that improve efficiency by combining several phenomena into one unit, has led to a loss in degrees of freedom when addressing the control scheme of these units. Previous work demonstrated that a novel module-based design approach to membrane reactors could improve the operability index of membrane reactor systems. This approach sought to decouple the phenomena to regain some degrees of freedom for the control system. However, the computational time to determine such an optimal module design made this class of design problems intractable to solve in a reasonable amount of time. This work proposes a set of design heuristics for a new module-based design approach for membrane reactors. These heuristics are used in combination with a genetic algorithm formulation to produce a novel, two-staged algorithm for the design and control of membrane reactor systems. This algorithm is developed in Python and uses rigorous membrane reactor models bui... [more]
Advancements in Optimization and Control Techniques for Intensifying Processes
Jesús Rafael Alcántara Avila, Zong Yang Kong, Hao-Yeh Lee, Jaka Sunarso
February 22, 2023 (v1)
Process Intensification (PI) is a vast and growing area in Chemical Engineering, which deals with the enhancement of current technology to enable improved efficiency; energy, cost, and environmental impact reduction; small size; and better integration with the other equipment. Since process intensification results in novel, but complex, systems, it is necessary to rely on optimization and control techniques that can cope with such new processes. Therefore, this review presents some advancements in the field of process intensification that are worthy of exploring in detail in the coming years. At the end, several important open questions that can be taken into consideration in the coming years are listed.
Climate Neutrality Concepts for the German Chemical−Pharmaceutical Industry
Axel Schmidt, Dirk Köster, Jochen Strube
February 21, 2023 (v1)
Subject: Environment
Keywords: circular economy, climate neutrality, cost of goods, digitalization, global warming potential, green technology, power-to-X, Process Intensification, Renewable and Sustainable Energy, section coupling
This paper intends to propose options for climate neutrality concepts by taking non-German international experiences and decisions made into account. Asia-Pacific and Arabic countries do have already same lessons learned by large-scale projects with regard to economic evaluations. Quite a few conceptual studies to generate the climate neutrality of the chemical−pharmaceutical industry in Germany have been published recently. Most of the studies differ even in magnitude but do not refer to or evaluate the other ones. These are all first theoretical feasibility studies. Experimental piloting is not far developed; only few and only stand-alone parts are operated, with no overall concepts. Economic evaluation is missing nearly completely. Economic analysis shows a factor 3 more expensive green technologies. Even if a large optimization potential of about 30% during manufacturing optimization is assumed as significant, cost increases would result. To make green products nevertheless competi... [more]
Development of Concepts for a Climate-Neutral Chemical−Pharmaceutical Industry in 2045
Alexander Uhl, Axel Schmidt, Christoph Jensch, Dirk Köster, Jochen Strube
February 21, 2023 (v1)
Subject: Environment
Keywords: circular economy, climate neutrality, global warming potential, green technology, power-to-X, Process Intensification, Renewable and Sustainable Energy, section coupling
Global primary energy consumption has increased tenfold over the course of the 20th Century, the availability of non-renewable energy is becoming scarce, and the burning of fossil fuels is leading to global warming. Climate change has now become tangible. The will to act against fossil fuels has become apparent in the western world, and in Germany in particular. This poses a particular challenge for the chemical and pharmaceutical industry, since, in the future, not only will the energy input, but also the feedstock, have to come from non-fossil sources. They must be replaced by carbon capture and utilization, and the exploitation of a circular economy. Concepts for a climate-neutral chemical−pharmaceutical industry have been developed and evaluated. Due to a high predicted consumption of renewable energies and an insufficient expansion of these, Germany will remain an energy importer in the future. The largest consumer in a climate-neutral chemical−pharmaceutical industry will be elec... [more]
Scale-Up Strategies of Jet Loop Reactors for the Intensification of Mass Transfer Limited Reactions
Marc Maly, Steffen Schaper, Rafael Kuwertz, Marko Hoffmann, Joachim Heck, Michael Schlüter
February 21, 2023 (v1)
Subject: Materials
Keywords: chemical reactors, mass transfer, multiphase flows, Process Intensification, reactor concepts, scale-up strategies
For the purpose of the intensification of an industrial-scale gas-liquid process, the implementation in an alternative reactor concept is investigated at Hamburg University of Technology (TUHH) in cooperation with Ehrfeld Mikrotechnik GmbH. Existing process operation data from a bubble column hint at a mass transfer limitation of the gas-liquid reaction. In the project, a jet loop reactor (JLR) is chosen to increase the specific interfacial area between gas and liquid, and thus increase mass transfer, while keeping the reactor system mechanically simple and low-maintenance. For the investigation, a laboratory scale reactor has been designed on the basis of an existing industrial scale process and scaled according to a pilot scale reactor available at TUHH. For scaling, geometric similarity is desired, while specific energy dissipation rate and volumetric gas input are kept constant for the chosen scale-up strategy. Between the two different scales, the reactors are successfully charact... [more]
Valorization of Cereal Byproducts with Supercritical Technology: The Case of Corn
Ádina L. Santana, Maria Angela A. Meireles
February 21, 2023 (v1)
Subject: Biosystems
Keywords: biorefinery, biowaste, cost of manufacture, Process Intensification, supercritical CO2, yellow corn
Ethanol and starch are the main products generated after the processing of corn via dry grinding and wet milling, respectively. Milling generates byproducts including stover, condensed distillers’ solubles, gluten meal, and the dried distillers’ grains with solubles (DDGS), which are sources of valuable compounds for industry including lignin, oil, protein, carotenoids, and phenolic compounds. This manuscript reviews the current research scenario on the valorization of corn milling byproducts with supercritical technology, as well as the processing strategies and the challenges of reaching economic feasibility. The main products recently studied were biodiesel, biogas, microcapsules, and extracts of enriched nutrients. The pretreatment of solid byproducts for further hydrolysis to produce sugar oligomers and bioactive peptides is another recent strategy offered by supercritical technology to process corn milling byproducts. The patents invented to transform corn milling byproducts incl... [more]
Optimization of the Production of 1,1-Diethoxybutane by Simulated Moving Bed Reactor
Jasper Spitters, Jonathan C. Gonçalves, Rui P. V. Faria, Alírio E. Rodrigues
October 12, 2022 (v1)
Subject: Optimization
Keywords: 1,1-diethoxybutane, Adsorption, heterogeneous catalysts, Process Intensification, simulated moving bed reactor
Simulated moving bed technology is applied in the field of pharmaceutical, petrochemical and fine chemistry. It shows capability in separating multicomponent mixtures up to high purities. In this work, an attempt was made to optimize the production of 1,1-diethoxybutane (DEB), using the simulated moving bed technology. A fixed bed model is made with good agreement with experimental results. This fixed bed model was expanded to a simulated moving bed model. This model was used to determine the optimum conditions regarding the switching time and flowrates in each section. From this model, the optimum switching time was found to be 2.4 min, and the ratio of liquid flowrate over the solid flowrate in Section 1Section 2Section 3 and Section 4 of the SMBR was found to be 4.24, 1.77, 3.03 and 1.35, respectively. Under those conditions, the productivity was 19.8 kg DEB per liter of adsorbent per day, and the desorbent consumption was 6.1 L of ethanol per kg of DEB. The results were obtained wi... [more]
Shear-Thinning Effect of the Spinning Disc Mixer on Starch Nanoparticle Precipitation
Sahr Sana, Vladimir Zivkovic, Kamelia Boodhoo
July 19, 2021 (v1)
Subject: Materials
Keywords: Process Intensification, shear rate, solvent–antisolvent precipitation, spinning disc, starch nanoparticles, thin films
Spinning disc technology is capable of achieving intensified micromixing within thin liquid films created through large shear rates, typically of the order of 103 s−1, generated by means of fast disc surface rotation. In this study the effect of the high shear on solvent−antisolvent mixing and starch nanoparticle precipitation is reported. Rheological studies of starch solutions at 2% w/v and 4% w/v have demonstrated their shear-thinning behaviour at the large shear rates experienced on the spinning disc surface. The effect of such high shear rate on starch nanoparticle precipitation is investigated alongside solute concentration and several other operating parameters such as flow rate, disc rotational speed, and solvent/antisolvent ratio. A reduction in nanoparticle size has been observed with an increase in starch concentration, although agglomeration was found to be more prevalent amongst these smaller particles particularly at larger flow rates and disc rotational speeds. Micromixi... [more]
Enhancing the Thermal Performance of Slender Packed Beds through Internal Heat Fins
Nico Jurtz, Steffen Flaischlen, Sören C. Scherf, Matthias Kraume, Gregor D. Wehinger
June 21, 2021 (v1)
Keywords: computational fluid dynamics (CFD), Discrete Element Method (DEM), heat fins, heat transfer, packed bed reactor, pressure drop, Process Intensification
Slender packed beds are widely used in the chemical and process industry for heterogeneous catalytic reactions in tube-bundle reactors. Under safety and reaction engineering aspects, good radial heat transfer is of outstanding importance. However, because of local wall effects, the radial heat transport in the vicinity of the reactor wall is hindered. Particle-resolved computational fluid dynamics (CFD) is used to investigate the impact of internal heat fins on the near wall radial heat transport in slender packed beds filled with spherical particles. The simulation results are validated against experimental measurements in terms of particle count and pressure drop. The simulation results show that internal heat fins increase the conductive portion of the radial heat transport close to the reactor wall, leading to an overall increased thermal performance of the system. In a wide flow range (100<Rep<1000), an increase of up to 35% in wall heat transfer coefficient and almost 90% i... [more]
Study on the Nonlinear Dynamics of the Continuous Stirred Tank Reactors
Liangcheng Suo, Jiamin Ren, Zemeng Zhao, Chi Zhai
May 26, 2021 (v1)
Keywords: bifurcation analysis, output multiplicity, Process Intensification, torus dynamics
Chemical processes often exhibit nonlinear dynamics and tend to generate complex state trajectories, which present challenging operational problems due to complexities such as output multiplicity, oscillation, and even chaos. For this reason, a complete knowledge of the static and dynamic nature of these behaviors is required to understand, to operate, to control, and to optimize continuous stirred tank reactors (CSTRs). Through nonlinear analysis, the possibility of output multiplicity, self-sustained oscillation, and torus dynamics are studied in this paper. Specifically, output multiplicity is investigated in a case-by-case basis, and related operation and control strategies are discussed. Bifurcation analysis to identify different dynamic behaviors of a CSTR is also implemented, where operational parameters are identified to obtain self-oscillatory dynamics and possible unsteady-state operation strategy through designing the CSTR as self-sustained periodic. Finally, a discussion on... [more]
Rapid Multi-Objective Optimization of Periodically Operated Processes Based on the Computer-Aided Nonlinear Frequency Response Method
Luka A. Živković, Viktor Milić, Tanja Vidaković-Koch, Menka Petkovska
May 17, 2021 (v1)
Keywords: computer-aided nonlinear frequency response, cost–benefit indicator analysis, dynamic multi-objective optimization, forced periodic regime, Process Intensification
The dynamic optimization of promising forced periodic processes has always been limited by time-consuming and expensive numerical calculations. The Nonlinear Frequency Response (NFR) method removes these limitations by providing excellent estimates of any process performance criteria of interest. Recently, the NFR method evolved to the computer-aided NFR method (cNFR) through a user-friendly software application for the automatic derivation of the functions necessary to estimate process improvement. By combining the cNFR method with standard multi-objective optimization (MOO) techniques, we developed a unique cNFR−MOO methodology for the optimization of periodic operations in the frequency domain. Since the objective functions are defined with entirely algebraic expressions, the dynamic optimization of forced periodic operations is extraordinarily fast. All optimization parameters, i.e., the steady-state point and the forcing parameters (frequency, amplitudes, and phase difference), ar... [more]
Computer-Aided Nonlinear Frequency Response Method for Investigating the Dynamics of Chemical Engineering Systems
Luka A. Živković, Tanja Vidaković-Koch, Menka Petkovska
May 11, 2021 (v1)
Keywords: experimental identification, frequency response functions, nonlinear process dynamics, periodic processes, Process Intensification, process systems engineering
The Nonlinear Frequency Response (NFR) method is a useful Process Systems Engineering tool for developing experimental techniques and periodic processes that exploit the system nonlinearity. The basic and most time-consuming step of the NFR method is the derivation of frequency response functions (FRFs). The computer-aided Nonlinear Frequency Response (cNFR) method, presented in this work, uses a software application for automatic derivation of the FRFs, thus making the NFR analysis much simpler, even for systems with complex dynamics. The cNFR application uses an Excel user-friendly interface for defining the model equations and variables, and MATLAB code which performs analytical derivations. As a result, the cNFR application generates MATLAB files containing the derived FRFs in a symbolic and algebraic vector form. In this paper, the software is explained in detail and illustrated through: (1) analysis of periodic operation of an isothermal continuous stirred-tank reactor with a sim... [more]
Digital Twin for Lyophilization by Process Modeling in Manufacturing of Biologics
Leon S. Klepzig, Alex Juckers, Petra Knerr, Frank Harms, Jochen Strube
April 30, 2021 (v1)
Keywords: biologics, digital twin, lyophilization, manufacturing, model validation, Process Intensification, quality-by-design
Lyophilization stabilizes formulated biologics for storage, transport and application to patients. In process design and operation it is the link between downstream processing and with final formulation to fill and finish. Recent activities in Quality by Design (QbD) have resulted in approaches by regulatory authorities and the need to include Process Analytical Technology (PAT) tools. An approach is outlined to validate a predictive physical-chemical (rigorous) lyophilization process model to act quantitatively as a digital twin in order to allow accelerated process design by modeling and to further-on develop autonomous process optimization and control towards real time release testing. Antibody manufacturing is chosen as a typical example for actual biologics needs. Literature is reviewed and the presented procedure is exemplified to quantitatively and consistently validate the physical-chemical process model with aid of an experimental statistical DOE (design of experiments) in pil... [more]
Classification and Comparison of Dividing Walls for Distillation Columns
Zewei Chen, Rakesh Agrawal
November 11, 2020 (v1)
Keywords: dividing wall column, multicomponent distillation, Process Intensification
A classification method is proposed to classify dividing walls into 5 types. Each type of dividing wall has its unique structural characteristics which impact its total vapor duty, construction complexity and controllability. Based on this classification, a comprehensive guideline to draw optimal dividing wall columns for any n-component distillation is provided.
Solution Polymerization of Acrylic Acid Initiated by Redox Couple Na-PS/Na-MBS: Kinetic Model and Transition to Continuous Process
Federico Florit, Paola Rodrigues Bassam, Alberto Cesana, Giuseppe Storti
November 9, 2020 (v1)
Keywords: free-radical polymerization, Poly(acrylic acid), Process Intensification, reaction model, semi-batch to continuous
This work aims at modeling in detail the polymerization of non-ionized acrylic acid in aqueous solution. The population balances required to evaluate the main average properties of molecular weight were solved by the method of moments. The polymerization process considered is initiated by a persulfate/metabisulfate redox couple and, in particular, the kinetic scheme considers the possible formation of mid-chain radicals and transfer reactions. The proposed model is validated using experimental data collected in a laboratory-scale discontinuous reactor. The developed kinetic model is then used to intensify the discontinuous process by shifting it to a continuous one based on a tubular reactor with intermediate feeds. One of the experimental runs is selected to show how the proposed model can be used to assess the transition from batch to continuous process and allow faster scale-up to industrial scale using a literature approach.
Phenolic Compounds Extraction of Arbutus unedo L.: Process Intensification by Microwave Pretreatment
Agostinho M. R. C. Alexandre, Ana A. Matias, Maria Rosário Bronze, Maria Jose Cocero, Rafael Mato
May 22, 2020 (v1)
Keywords: Arbutus unedo, microwave pretreatment, phenolic compounds, Process Intensification
Arbutus unedo L., commonly known as the strawberry-tree fruit, is an endemic species of the Mediterranean flora. Microwave extraction technology has been considered as a fast and “green” method for the production of extracts rich in bioactive compounds, although the energy consumption is high. To overcome this bottleneck, microwave was used as a pretreatment procedure in short time periods. This technique promotes the burst of intracellular vacuoles leading to an increase in the lixiviation of phenolic compounds. Different approaches were tested, namely a solvent-free irradiation (SFI), a solvent-assisted irradiation (SAI) and a pressurized solvent-assisted irradiation (PSAI). After irradiation, a solid−liquid extraction procedure was performed using a mixture of water and ethanol. A kinetic evaluation of the total phenolic content (TPC) was performed using the Folin−Ciocalteu method. For the total anthocyanin content, a UV-spectrophotometric method was used. HPLC-UV and LC-MS were use... [more]
Modeling, Simulation, and Operability Analysis of a Nonisothermal, Countercurrent, Polymer Membrane Reactor
Brent A. Bishop, Fernando V. Lima
February 12, 2020 (v1)
Keywords: modularity, operability, Process Intensification, process modeling and simulation
As interest in the modularization and intensification of chemical processes continues to grow, more research must be directed towards the modeling and analysis of these units. Intensified process units such as polymer membrane reactors pose unique challenges pertaining to design and operation that have not been fully addressed. In this work, a novel approach for modeling membrane reactors is developed in AVEVA’s Simcentral Simulation Platform. The produced model allows for the simulation of polymer membrane reactors under nonisothermal and countercurrent operation for the first time. This model is then applied to generate an operability mapping to study how operating points translate to overall unit performance. This work demonstrates how operability analyses can be used to identify areas of improvement in membrane reactor design, other than just using operability mapping studies to identify optimal input conditions. The performed analysis enables the quantification of the Pareto front... [more]
Plant and Biomass Extraction and Valorisation under Hydrodynamic Cavitation
Zhilin Wu, Daniele F. Ferreira, Daniele Crudo, Valentina Bosco, Livio Stevanato, Annalisa Costale, Giancarlo Cravotto
January 19, 2020 (v1)
Keywords: biomass treatment, hydrodynamic cavitation, plant extraction, Process Intensification, rotor/stator hydrodynamic rector
Hydrodynamic cavitation (HC) is a green technology that has been successfully used to intensify a number of process. The cavitation phenomenon is responsible for many effects, including improvements in mass transfer rates and effective cell-wall rupture, leading to matrix disintegration. HC is a promising strategy for extraction processes and provides the fast and efficient recovery of valuable compounds from plants and biomass with high quality. It is a simple method with high energy efficiency that shows great potential for large-scale operations. This review presents a general discussion of the mechanisms of HC, its advantages, different reactor configurations, its applications in the extraction of bioactive compounds from plants, lipids from algal biomass and delignification of lignocellulosic biomass, and a case study in which the HC extraction of basil leftovers is compared with that of other extraction methods.
Distinct and Quantitative Validation Method for Predictive Process Modelling in Preparative Chromatography of Synthetic and Bio-Based Feed Mixtures Following a Quality-by-Design (QbD) Approach
Steffen Zobel-Roos, Mourad Mouellef, Reinhard Ditz, Jochen Strube
November 24, 2019 (v1)
Keywords: biologics, continuous bioprocessing, manufacturing, Modelling, modular plants, Process Intensification, regulated industry
Process development, especially in regulated industries, where quality-by-design approaches have become a prerequisite, is cost intensive and time consuming. A main factor is the large number of experiments needed. Process modelling can reduce this number significantly by replacing experiments with simulations. However, this requires a validated model. In this paper, a process and model development workflow is presented, which focuses on implementing, parameterizing, and validating the model in four steps. The presented methods are laid out to gain, create, or generate the maximum information and process knowledge needed for successful process development. This includes design of experiments and statistical evaluations showing process robustness, sensitivity of target values to process parameters, and correlations between process and target values. Two case studies are presented. An ion exchange capture step for monoclonal antibodies focusing on high accuracy and low feed consumption;... [more]
Accelerating Biologics Manufacturing by Upstream Process Modelling
Martin Kornecki, Jochen Strube
July 25, 2019 (v1)
Subject: Biosystems
Keywords: biologics, manufacturing, Modelling, Monod kinetics, Process Intensification, upstream processing
Intensified and accelerated development processes are being demanded by the market, as innovative biopharmaceuticals such as virus-like particles, exosomes, cell and gene therapy, as well as recombinant proteins and peptides will possess no available platform approach. Therefore, methods that are able to accelerate this development are preferred. Especially, physicochemical rigorous process models, based on all relevant effects of fluid dynamics, phase equilibrium, and mass transfer, can be predictive, if the model is verified and distinctly quantitatively validated. In this approach, a macroscopic kinetic model based on Monod kinetics for mammalian cell cultivation is developed and verified according to a general valid model validation workflow. The macroscopic model is verified and validated on the basis of four decision criteria (plausibility, sensitivity, accuracy and precision as well as equality). The process model workflow is subjected to a case study, comprising a Chinese hamst... [more]
Accelerating Biologics Manufacturing by Modeling or: Is Approval under the QbD and PAT Approaches Demanded by Authorities Acceptable without a Digital-Twin?
Steffen Zobel-Roos, Axel Schmidt, Fabian Mestmäcker, Mourad Mouellef, Maximilian Huter, Lukas Uhlenbrock, Martin Kornecki, Lara Lohmann, Reinhard Ditz, Jochen Strube
June 10, 2019 (v1)
Subject: Biosystems
Keywords: biologics, continuous bioprocessing, manufacturing, Modelling, modular plants, Process Intensification, Renewable and Sustainable Energy
Innovative biologics, including cell therapeutics, virus-like particles, exosomes, recombinant proteins, and peptides, seem likely to substitute monoclonal antibodies as the main therapeutic entities in manufacturing over the next decades. This molecular variety causes a growing need for a general change of methods as well as mindset in the process development stage, as there are no platform processes available such as those for monoclonal antibodies. Moreover, market competitiveness demands hyper-intensified processes, including accelerated decisions toward batch or continuous operation of dedicated modular plant concepts. This indicates gaps in process comprehension, when operation windows need to be run at the edges of optimization. In this editorial, the authors review and assess potential methods and begin discussing possible solutions throughout the workflow, from process development through piloting to manufacturing operation from their point of view and experience. Especially,... [more]
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