scholarly journals Accelerating Biologics Manufacturing by Modeling or: Is Approval under the QbD and PAT Approaches Demanded by Authorities Acceptable Without a Digital-Twin?

Processes ◽  
2019 ◽  
Vol 7 (2) ◽  
pp. 94 ◽  
Author(s):  
Steffen Zobel-Roos ◽  
Axel Schmidt ◽  
Fabian Mestmäcker ◽  
Mourad Mouellef ◽  
Maximilian Huter ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Process Development ◽  
Process Analytical Technology ◽  
Control Strategies ◽  
Development Stage ◽  
Point Of View ◽  
Digital Twin ◽  
Market Competitiveness ◽  
Digital Twins ◽  
Potential Methods

Innovative biologics, including cell therapeutics, virus-like particles, exosomes,recombinant proteins, and peptides, seem likely to substitute monoclonal antibodies as the maintherapeutic entities in manufacturing over the next decades. This molecular variety causes agrowing 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 decisionstoward batch or continuous operation of dedicated modular plant concepts. This indicates gaps inprocess comprehension, when operation windows need to be run at the edges of optimization. Inthis editorial, the authors review and assess potential methods and begin discussing possiblesolutions throughout the workflow, from process development through piloting to manufacturingoperation from their point of view and experience. Especially, the state-of-the-art for modeling inred biotechnology is assessed, clarifying differences and applications of statistical, rigorousphysical-chemical based models as well as cost modeling. “Digital-twins” are described and effortsvs. benefits for new applications exemplified, including the regulation-demanded QbD (quality bydesign) and PAT (process analytical technology) approaches towards digitalization or industry 4.0based on advanced process control strategies. Finally, an analysis of the obstacles and possiblesolutions for any successful and efficient industrialization of innovative methods from processdevelopment, through piloting to manufacturing, results in some recommendations. A centralquestion therefore requires attention: Considering that QbD and PAT have been required byauthorities since 2004, can any biologic manufacturing process be approved by the regulatoryagencies without being modeled by a “digital-twin” as part of the filing documentation?

The Digital Transformation of the Product Management Process: Conception of Digital Twin Impacts for the Different Stages

2019 ◽  
Vol 5 (2) ◽  
pp. 74-86 ◽  
Author(s):  
Günter Hofbauer ◽  
Anita Sangl ◽  
Sonja Engelhardt
Keyword(s):  
Digital Transformation ◽  
Point Of View ◽  
Product Management ◽  
Extensive Literature ◽  
Management Process ◽  
Digital Twin ◽  
Digital Twins ◽  
Analytical Point ◽  
Potential Benefits ◽  
Process Conception

In this paper the potential impact of digital transformation in general and digital twin applications on the Product Management Process (PMP) in particular will be investigated. The object is to figure out the potential benefits of digital twin utilization. Methodologically, a conceptual and analytical approach are applied in using statistical data, surveys, latest literature and logical conclusions. Thus, the approach is twofold: from the conceptual point of view the different types of digital twins are introduced; from the analytical point of view different applications in different stages of the PMP will be subject to investigation. So, this paper can be categorized as conceptual paper based on an extensive literature research. The findings of research revealed that the digital transformation can offer various benefits for the PMP. It can be summarized that in all phases of the PMP potential benefits can be identified. The most important is saving time and money, avoiding waste of physical resources and simultaneously raising quality, reliability and competitive advantage. Regarding the originality value it can be stated that this is the first comprehensive examination of the entire PMP with regard to digital transformation in order to identify sources of potential benefits.

scholarly journals Concept for a Supply Chain Digital Twin

2020 ◽  
Vol 5 (6) ◽  
pp. 1498-1515 ◽  
Author(s):  
Sergey Yevgenievich Barykin ◽  
Andrey Aleksandrovich Bochkarev ◽  
Olga Vladimirovna Kalinina ◽  
Vladimir Konstantinovich Yadykin
Keyword(s):  
Supply Chain ◽  
Supply Chains ◽  
Supply And Demand ◽  
Point Of View ◽  
Normal Operation ◽  
Distribution Centers ◽  
Digital Twin ◽  
Operational Risks ◽  
Digital Twins ◽  
The Impact

There is currently a discussion going on in the scientific community about using digital twins and modeling to manage risks in the supply chains. This need for constructing digital twins is caused by the low reliability and stability of supply chains due to the faults in their operation. These faults are a result of risks in the supply chains which can be consolidated into two types. The first type is operational risks. These are the current risks of the supply chain itself caused by an uncer-tainty of supply and demand as well as by an obstructed flow of information along the supply chain. The second type is critical risks caused by force majeure. These risks disrupt the normal operation of the supply chain and critically reduce the most important performance indicators of the company such as annual income and profits. Risks happen due to natural or man-made causes such as fires and floods in the distribution centers or at production facilities, legal disputes with sup-pliers, strikes, terrorist attacks on logistics facilities and others. Dynamic simulation and analytical optimization are two dominant technologies for managing risks of the supply chains, which helps to increase their reliability and stability if failures occur. Through optimizing and simulating of the supply chains, companies can generate new information about the impact of failure and influence the supply chain and its performance by looking at various scenarios that simulate the locations of failures, the duration and recovery policies. An analysis of the literary sources shows that there is no single approach to build the concept for a supply chain digital twin. This article gives an overview of the literature according to this problem and offers the author's point of view on the concept for a supply chain digital twin.

scholarly journals The Camp Nou Stadium as a Testbed for City Physiology: A Modular Framework for Urban Digital Twins

Complexity ◽  
2021 ◽  
Vol 2021 ◽  
pp. 1-15
Author(s):  
Irene Meta ◽  
Feliu Serra-Burriel ◽  
José C. Carrasco-Jiménez ◽  
Fernando M. Cucchietti ◽  
Carla Diví-Cuesta ◽  
...  
Keyword(s):  
Nonlinear Process ◽  
Point Of View ◽  
Statistical Techniques ◽  
Proof Of Concept ◽  
Agent Based ◽  
Digital Twin ◽  
Domain Specific ◽  
Digital Twins ◽  
Modular Framework

In this paper, the Camp Nou stadium is used as a testbed for City Physiology, a theoretical framework for urban digital twins. With this case study, the modularity and adaptability of the framework, originally intended for city-scale simulations, are tested on a large facility venue. As a proof of concept, several statistical techniques and an agent-based simulation platform are coupled to simulate a crowd in the stadium, and a process of four steps is followed to build the case study. Both the conceptual (interdomain) and technical (domain specific) layers of the digital twin are defined and connected in a nonlinear process so that they represent the complexity of the object to be simulated. The result obtained is a strategy to build a digital twin from the domain point of view, paving the way for more complex, more ambitious simulators.

scholarly journals DIGITAL TWINS AND THEIR APPLIANCE IN TRANSPORT ECONOMICS

2021 ◽  
Vol 12 (2) ◽  
pp. 127-137
Author(s):  
O. N. Rimskaya ◽  
I. V. Anokhov
Keyword(s):  
Division Of Labor ◽  
Point Of View ◽  
Real Economy ◽  
Information Economy ◽  
The Real ◽  
Digital Twin ◽  
Digital Twins ◽  
Transport Industry ◽  
Definition Of Information ◽  
The Impact

Today digitalization increasingly affects the economy, including the transport industry. The consequence of this is the emergence of digital twins that allow modeling and predicting the behavior of both individual processes and enterprises as a whole.The aim of the article is to investigate the process of digitalization in the transport industry. The theoretical basis of the article was the universal organizational science of A. Bogdanov.The article offers a definition of information, and its classification in relation to the economy at three levels: applied information (technological information), information about algorithms of the owners of factors production behavior (behavioral information) and information, with which the impact on the owners of production factors and the real economy in general (directive information). The totality of these levels of information from the macroeconomic point of view forms an information economy, and from the microeconomic point of view – a digital twin of a particular subject of the real economy.It is proved that the digital economy is a subsystem of the information economy, differs in a binary way of presenting information and is maximally oriented to the management of the real economy.Information precedes all activity, so the real economy is a product of the information economy. Consequently, the technological division of labor is based on a prior informational division of labor. This theoretically allows us to judge the adequacy of the digital twin through the analysis of individual technological levels of the transport enterprise. This hypothesis was applied to the analysis of the Russian railway transport, which gave reason to consider this approach promising for use at macro- and micro-levels both.

scholarly journals Impedance Matching-Based Power Flow Analysis for UPQC in Three-Phase Four-Wire Systems

Energies ◽  
2021 ◽  
Vol 14 (9) ◽  
pp. 2702
Author(s):  
Xiaojun Zhao ◽  
Xiuhui Chai ◽  
Xiaoqiang Guo ◽  
Ahmad Waseem ◽  
Xiaohuan Wang ◽  
...  
Keyword(s):  
Power Flow ◽  
Control Strategies ◽  
Impedance Matching ◽  
Flow Analysis ◽  
Point Of View ◽  
Impedance Model ◽  
Power Flow Analysis ◽  
Three Phase ◽  
System Node ◽  
Power Quality Conditioner

Different from the extant power flow analysis methods, this paper discusses the power flows for the unified power quality conditioner (UPQC) in three-phase four-wire systems from the point of view of impedance matching. To this end, combined with the designed control strategies, the establishing method of the UPQC impedance model is presented, and on this basis, the UPQC system can be equivalent to an adjustable impedance model. After that, a concept of impedance matching is introduced into this impedance model to study the operation principle for the UPQC system, i.e., how the system changes its operation states and power flow under the grid voltage variations through discussing the matching relationships among node impedances. In this way, the nodes of the series and parallel converter are matched into two sets of impedances in opposite directions, which mean that one converter operates in rectifier state to draw the energy and the other one operates in inverter state to transmit the energy. Consequently, no matter what grid voltages change, the system node impedances are dynamically matched to ensure that output equivalent impedances are always equal to load impedances, so as to realize impedance and power balances of the UPQC system. Finally, the correctness of the impedance matching-based power flow analysis is validated by the experimental results.

Digital Twin for Smart Manufacturing: The Practitioner’s Perspective

2020 ◽  
Author(s):  
Maja Bärring ◽  
Björn Johansson ◽  
Goudong Shao
Keyword(s):  
Conceptual Development ◽  
Production Systems ◽  
Manufacturing Sector ◽  
Smart Manufacturing ◽  
Digital Twin ◽  
Adoption And Implementation ◽  
New Information ◽  
Digital Twins ◽  
Discrete Manufacturing ◽  
Design Production

Abstract The manufacturing sector is experiencing a technological paradigm shift, where new information technology (IT) concepts can help digitize product design, production systems, and manufacturing processes. One of such concepts is Digital Twin and researchers have made some advancement on both its conceptual development and technological implementations. However, in practice, there are many different definitions of the digital-twin concept. These different definitions have created a lot of confusion for practitioners, especially small- and medium-sized enterprises (SMEs). Therefore, the adoption and implementation of the digital-twin concept in manufacturing have been difficult and slow. In this paper, we report our findings from a survey of companies (both large and small) regarding their understanding and acceptance of the digital-twin concept. Five supply-chain companies from discrete manufacturing and one trade organization representing suppliers in the automotive business were interviewed. Their operations have been studied to understand their current digital maturity levels and articulate their needs for digital solutions to stay competitive. This paper presents the results of the research including the viewpoints of these companies in terms of opportunities and challenges for implementing digital twins.

Machine learning-based digital twins reduce seasonal remapping in aeroderivative gas turbines

2021 ◽  
pp. 1-7
Author(s):  
Nick Petro ◽  
Felipe Lopez
Keyword(s):  
Machine Learning ◽  
Ambient Temperature ◽  
Gas Turbines ◽  
Operating Conditions ◽  
Pilot Site ◽  
Digital Twin ◽  
Digital Twins ◽  
Machine Learning Model ◽  
Unacceptable Behavior ◽  
External Conditions

Abstract Aeroderivative gas turbines have their combustion set points adjusted periodically in a process known as remapping. Even turbines that perform well after remapping may produce unacceptable behavior when external conditions change. This article introduces a digital twin that uses real-time measurements of combustor acoustics and emissions in a machine learning model that tracks recent operating conditions. The digital twin is leveraged by an optimizer that select adjustments that allow the unit to maintain combustor dynamics and emissions in compliance without seasonal remapping. Results from a pilot site demonstrate that the proposed approach can allow a GE LM6000PD unit to operate for ten months without seasonal remapping while adjusting to changes in ambient temperature (4 - 38 °C) and to different fuel compositions.

Digital Twins: Review and Challenges

2021 ◽  
Vol 21 (3) ◽  
Author(s):  
Maria G. Juarez ◽  
Vicente J. Botti ◽  
Adriana S. Giret
Keyword(s):  
Computer Science ◽  
Industry 4.0 ◽  
Multi Agent System ◽  
Agent System ◽  
Digital Twin ◽  
Digital Twins ◽  
Science Approach ◽  
Multi Agent ◽  
Current Operating

Abstract With the arises of Industry 4.0, numerous concepts have emerged; one of the main concepts is the digital twin (DT). DT is being widely used nowadays, however, as there are several uses in the existing literature; the understanding of the concept and its functioning can be diffuse. The main goal of this paper is to provide a review of the existing literature to clarify the concept, operation, and main characteristics of DT, to introduce the most current operating, communication, and usage trends related to this technology, and to present the performance of the synergy between DT and multi-agent system (MAS) technologies through a computer science approach.

The Digital Twin of a System: A Structure for Networks of Digital Twins

2021 ◽  
Author(s):  
Leif- Thore Reiche ◽  
Claas Steffen Gundlach ◽  
Gian Frederik Mewes ◽  
Alexander Fay
Keyword(s):  
Digital Twin ◽  
System A ◽  
Digital Twins

Engine Fleet-Management: The Use of Digital Twins From a MRO Perspective

2017 ◽  
Author(s):  
Joern Kraft ◽  
Stefan Kuntzagk
Keyword(s):  
Multilevel Models ◽  
Operating Cost ◽  
Maintenance Cost ◽  
Fleet Management ◽  
Component Level ◽  
The Real ◽  
Digital Twin ◽  
Digital Twins ◽  
The Individual ◽  
Life Consumption

Engine operating cost is a major contributor to the direct operating cost of aircraft. Therefore, the minimization of engine operating cost per flight-hour is a key aspect for airlines to operate successfully under challenging market conditions. The interaction between maintenance cost, operating cost, asset value, lease and replacement cost describes the area of conflict in which engine fleets can be optimized. State-of-the-art fleet management is based on advanced diagnostic and prognostic methods on engine and component level to provide optimized long-term removal and work-scoping forecasts on fleet level based on the individual operation. The key element of these methods is a digital twin of the active engines consisting of multilevel models of the engine and its components. This digital twin can be used to support deterioration and failure analysis, predict life consumption of critical parts and relate the specific operation of a customer to the real and expected condition of the engines on-wing and at induction to the shop. The fleet management data is constantly updated based on operational data sent from the engines as well as line maintenance and shop data. The approach is illustrated along the real application on the CFM56-5C, a mature commercial two-spool high bypass engine installed on the Airbus A340-300. It can be shown, that the new methodology results in major improvements on the considered fleets.

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