Výsledky vyhledávání - "Heribert Helgers"

Scalable mRNA Machine for Regulatory Approval of Variable Scale between 1000 Clinical Doses to 10 Million Manufacturing Scale Doses

Autor: Alina Hengelbrock, Axel Schmidt, Heribert Helgers, Florian Lukas Vetter, Jochen Strube

Publikováno v: Processes
Volume 11
Issue 3
Pages: 745

The production of messenger ribonucleic acid (mRNA) and other biologics is performed primarily in batch mode. This results in larger equipment, cleaning/sterilization volumes, and dead times compared to any continuous approach. Consequently, producti

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Digital Twins for Continuous Biologics Manufacturing

Autor: Axel Schmidt, Steffen Zobel‐Roos, Heribert Helgers, Lara Lohmann, Florian Vetter, Christoph Jensch, Alex Juckers, Jochen Strube

Publikováno v: Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing. :265-350

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https://doi.org/10.1002/9783527827343.ch9

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Towards Autonomous Process Control—Digital Twin for HIV-Gag VLP Production in HEK293 Cells Using a Dynamic Metabolic Model

Autor: Heribert Helgers, Alina Hengelbrock, Jamila Franca Rosengarten, Jörn Stitz, Axel Schmidt, Jochen Strube

Publikováno v: Processes; Volume 10; Issue 10; Pages: 2015
Processes : open access journal 10 (2022), Nr. 10
Processes : open access journal

Despite intensive research over the last three decades, it has not yet been possible to bring an effective vaccine against human immunodeficiency virus (HIV) and the resulting acquired immunodeficiency syndrome (AIDS) to market. Virus-like particles

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Process Automation and Control Strategy by Quality-by-Design in Total Continuous mRNA Manufacturing Platforms

Autor: Axel Schmidt, Heribert Helgers, Florian Lukas Vetter, Steffen Zobel-Roos, Alina Hengelbrock, Jochen Strube

Publikováno v: Processes; Volume 10; Issue 9; Pages: 1783

Vaccine supply has a bottleneck in manufacturing capacity due to operation personnel and chemicals needed. Assessment of existing mRNA (messenger ribonucleic acid) vaccine processing show needs for continuous manufacturing processes. This is enabled

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Digital twins for scFv production in Escherichia coli

Autor: Heribert Helgers, Alina Hengelbrock, Axel Schmidt, Florian Lukas Vetter, Alex Juckers, Jochen Strube

Publikováno v: Processes; Volume 10; Issue 5; Pages: 809

Quality-by-Design (QbD) is demanded by regulatory authorities in biopharmaceutical production. Within the QbD frame advanced process control (APC), facilitated through process analytical technology (PAT) and digital twins (DT), plays an increasingly

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https://dokumente.ub.tu-clausthal.de/servlets/MCRFileNodeServlet/clausthal_derivate_00001881/processes-10-00809.pdf

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Process design and optimization towards digital twins for HIV-gag VLP production in HEK293 cells, including purification

Autor: Heribert Helgers, Alina Hengelbrock, Axel Schmidt, Jamila Rosengarten, Jörn Stitz, Jochen Strube

Publikováno v: Processes; Volume 10; Issue 2; Pages: 419

Despite great efforts to develop a vaccine against human immunodeficiency virus (HIV), which causes AIDS if untreated, no approved HIV vaccine is available to date. A promising class of vaccines are virus-like particles (VLPs), which were shown to be

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https://dokumente.ub.tu-clausthal.de/servlets/MCRFileNodeServlet/clausthal_derivate_00001653/processes-10-00419.pdf

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Towards autonomous process control: digital twin for CHO cell-based antibody manufacturing using a dynamic metabolic model

Autor: Heribert Helgers, Axel Schmidt, Jochen Strube

Publikováno v: Processes; Volume 10; Issue 2; Pages: 316

The development of new biologics is becoming more challenging due to global competition and increased requirements for process understanding and assured quality in regulatory approval. As a result, there is a need for predictive, mechanistic process

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Process analytical technology as key-enabler for digital twins in continuous biomanufacturing

Autor: Axel Schmidt, Heribert Helgers, Lara Julia Lohmann, Florian Vetter, Alex Juckers, Mourad Mouellef, Steffen Zobel‐Roos, Jochen Strube

Over the last few years rapid progress has been made in adopting well-known process modeling techniques from chemicals to biologics manufacturing. The main challenge has been analytical methods as engineers need quantitative data for their workflow.

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https://dokumente.ub.tu-clausthal.de/receive/clausthal_mods_00002179

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Towards Autonomous Operation by Advanced Process Control—Process Analytical Technology for Continuous Biologics Antibody Manufacturing

Autor: Axel Schmidt, Alex Juckers, Lara Julia Lohmann, Steffen Zobel-Roos, Christoph Jensch, Florian Lukas Vetter, Mourad Mouellef, Jochen Strube, Heribert Helgers

Publikováno v: Processes, Vol 9, Iss 172, p 172 (2021)
Processes
Volume 9
Issue 1

Continuous manufacturing opens up new operation windows with improved product quality in contrast to documented lot deviations in batch or fed-batch operations. A more sophisticated process control strategy is needed to adjust operation parameters an

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https://www.mdpi.com/2227-9717/9/1/172

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Digital Twin for HIV-Gag VLP Production in HEK293 Cells

Autor: Alina Hengelbrock, Heribert Helgers, Axel Schmidt, Florian Lukas Vetter, Alex Juckers, Jamila Franca Rosengarten, Jörn Stitz, Jochen Strube

Publikováno v: Processes; Volume 10; Issue 5; Pages: 866

The development and adoption of digital twins (DT) for Quality-by-Design (QbD)-based processes with flexible operating points within a proven acceptable range (PAR) and automation through Advanced Process Control (APC) with Process Analytical Technol

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e687dc5c645564c6e02fc0b6492bc815
https://doi.org/10.3390/pr10050866

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