Zobrazeno 1 - 9
of 9
pro vyhledávání: '"Alex Juckers"'
Publikováno v:
Pharmaceutics, Vol 14, Iss 4, p 809 (2022)
Lyophilization process design still relies mainly on empirical studies with high experimental loads. In the regulatory demanded Quality by Design approach, process modeling is a key aspect. It allows process design, optimization and process control t
Externí odkaz:
https://doaj.org/article/b1b6476ac52041a9a02b686a65b717f1
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::68bf7fc283f66ac9cf735002d5ae00c0
https://doi.org/10.1002/9783527827343.ch9
https://doi.org/10.1002/9783527827343.ch9
Effect of the Freezing Step on Primary Drying Experiments and Simulation of Lyophilization Processes
Publikováno v:
Processes; Volume 11; Issue 5; Pages: 1404
Lyophilization is a widely used preservation method for thermosensitive products. It consists of three process steps: freezing, primary and secondary drying. One of the major drawbacks is the long processing time. The main optimization effort was put
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b2d879303a42faca6351c1eb702bc60c
https://doi.org/10.3390/pr11051404
https://doi.org/10.3390/pr11051404
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::79cf68c641c6794f8024e887283a57dc
https://dokumente.ub.tu-clausthal.de/servlets/MCRFileNodeServlet/clausthal_derivate_00001881/processes-10-00809.pdf
https://dokumente.ub.tu-clausthal.de/servlets/MCRFileNodeServlet/clausthal_derivate_00001881/processes-10-00809.pdf
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.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d1e71715e69a8d678ee116cb7c94cbc4
https://dokumente.ub.tu-clausthal.de/receive/clausthal_mods_00002179
https://dokumente.ub.tu-clausthal.de/receive/clausthal_mods_00002179
Publikováno v:
Processes; Volume 10; Issue 10; Pages: 2059
Lyophilization is a widely used drying operation, but long processing times are a major drawback. Most lyophilization processes are conducted by a recipe that is not changed or optimized after implementation. With the regulatory demanded quality by d
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::31a4ae3d9ca133d25432e68763016a55
https://doi.org/10.3390/pr10102059
https://doi.org/10.3390/pr10102059
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
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
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c1c8076ad5484cd24946f1f6d4c47e44
https://www.mdpi.com/2227-9717/9/1/172
https://www.mdpi.com/2227-9717/9/1/172
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
https://doi.org/10.3390/pr10050866
Publikováno v:
Processes
Volume 8
Issue 10
Processes, Vol 8, Iss 1325, p 1325 (2020)
Volume 8
Issue 10
Processes, Vol 8, Iss 1325, p 1325 (2020)
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 Qualit
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5fed901f2115437f66a869db4f4949b3