Zobrazeno 1 - 8
of 8
pro vyhledávání: '"Michael Dekner"'
Autor:
Stephan Sacher, Johannes Poms, Michael Dekner, Sabine Wallner-Mang, Martin Vogt, Johannes G. Khinast, Robert Schennach
Publikováno v:
International Journal of Pharmaceutics: X, Vol 3, Iss , Pp 100101- (2021)
The presence of particulate matter in parenteral products is a major concern since it affects the patients' safety and is one of the main reasons for product recalls. Conventional quality control is based on a visual inspection, which is a labour-int
Externí odkaz:
https://doaj.org/article/c7b003f8490e4d46a7c66157186484e3
Autor:
Barbara Pretzner, Christopher Taylor, Filip Dorozinski, Michael Dekner, Andreas Liebminger, Christoph Herwig
Publikováno v:
Bioengineering, Vol 7, Iss 2, p 50 (2020)
Process monitoring is a critical task in ensuring the consistent quality of the final drug product in biopharmaceutical formulation, fill, and finish (FFF) processes. Data generated during FFF monitoring includes multiple time series and high-dimensi
Externí odkaz:
https://doaj.org/article/88a26174e4c541aabb235692408802c1
Autor:
Ekneet Sahni, Bert Van Meervenne, Stefan Schneid, Michael Dekner, Sonia Bedi, Xiaolin Tang, David A. Hamilton, Orla McGarvey, Martin Frei, Nunzio Zinfollino, Edwin Vilanova Velez, Michael Gosmer, Deborah Hill
Publikováno v:
Journal of Pharmaceutical Sciences. 111:2714-2718
The vacuum integrity of freeze dryers is critical for attaining adequate process control and maintaining confidence in sterility assurance which is key for the manufacture of sterile pharmaceutical products. Although discussions on the topic have bee
Autor:
Serguei Tchessalov, Evgenyi Shalaev, Bakul Bhatnagar, Steven Nail, Alina Alexeenko, Feroz Jameel, Jayasree Srinivasan, Michael Dekner, Ekneet Sahni, Stefan Schneid, Petr Kazarin, Orla McGarvey, Bert Van Meervenne, Vaibhav Kshirsagar, Paritosh Pande, Jens Philipp, Greg Sacha, Ke Wu, Joseph Azzarella, Gayathri Shivkumar, Shreyas Bhatt, Shyam B. Mehta
Publikováno v:
AAPS PharmSciTech. 24
Scale-up and transfer of lyophilization processes remain very challenging tasks considering the technical challenges and the high cost of the process itself. The challenges in scale-up and transfer were discussed in the first part of this paper and i
Publikováno v:
Pharmaceutical Research.
Objectives Solid biopharmaceutical products can circumvent lower temperature storage and transport and increase remote access with lower carbon emissions and energy consumption. Saccharides are known stabilizers in a solid protein produced via lyophi
Autor:
Serguei Tchessalov, Evgenyi Shalaev, Bakul Bhatnagar, Steven Nail, Alina Alexeenko, Feroz Jameel, Jayasree Srinivasan, Michael Dekner, Ekneet Sahni, Stefan Schneid, Petr Kazarin, Orla McGarvey, Bert Van Meervenne, Vaibhav Kshirsagar, Paritosh Pande, Jens Philipp, Greg Sacha, Ke Wu, Joseph Azzarella, Gayathri Shivkumar, Shreyas Bhatt
Publikováno v:
AAPS PharmSciTech. 24
The freeze-drying process scale-up and transfer remain a complicated and non-uniform practice. We summarized inefficient and good practices in these papers and provided some practical advice. It was demonstrated that using the same process set points
Autor:
Christian Makert, Michael Dekner, Joana T. Pinto, Johanna Dieplinger, Marco Nieder, Amrit Paudel, Eva Faulhammer
Publikováno v:
Drying Technology. 39:1415-1446
Spray-drying is an inherently continuous and well-established industrial drying process. It can accelerate manufacturing of biopharmaceuticals and vaccine products, resulting in both an economic an...
Autor:
Matthias Nixdorf, Robert Schennach, Johannes Poms, Stephan Sacher, Johannes Khinast, Sabine Wallner-Mang, Michael Dekner, Ines Janssen
Publikováno v:
Pharmaceutical Development and Technology. 24:739-750
An undesirable characteristic in lyophilized parenteral products is the potential presence of particulate matter in the final product, which may affect patient safety. In this study, quality risk management tools described in the International Confer