100% Control of Controlled Ice Nucleation Vials by Camera-Supported Optical Inspection in Freeze-Drying
JH Lenger, R Geidobler, W Halbinger… - PDA Journal of …, 2022 - journal.pda.org
Freeze-drying is the drying technology of choice for sensitive biological drugs. On the one
side, it is admired for its suitability for the stabilization of sensitive molecules. On the other …
side, it is admired for its suitability for the stabilization of sensitive molecules. On the other …
A comparison of controlled ice nucleation techniques for freeze-drying of a therapeutic antibody
JH Gitter, R Geidobler, I Presser, G Winter - Journal of pharmaceutical …, 2018 - Elsevier
The aim of this study was to investigate if mechanistically different controlled ice nucleation
techniques in freeze-drying are comparable to each other with respect to drying process …
techniques in freeze-drying are comparable to each other with respect to drying process …
New approaches to optimize freeze-drying of monoclonal antibodies
JH Gitter - 2020 - edoc.ub.uni-muenchen.de
Over the last years, serious interest in emerging next-generation freeze-drying technologies
raised. One promising technology that stands out due to its proven benefits in food …
raised. One promising technology that stands out due to its proven benefits in food …
Comparison of ice fog methods and monitoring of controlled nucleation success after freeze-drying
I Vollrath, W Friess, A Freitag, A Hawe… - International journal of …, 2019 - Elsevier
Improving freeze-drying processes regarding drying time and batch homogeneity is subject
of ongoing research work. In this context, controlled nucleation raised great expectations …
of ongoing research work. In this context, controlled nucleation raised great expectations …
Unexplored benefits of controlled ice nucleation: lyophilization of a highly concentrated monoclonal antibody solution
SN Singh, S Kumar, V Bondar, N Wang… - International Journal of …, 2018 - Elsevier
The study explores new benefits of controlled ice nucleation during lyophilization. A highly
concentrated monoclonal antibody product was lyophilized using conventional …
concentrated monoclonal antibody product was lyophilized using conventional …
Impact of controlled ice nucleation on process performance and quality attributes of a lyophilized monoclonal antibody
D Awotwe-Otoo, C Agarabi, EK Read, S Lute… - International journal of …, 2013 - Elsevier
An efficient and potentially scalable technology was evaluated to control the ice nucleation
step of the freezing process for a model monoclonal antibody formulation and the effect on …
step of the freezing process for a model monoclonal antibody formulation and the effect on …
[HTML][HTML] Comparison of techniques to control ice nucleation during lyophilization
J Luoma, E Ingham, C Lema Martinez, A Allmendinger - Processes, 2020 - mdpi.com
Controlling ice nucleation during lyophilization of parenteral drug products increases the
homogeneity of critical quality attributes, such as residual moisture, across drug product …
homogeneity of critical quality attributes, such as residual moisture, across drug product …
New Developments in Controlled Nucleation: Commercializing VERISEQ® Nucleation Technology
J Brower, R Lee, E Wexler, S Finley, M Caldwell… - … Biologics and Vaccines …, 2015 - Springer
Freeze drying, which is also known as lyophilization, plays an important role in drug
manufacturing by stabilizing delicate pharmaceutical and biological products. The overall …
manufacturing by stabilizing delicate pharmaceutical and biological products. The overall …
Investigation of two different pressure-based controlled ice nucleation techniques in freeze-drying: the integral role of shelf temperature after nucleation in process …
T Wenzel, M Gieseler, H Gieseler - Journal of Pharmaceutical Sciences, 2020 - Elsevier
The purpose of this study was to investigate the impact of shelf temperature modifications
during application of controlled ice nucleation techniques on process data and critical …
during application of controlled ice nucleation techniques on process data and critical …
Freeze drying of pharmaceuticals in vials: Influence of freezing protocol and sample configuration on ice morphology and freeze-dried cake texture
A Hottot, S Vessot, J Andrieu - Chemical Engineering and Processing …, 2007 - Elsevier
In pharmaceutical freeze-drying processes, the freezing step is a key-step because it fixes
the morphology of the frozen material and, by the way, the final morphology of the freeze …
the morphology of the frozen material and, by the way, the final morphology of the freeze …
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