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Development and Application of a Mechanistic Cooling and Freezing Model of the Spin Freezing Step within the Framework of Continuous Freeze-Drying [PDF]

open access: yesPharmaceutics, 2021
During the spin freezing step of a recently developed continuous spin freeze-drying technology, glass vials are rapidly spun along their longitudinal axis.
Gust Nuytten   +9 more
doaj   +7 more sources

A NIR-Based Study of Desorption Kinetics during Continuous Spin Freeze-Drying [PDF]

open access: yesPharmaceutics, 2021
The pharmaceutical industry is progressing toward the development of more continuous manufacturing techniques. At the same time, the industry is striving toward more process understanding and improved process control, which requires the implementation of
Laurens Leys   +6 more
doaj   +6 more sources

Continuous freeze-drying of messenger RNA lipid nanoparticles enables storage at higher temperatures [PDF]

open access: yesJournal of Controlled Release, 2023
Messenger RNA (mRNA) lipid nanoparticles (LNPs) have emerged at the forefront during the COVID-19 vaccination campaign. Despite their tremendous success, mRNA vaccines currently require storage at deep freeze temperatures which complicates their storage and distribution, and ultimately leads to lower accessibility to low- and middle-income countries ...
Thomas De Beer   +2 more
exaly   +5 more sources

A primary drying model-based comparison of conventional batch freeze-drying to continuous spin-freeze-drying for unit doses [PDF]

open access: yesEuropean Journal of Pharmaceutics and Biopharmaceutics, 2020
An innovative continuous spin-freeze-drying technology for unit doses was recently developed. For this technology, a mechanistic primary drying model was developed allowing the calculation of the optimal dynamic drying trajectory for spin-frozen formulations.
Chris Vervaet
exaly   +3 more sources

Spray Freeze-Drying as a Solution to Continuous Manufacturing of Pharmaceutical Products in Bulk [PDF]

open access: yesProcesses, 2020
Pharmaceutical manufacturing is evolving from traditional batch processes to continuous ones. The new global competition focused on throughput and quality of drug products is certainly the driving force behind this transition which, thus, represents the new challenge of pharmaceutical manufacturing and hence of lyophilization as a downstream operation.
Antonello Barresi   +2 more
exaly   +3 more sources

Stabilization strategies and advancements in lyophilization to preserve integrity and efficacy of next-generation biologicals [PDF]

open access: yesInternational Journal of Pharmaceutics: X
The success of mRNA-lipid nanoparticles (LNPs) vaccines during the COVID-19 pandemic has significantly increased global demand for stable, thermo-resistant biologicals.
Ravi Maharjan   +9 more
doaj   +2 more sources

Evaluation of spin freezing versus conventional freezing as part of a continuous pharmaceutical freeze-drying concept for unit doses [PDF]

open access: yesInternational Journal of Pharmaceutics, 2015
Spin-freezing as alternative freezing approach was evaluated as part of an innovative continuous pharmaceutical freeze-drying concept for unit doses. The aim of this paper was to compare the sublimation rate of spin-frozen vials versus traditionally frozen vials in a batch freeze-dryer, and its impact on total drying time.
T De Beer, J P Remon, J P Remon
exaly   +3 more sources

Mechanistic modelling of infrared mediated energy transfer during the primary drying step of a continuous freeze-drying process [PDF]

open access: yesEuropean Journal of Pharmaceutics and Biopharmaceutics, 2017
Conventional pharmaceutical freeze-drying is an inefficient and expensive batch-wise process, associated with several disadvantages leading to an uncontrolled end product variability. The proposed continuous alternative, based on spinning the vials during freezing and on optimal energy supply during drying, strongly increases process efficiency and ...
Thomas De Beer   +2 more
exaly   +4 more sources

Recent trends in pharmaceutical freeze-drying and control strategies observed in human drug applications and manufacturing inspections [PDF]

open access: yesAAPS Open
Freeze-drying has been a workhorse for the pharmaceutical industry to enable long-term storage and long-distance transport of drug products that are unstable in liquid or frozen form.
Steve Y. Rhieu   +5 more
doaj   +2 more sources

Evaluating the impact of annealing and radiative cooling on a PEGylated peptide formulation subjected to continuous spin-freeze-drying

open access: yesAAPS Open
Annealing is commonly used in traditional lyophilization processes to crystallize solutes, improve drying efficiency and reduce cake heterogeneity, yet its integration into continuous spin-freeze-drying has not yet been reported.
Zarah Schaal   +7 more
doaj   +2 more sources

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