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Issue #5 2015 – Digital edition
In Issue #5 2015: Counterfeit Drugs, Regulatory Insight, Raman In-Depth Focus, PAT Series, Polymorphs, RMM In-Depth Focus, Particle Sizing, Freeze Drying, and much more...
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Freeze Drying
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Dynamic vapour sorption of freeze-dried pharmaceuticals
22 October 2015 | By Claudia Kunz and Henning Gieseler, Department of Pharmaceutics, University of Erlangen
Freeze drying is gaining in importance as the number of biopharmaceuticals that are unstable in a solution increases. According to recent reports, a growth of 10% may be expected for freeze-dried products in the next 10 years. The technique offers the opportunity to gently dry temperature-sensitive drugs such as proteins…
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Issue #3 2014 – Digital edition
In Issue #3 2014: Pharmaceutical freeze-drying, Self-amplifying mRNA vaccines, Polymorph myths, Microbiology focus, NMR for isotope profiling, Manufacturing with QbD 2.0, Single-cell mRNA-Sequencing, qPCR focus, Powder Flow...
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Techniques to preserve product quality in pharmaceutical freeze drying
In a pharmaceutical freeze drying process, it is mandatory to preserve product quality. This means that for a given formulation that has to be freeze dried, the temperature has to remain below a limit value corresponding to the eutectic temperature for a product that crystallises after freezing, with the goal…
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Controlled nucleation in freeze-drying
22 October 2012 | By Henning Gieseler, Associate Professor at the Division of Pharmaceutics, University of Erlangen & CEO, GILYOS GmbH and Peter Stärtzel, Pharmaceutical Scientist, GILYOS GmbH
The stochastic nature of nucleation during the freezing step of the freeze-drying process has been regarded as a demerit in a process which is considered under rigorous control. The freezing performance of a product can impact its subsequent drying behaviour and the final product quality attributes. Hence, the idea to…
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Stabilisation of nanoparticles during freeze drying: The difference to proteins
31 August 2011 | By Jakob Beirowski and Henning Gieseler, University of Erlangen-Nuremberg, Division of Pharmaceutics, Freeze Drying Focus Group
The underlying concept for the stabilisation of proteins during freeze drying is the formation of a glassy matrix in which the macromolecules remain isolated and immobilised. The concept relies on the so-called ‘vitrification hypothesis’ which assumes that the formation of an amorphous phase by lyoprotectants is mandatory to interact with…
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Primary packaging materials for pharmaceutical freeze-drying: Moulded vs. serum tubing vials
19 August 2010 | By Susanne Hibler and Dr. Henning Gieseler, University of Erlangen-Nuremberg, Division ofPharmaceutics, Freeze Drying Focus Group
Pharmaceutical freeze-drying is used to stabilise delicate drugs which are typically unstable in solution over a longer shelf life. The liquid formulation is converted into a solid, highly porous cake which can be easily reconstituted prior to administration. The majority of freeze-dried products in the pharmaceutical industry are used for…
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Process Analytical Technology (PAT) in Freeze Drying: Tunable Diode Laser Absorption Spectroscopy as an evolving tool for Cycle Monitoring
12 December 2009 | By Stefan Schneid, Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen-Nuremberg and Dr. Henning Gieseler, Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen-Nuremberg
The most important critical product parameter during a freeze-drying process is the product temperature at the ice sublimation interface, Tp1. Once the product temperature in this area of interest exceeds the critical formulation temperature (typically denoted as "collapse temperature", Tc) during primary drying, a stepwise loss of the cake structure…
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The determination of structural changes of biopharmaceuticals during Freeze-Drying using Fourier Transform Infrared Spectroscopyb
Peptides and proteins are powerful active therapeutic ingredients used in a wide variety of serious conditions and illnesses such as diabetes, arthritis or cancer. The application of these so-called biopharmaceuticals has been rapidly increasing since the middle of the 1990s, facilitated by improvements in modern recombinant DNA technology and biotechnological…
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Application of DSC and MDSC in the development of freeze dried pharmaceuticals
3 December 2008 | By Jakob Beirowski, Pharmacist and Dr. Henning Gieseler, Assistant Professor, Division of Pharmaceutics, University of Erlangen-Nuremberg
Freeze drying of pharmaceuticals requires an adequate formulation design to prevent low-temperature, freezing and drying stresses. The goal is to achieve a final product with long storage stability and elegant appearance. To meet these specifications the product temperature must be controlled below the critical formulation temperature during the freeze drying…
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A significant comparison between collapse and glass transition temperatures
29 September 2008 | By Eva Meister and Dr. Henning Gieseler, Division of Pharmaceutics, University of Erlangen-Nuremberg
Rational freeze-drying process design is based on a representative and accurate measurement of the critical formulation temperature. To avoid product shrinkage or collapse, it is indispensable to control the product temperature just below this key temperature during primary drying. Over the last decades, DSC was routinely used to determine the…
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Lyophilization: cycle robustness and process tolerances, transfer and scale up
19 June 2008 | By Serguei Tchessalov and Nicholas Warne, Wyeth BioPharma, Andover
During the past 10-15 years, close attention has been paid to the development of optimal lyophilization cycles for different types of pharmaceuticals1-4. Recent advances in process control, such as the Smart Freeze-DryerTM technology or similar approaches, [5-7] make cycle development a routine procedure. The attention of many researchers has shifted…
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Spray-freeze-drying in the manufacture of pharmaceuticals
Over the last decade, the development of new drug delivery methods and devices for dry powder inhalation1, needle-free intradermal powder injection2 or sustained parenteral drug delivery3 has led to an increasing demand for powder formulations incorporating an active pharmaceutical ingredient (API)4,5.
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PAT for freeze drying: cycle optimisation in the laboratory
25 January 2007 | By Dr. Henning Gieseler, PhD., Department of Pharmaceutics, University of Erlangen-Nuremberg
Freeze drying is generally known to be a time consuming and therefore expensive process. In order to lower costs during manufacturing, the effective cycle time must be reduced. This goal can be achieved by optimising a freeze drying cycle in the laboratory – in particular the primary drying phase. Applying…
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Lyophilization: An ever-evolving technology
23 May 2006 | By Prof. Louis Rey, Scientific Advisor and Head, Laboratory of Experimental Freeze-Drying AERIAL – CRT, and Dalal Aoude-Werner, Head of Project, AERIAL – CRT
Almost 60 years have elapsed since freeze-drying/lyophilization was introduced on an industrial scale. Developed initially for the rapid delivery of human blood plasma on the World’s battle fields, lyophilization gained its credentials with the massive production of penicillin under the guidance of the late Nobel Laureate Sir Ernst Boris Chain.
