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14
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124
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Citations since 2017
Introduction
Additional affiliations
December 2014 - present
September 2010 - August 2011
September 2010 - October 2014
Education
June 2009 - January 2010
October 2008 - September 2014
Publications
Publications (14)
The implementation of continuous pharmaceutical manufacturing requires advanced control strategies rather than traditional end product testing or an operation within a small range of controlled parameters. A high level of automation based on process models and hierarchical control concepts is desired. The relevant tools that have been developed and...
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-intensive task. Limited to clear solutions and the surface of lyophilised products, it cannot be applie...
To avoid any type of cross-contamination, residue-free production equipment is of utmost importance in the pharmaceutical industry. The equipment cleaning for continuous processes such as hot melt extrusion (HME), which has recently gained popularity in pharmaceutical applications, necessitates extensive manual labour and costs. The present work ta...
Isolators for aseptic filling of biopharmaceuticals and vaccine products are commonly sanitized by vaporized hydrogen peroxide (VHP). However, remaining traces of H2O2 may contaminate the solution and cause oxidative degradation of the pharmaceutical products. The present report aims to establish a thorough understanding of the factors influencing...
Inline benchtop NMR analysis is established as a powerful tool for reaction monitoring, but its capabilities are somewhat limited by low spectral resolution, often leading to overlapping peaks and difficulties in quantification. Using a multivariate analysis (MVA) statistical approach to data processing these hurdles can be overcome, enabling accur...
The aim of the current study was to characterize the robustness of an integrated continuous direct compression (CDC) line against disturbances from feeding, i.e. impulses of API and short step disturbances. These disturbances mimicked typical variations that can be encountered during long-term manufacture. The study included a primary formulation,...
The objective of this study was to develop a novel closed-loop controlled continuous tablet manufacturing line, which first uses hot melt extrusion (HME) to produce pellets based on API and a polymer matrix. Such systems can be used to make complex pharmaceutical formulations, e.g., amorphous solid dispersions of poorly soluble APIs. The pellets ar...
An undesirable characteristic in lyophilized parenteral products is the potential presence of particulate matter in the final product, which may affects the patient safety. In this study, quality risk management tools described in the International Conference on Harmonization Guideline Q9 were used to estimate the risks for a pharmaceutical manufac...
The effect of different irradiation doses on the structure and activity of lyophilized powders of Hen Egg-White Lysozyme (HEWL) and alcohol dehydrogenase (ADH) was investigated using these substances as models for robust and sensitive proteins, respectively. Three doses were selected to cover the ranges of radio-sterilization (25kGy), treatment of...
We report on the spectroscopic investigation of lithium atoms and lithium dimers in their triplet manifold on the surface of helium nanodroplets (HeN). We present the excitation spectrum of the 3p ← 2s and 3d ← 2s two-photon transitions for single Li atoms on HeN. The atoms are excited from the 2S(Σ) ground state into Δ, Π and Σ pseudo-diatomic mol...
Chemical reactions in the cold environment of a helium nanodroplet currently attract high interest and can be spectroscopically observed with typical molecular beam techniques. In order to estimate the influence of surrounding helium on the van der Waals interaction between heliophilic and heliophobic dopants that could be investigated in our lab w...
In this work we apply density-functional theory to simulate a double-dotation of He-clusters with Rb and Xe atoms. We investigate the influence of the He droplet environment on the weak van der Waals interaction between xenon and rubidium. The heliophilic Xe resides inside the droplet, while the heliophobic Rb stays on its surface. The effect of th...
Our recent development of electron spin resonance (ESR) spectroscopy on superfluid helium nanodroplets (HeN) provides a sensitive tool to investigate interactions between a surface located alkali-metal atom and an ESR silent species inside the droplet. Highest sensitivity is expected for alkali-metal atoms with large hyperfine coupling. We present...
Hyperfine resolved electron spin resonance (ESR) measurements of single rubidium ((87)Rb) atoms isolated on superfluid helium nanodroplets are presented. In accordance with our previous work on (85)Rb, we find a relative increase of the hyperfine constant a(HFS) by about 400 ppm, depending on the size of the droplets. In order to optimize the ESR s...
Projects
Projects (3)
TDLAS is the major technology for inline headspace analysis.
X-ray radiationcan be implemented for sterilization ofpharmaceutical proteins or detection of impurities of protein products.Irradiation has a dose dependent negative effect on proteins causing changes in the protein structure and in severe cases inactivation. Therefore, the radiation dose for the detection of impurities has to be chosen accordingly. In this study we compared the impact of 25 kGy, 25 Gy and 2 mGy to the impact of heat stress on freeze-dried ADH and lysozyme. The effects of X-rays were determined by enzyme activity assays, DSC and SWAXS.
