Pascal Chalus- PhD
- Senior Principal Scientist at Roche
Pascal Chalus
- PhD
- Senior Principal Scientist at Roche
About
23
Publications
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Publications (23)
The aim of this study was to investigate the in-use compatibility of eight commercially available closed system transfer device brands (CSTDs) with a formulated model antibody drug conjugate (ADC). Overall, in-use simulated dosing preparation applying the CSTD systems investigated raised concerns for several product quality attributes. The incompat...
Visible particles are a critical quality attribute for parenteral products and must be monitored. A carefully designed, executed, and controlled drug product manufacturing process including a final 100% visual inspection and appropriate end-product controls ensures that visible particles are consistently minimized and demonstrates that the injectab...
Degradation of polysorbates in biopharmaceutical formulations can induce the formation of sub-visible particles (SvPs) in the form of free-fatty acids (FFAs) and potentially protein aggregates. Flow-imaging microscopy (FIM) is one of the most common techniques for enumerating and characterizing the SvPs, allowing for collection of image data of the...
This patents describes the setup of a solid fraction measurement for roller compaction process.
The measurement of polydisperse protein aggregates and particles in biotherapeutics remains a challenge, especially for particles with diameters of ≈ 1 µm and below (sub-micrometer). This paper describes an interlaboratory comparison with the goal of assessing the measurement variability for the characterization of a sub-micrometer polydisperse par...
Leaching of toxic or reactive chemicals from polymeric materials can adversely affect the quality and safety of biopharmaceuticals.
It was therefore the aim of the present study to analyze leachables from a disposable clinical administration syringe using a polysorbate-containing surrogate solution and to assess their chemical reactivity.
Analytica...
Intravitreal (IVT) injection is currently the state of the art for drug delivery to the back of the eye. Drug Products (DP) intended for IVT injections usually pose challenges such as a very low injection volume (e.g. 50 μL) and high injection forces. DPs in vials are typically transferred and injected using disposable polymer syringes, which can f...
PurposeHealth care professionals can be exposed to hazardous drugs such as cytostatics during preparation of drugs for administration. Closed sytem transfer devices (CSTDs) were introduced to provide protection for healthcare professional against unintended exposure to hazardous drugs. The interest in CSTDs has significantly increased after USP <80...
Glass fogging is a phenomenon occurring in lyophilized drug products and can be described as a thin product layer deposited on the inner surface of the glass container, in the area not covered by the lyo cake itself. It is often considered a cosmetic defect; however, the loss of container closure integrity is a potential consequence of the fogging'...
Physical tablet defects are related to internal structural defects that are not easily assessed by the traditional methods, such as dusting, laminating, or fracturing during appearance, friability, or hardness testing. Also, these methods do not allow objective and quantitative investigation of the role of formulation and process variables, which i...
The study aimed to characterise the mechanism of release and absorption of Basmisanil, a biopharmaceutics classification system (BCS) class 2 compound, from immediate-release formulations via mechanistic absorption modelling, dissolution testing, and Raman imaging. An oral absorption model was developed in GastroPlus® and verified with single-dose...
We derive a simple first order kinetics model for the powder mixing in a bin blender and adapt it to fit the NIR spectra obtained during the real-time mixing. The model is tested on a full drug product formulation mixing consisting of API and multiple excipients. It allows to extract a quantitative mixing rate for individual ingredients, which may...
Unlabelled:
Container closure integrity (CCI) testing is required by different regulatory authorities in order to provide assurance of tightness of the container closure system against possible contamination, for example, by microorganisms. Microbial ingress CCI testing is performed by incubation of the container closure system with microorganisms...
The distinction of natural from cultured pearls traditionally has been based on X-radiography. X-ray computed microtomography (μ-CT) has recently been applied to gain more insight into pearl structures. Using this technique, this article presents features observed in a selection of natural pearls and beaded and non-beaded cultured pearls. Based on...
Near-infrared spectroscopy (NIRS) is a fast and non-destructive analytical method. Associated with chemometrics, it becomes a powerful tool for the pharmaceutical industry. Indeed, NIRS is suitable for analysis of solid, liquid and biotechnological pharmaceutical forms. Moreover, NIRS can be implemented during pharmaceutical development, in product...
The pharmaceutical industry faces increasing regulatory pressure to optimize quality control. Content uniformity is a basic release test for solid dosage forms. To accelerate test throughput and comply with the Food and Drug Administration's process analytical technology initiative, attention is increasingly turning to nondestructive spectroscopic...
Near-infrared spectroscopy (NIRS) has become a widely used analytical technique in the pharmaceutical industry, serving for example to determine the active substance or water content of tablets. Its great advantage lies in the minimal sample preparation required and speed of measurement. In a study designed to detect the effects of process on table...
Near-infrared (NIR) spectroscopy can be applied to determine the active substance content of tablets. Its great advantage lies in the minimal sample preparation required, which helps to reduce the potential for error. The aim of this study is to show the feasibility of this method on low-dosage tablets. The influence of various spectral pretreatmen...
A multi-spectral imaging spectrometer records simultaneously spectra and spatial information of samples. The infrared (IR) imaging system used was the Hyperion 3000 microscope (Bruker Optics) equipped with a focal plane array (FPA) detector. The detector allows creating a 64 × 64 pixels image. For each pixel, a complete spectrum is acquired, which...
