Zsombor Kristóf Nagy
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View article: Characterization of digital camera-based UV illumination fluorescent imaging for concentration measurement with limit of detection, specificity and precision
Characterization of digital camera-based UV illumination fluorescent imaging for concentration measurement with limit of detection, specificity and precision Open
Nowadays the increased need for pharmaceutics requires fast, cheap and reliable quality control systems to investigate the final product's quality. The generally used methods like high-pressure liquid chromatography (HPLC) and other couple…
View article: Real-time component-based particle size measurement and dissolution prediction during continuous powder feeding using machine vision and artificial intelligence-based object detection
Real-time component-based particle size measurement and dissolution prediction during continuous powder feeding using machine vision and artificial intelligence-based object detection Open
This work presents a system, in which machine vision combined with artificial intelligence-based image analysis was used to determine the component-based particle size distribution of pharmaceutical powder blends. The blends consisted of a…
View article: Artificial intelligence-aided endoscopic in-line particle size analysis during the pellet layering process
Artificial intelligence-aided endoscopic in-line particle size analysis during the pellet layering process Open
In this study, an artificial intelligence-based machine vision system was developed for in-line particle size analysis during the pellet layering process. Drug-layered pellets were produced by coating microcrystalline cellulose cores with …
View article: Stabilizing effect of HP-β-CD on infliximab in liquid formulations and a solid formulation produced by electrospinning
Stabilizing effect of HP-β-CD on infliximab in liquid formulations and a solid formulation produced by electrospinning Open
The development of stable biopharmaceutical formulations, such as monoclonal antibodies, poses a great challenge in the pharmaceutical industry. This study investigated the stabilizing effect of 2-hydroxypropyl-β-cyclodextrin (HP-β-CD) in …
View article: The current state-of-the art in pharmaceutical continuous film coating – A review
The current state-of-the art in pharmaceutical continuous film coating – A review Open
In this decade, one of the major trends in the pharmaceutical industry is the adoption of continuous manufacturing. This requires the development of continuous equivalents of essential pharmaceutical processes such as film coating. The pro…
View article: Continuous twin-screw melt granulation of drug-loaded electrospun fibers
Continuous twin-screw melt granulation of drug-loaded electrospun fibers Open
Electrospinning (ES) is a promising continuous formulation strategy to produce amorphous solid dispersions (ASDs) and thereby improve the dissolution of poorly water-soluble drugs. However, processing the electrospun material into solid do…
View article: Automated tablet defect detection and the prediction of disintegration time and crushing strength with deep learning based on tablet surface images
Automated tablet defect detection and the prediction of disintegration time and crushing strength with deep learning based on tablet surface images Open
This paper presents novel measurement methods, where deep learning was used to detect tableting defects and determine the crushing strength and disintegration time of tablets on images captured by machine vision. Five different classes of …
View article: Process analytical technology based quality assurance of API concentration and fiber diameter of electrospun amorphous solid dispersions
Process analytical technology based quality assurance of API concentration and fiber diameter of electrospun amorphous solid dispersions Open
In this study, a novel quality assurance system was developed utilizing Process analytical technology (PAT) tools and artificial intelligence (AI). Our goal was to monitor the critical quality attributes (CQAs) like drug concentration, mor…
View article: Development and integration of a continuous horizontal belt filter into drug production procedure
Development and integration of a continuous horizontal belt filter into drug production procedure Open
In the pharmaceutical industry, filtration is traditionally carried out in batch mode. However, with the spread of continuous technologies, there is an increasing demand for robust continuous filtration strategies suitable for processing s…
View article: Evaluation of floatability characteristics of gastroretentive tablets using VIS imaging with artificial neural networks
Evaluation of floatability characteristics of gastroretentive tablets using VIS imaging with artificial neural networks Open
Gastroretentive dosage forms are recommended for several active substances because it is often necessary for the drug to be released from the carrier system into the stomach over an extended period. Among gastroretentive dosage forms, floa…
View article: In-line indirect concentration measurement of ultralow dose API during twin-screw wet granulation based on NIR and Raman spectroscopy
In-line indirect concentration measurement of ultralow dose API during twin-screw wet granulation based on NIR and Raman spectroscopy Open
Twin-screw wet granulation (TWSG) is a promising continuous alternative of pharmaceutical wet granulation. One of its benefits is that the components dissolved in the granulation liquid are distributed homogeneously in the granules. This p…
View article: UV/VIS-imaging of white caffeine tablets for prediction of CQAs: API content, crushing strength, friability, disintegration time and dissolution profile
UV/VIS-imaging of white caffeine tablets for prediction of CQAs: API content, crushing strength, friability, disintegration time and dissolution profile Open
The paper provides a demonstration of how UV/VIS imaging can be employed to evaluate the crushing strength, friability, disintegration time and dissolution profile of tablets comprised of solely white components. The samples were produced …
View article: Explainable deep recurrent neural networks for the batch analysis of a pharmaceutical tableting process in the spirit of Pharma 4.0
Explainable deep recurrent neural networks for the batch analysis of a pharmaceutical tableting process in the spirit of Pharma 4.0 Open
Due to the continuously increasing Cost of Goods Sold, the pharmaceutical industry has faced several challenges, and the Right First-Time principle with data-driven decision-making has become more pressing to sustain competitiveness. Thus,…
View article: Thermal investigation of relaxations of interacting and non-interacting amorphous solid dispersions
Thermal investigation of relaxations of interacting and non-interacting amorphous solid dispersions Open
In the present research, thermal investigation of amorphous solid dispersions (ASDs) was performed in order to compare their relaxation transitions. Two different active pharmaceutical ingredients (APIs), namely naproxen (NAP) and spironol…
View article: Real-time release testing of in vitro dissolution and blend uniformity in a continuous powder blending process by NIR spectroscopy and machine vision
Real-time release testing of in vitro dissolution and blend uniformity in a continuous powder blending process by NIR spectroscopy and machine vision Open
Continuous manufacturing is gaining increasing interest in the pharmaceutical industry, also requiring real-time and non-destructive quality monitoring. Multiple studies have already addressed the possibility of surrogate in vitro dissolut…
View article: Raman and NIR spectroscopy-based real-time monitoring of the membrane filtration process of a recombinant protein for the diagnosis of SARS-CoV-2
Raman and NIR spectroscopy-based real-time monitoring of the membrane filtration process of a recombinant protein for the diagnosis of SARS-CoV-2 Open
This research shows the detailed comparison of Raman and near-infrared (NIR) spectroscopy as Process Analytical Technology tools for the real-time monitoring of a protein purification process. A comprehensive investigation of the applicati…
View article: UV imaging for the rapid at-line content determination of different colourless APIs in their tablets with artificial neural networks
UV imaging for the rapid at-line content determination of different colourless APIs in their tablets with artificial neural networks Open
This paper presents a novel high-resolution and rapid (50 ms) UV imaging system, which was used for at-line, non-destructive API content determination of tablets. For the experiments, amlodipine and valsartan were selected as two colourles…
View article: Machine vision-based non-destructive dissolution prediction of meloxicam-containing tablets
Machine vision-based non-destructive dissolution prediction of meloxicam-containing tablets Open
Machine vision systems have emerged for quality assessment of solid dosage forms in the pharmaceutical industry. These can offer a versatile tool for continuous manufacturing while supporting the framework of process analytical technology,…
View article: UV–VIS imaging-based investigation of API concentration fluctuation caused by the sticking behaviour of pharmaceutical powder blends
UV–VIS imaging-based investigation of API concentration fluctuation caused by the sticking behaviour of pharmaceutical powder blends Open
Surface powder sticking in pharmaceutical mixing vessels poses a risk to the uniformity and quality of drug formulations. This study explores methods for evaluating the amount of pharmaceutical powder mixtures adhering to the metallic surf…
View article: Effects of omitting titanium dioxide from the film coating of a pharmaceutical tablet – An industrial case study of attempting to comply with EU regulation 2022/63
Effects of omitting titanium dioxide from the film coating of a pharmaceutical tablet – An industrial case study of attempting to comply with EU regulation 2022/63 Open
Recently, concerns have been raised about the safety of titanium dioxide (TiO2), a commonly used component of pharmaceutical film coatings. The European Union has recently prohibited the application of this material in the food industry, a…
View article: Quantitative and qualitative analysis of cell culture media powders for mammalian cells by Raman microscopy
Quantitative and qualitative analysis of cell culture media powders for mammalian cells by Raman microscopy Open
Cell culture media are essential for large-scale recombinant protein production using mammalian cell cultures. The composition and quality of media significantly impact cell growth and product formation. Analyzing media poses challenges du…
View article: Development of a PAT platform for the prediction of granule tableting properties
Development of a PAT platform for the prediction of granule tableting properties Open
In this work, the feasibility of implementing a process analytical technology (PAT) platform consisting of Near Infrared Spectroscopy (NIR) and particle size distribution (PSD) analysis was evaluated for the prediction of granule downstrea…
View article: Image-based simultaneous particle size distribution and concentration measurement of powder blend components with deep learning and machine vision
Image-based simultaneous particle size distribution and concentration measurement of powder blend components with deep learning and machine vision Open
This work presents a system, where deep learning was used on images captured with a digital camera to simultaneously determine the API concentration and the particle size distribution (PSD) of two components of a powder blend. The blend co…
View article: Comparing the Performance of Raman and Near-Infrared Imaging in the Prediction of the In Vitro Dissolution Profile of Extended-Release Tablets Based on Artificial Neural Networks
Comparing the Performance of Raman and Near-Infrared Imaging in the Prediction of the In Vitro Dissolution Profile of Extended-Release Tablets Based on Artificial Neural Networks Open
In this work, the performance of two fast chemical imaging techniques, Raman and near-infrared (NIR) imaging is compared by utilizing these methods to predict the rate of drug release from sustained-release tablets. Sustained release is pr…
View article: In-line particle size measurement during granule fluidization using convolutional neural network-aided process imaging
In-line particle size measurement during granule fluidization using convolutional neural network-aided process imaging Open
This paper presents a machine learning-based image analysis method to monitor the particle size distribution of fluidized granules. The key components of the direct imaging system are a rigid fiber-optic endoscope, a light source and a hig…
View article: Development and Comparison of Alternative Methods for the Purification of Adalimumab Directly from Harvested Cell Culture Fluid
Development and Comparison of Alternative Methods for the Purification of Adalimumab Directly from Harvested Cell Culture Fluid Open
Research background. Protein A affinity chromatography is a well-established method currently used in the pharmaceutical industry. However, the high costs usually associated with chromatographic separation of protein A and the difficulties…
View article: Droplet Based Estimation of Viscosity of Water–PVP Solutions Using Convolutional Neural Networks
Droplet Based Estimation of Viscosity of Water–PVP Solutions Using Convolutional Neural Networks Open
The viscosity of a liquid is the property that measures the liquid’s internal resistance to flow. Monitoring viscosity is a vital component of quality control in several industrial fields, including chemical, pharmaceutical, food, and ener…
View article: Integrated continuous melt granulation-based powder-to-tablet line: Process investigation and scale-up on the same equipment
Integrated continuous melt granulation-based powder-to-tablet line: Process investigation and scale-up on the same equipment Open
In the last decades, continuous manufacturing (CM) has become a research priority in the pharmaceutical industry. However, significantly fewer scientific researches address the investigation of integrated, continuous systems, a field that …
View article: AI-based analysis of in-line process endoscope images for real-time particle size measurement in a continuous pharmaceutical milling process
AI-based analysis of in-line process endoscope images for real-time particle size measurement in a continuous pharmaceutical milling process Open
This paper presents a case study on the first in-line application of AI-based image analysis for real-time pharmaceutical particle size measurement in a continuous milling process. An AI-based imaging system, which utilises a rigid endosco…