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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: 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: 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: The PARP inhibitor rucaparib blocks SARS‐CoV‐2 virus binding to cells and the immune reaction in models of COVID‐19
The PARP inhibitor rucaparib blocks SARS‐CoV‐2 virus binding to cells and the immune reaction in models of COVID‐19 Open
Background and Purpose To date, there are limited options for severe Coronavirus disease 2019 (COVID‐19), caused by SARS‐CoV‐2 virus. As ADP‐ribosylation events are involved in regulating the life cycle of coronaviruses and the inflammator…
View article: SARS-CoV-2 Nucleocapsid Protein Is Not Responsible for Over-Activation of Complement Lectin Pathway
SARS-CoV-2 Nucleocapsid Protein Is Not Responsible for Over-Activation of Complement Lectin Pathway Open
The nucleocapsid (N) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a viral structural protein that is abundant in the circulation of infected individuals. Previous published studies reported controversial data …
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: 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: Application of a Receptor-Binding-Domain-Based Simple Immunoassay for Assessing Humoral Immunity against Emerging SARS-CoV-2 Virus Variants
Application of a Receptor-Binding-Domain-Based Simple Immunoassay for Assessing Humoral Immunity against Emerging SARS-CoV-2 Virus Variants Open
We have developed a simple, rapid, high-throughput RBD-based ELISA to assess the humoral immunity against emerging SARS-CoV-2 virus variants. The cDNAs of the His-tagged RBD proteins of the virus variants were stably engineered into HEK ce…
View article: Application of an Rbd-Based Simple Immunoassay for Assessing Humoral Immunity against Emerging SARS-CoV-2 Virus Variants
Application of an Rbd-Based Simple Immunoassay for Assessing Humoral Immunity against Emerging SARS-CoV-2 Virus Variants Open
We have developed a simple, rapid, high-throughput RBD-based ELISA to assess the humoral immunity against emerging SARS-CoV-2 virus variants. The cDNAs of the his-tagged RBD proteins of the virus variants were stably engineered into HEK ce…
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: Oligonucleotide Formulations Prepared by High-Speed Electrospinning: Maximizing Loading and Exploring Downstream Processability
Oligonucleotide Formulations Prepared by High-Speed Electrospinning: Maximizing Loading and Exploring Downstream Processability Open
The aim of this study was to develop antisense oligonucleotide tablet formulations using high-speed electrospinning. Hydroxypropyl-beta-cyclodextrin (HPβCD) was used as a stabilizer and as an electrospinning matrix. In order to optimize th…
View article: Challenges and Opportunities of Implementing Data Fusion in Process Analytical Technology—A Review
Challenges and Opportunities of Implementing Data Fusion in Process Analytical Technology—A Review Open
The release of the FDA’s guidance on Process Analytical Technology has motivated and supported the pharmaceutical industry to deliver consistent quality medicine by acquiring a deeper understanding of the product performance and process in…
View article: Rucaparib blocks SARS-CoV-2 virus binding to cells and interleukin-6 release in a model of COVID-19
Rucaparib blocks SARS-CoV-2 virus binding to cells and interleukin-6 release in a model of COVID-19 Open
Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2 virus, is a major global health challenge, as there is no efficient treatment for the moderate to severe disease. ADP-ribosylation events are involved in regulating the life cycle o…
View article: Real‐time amino acid and glucose monitoring system for the automatic control of nutrient feeding in CHO cell culture using Raman spectroscopy
Real‐time amino acid and glucose monitoring system for the automatic control of nutrient feeding in CHO cell culture using Raman spectroscopy Open
An innovative, Raman spectroscopy‐based monitoring and control system is introduced in this paper for designing dynamic feeding strategies that allow the maintenance of key cellular nutrients at an ideal level in Chinese hamster ovary cell…
View article: Continuous downstream processing of milled electrospun fibers to tablets monitored by near-infrared and Raman spectroscopy
Continuous downstream processing of milled electrospun fibers to tablets monitored by near-infrared and Raman spectroscopy Open
Electrospinning is a technology for manufacture of nano- and micro-sized fibers, which can enhance the dissolution properties of poorly water-soluble drugs. Tableting of electrospun fibers have been demonstrated in several studies, however…
View article: Probiotic bacteria stabilized in orally dissolving nanofibers prepared by high-speed electrospinning
Probiotic bacteria stabilized in orally dissolving nanofibers prepared by high-speed electrospinning Open
To utilize the effect of probiotics in the oral cavity, an easily applicable, orally dissolving dosage form of Lactobacillus paracasei was prepared by high-speed electrospinning. The scaled-up electrostatic drying technology resulted in hi…
View article: Comparison of Amorphous Solid Dispersions of Spironolactone Prepared by Spray Drying and Electrospinning: The Influence of the Preparation Method on the Dissolution Properties
Comparison of Amorphous Solid Dispersions of Spironolactone Prepared by Spray Drying and Electrospinning: The Influence of the Preparation Method on the Dissolution Properties Open
This research aimed to compare two solvent-based methods for the preparation of amorphous solid dispersions (ASDs) made up of poorly soluble spironolactone and poly(vinylpyrrolidone-co-vinyl acetate). The same apparatus was used to produce…
View article: Monoclonal antibody formulation manufactured by high-speed electrospinning
Monoclonal antibody formulation manufactured by high-speed electrospinning Open
Solid formulations of monoclonal antibodies present several advantages, such as improved stability and increased shelf-life as well as simpler storage and transportation. In this study, we present a gentle drying technology for monoclonal …
View article: Electrospun Solid Formulation of Anaerobic Gut Microbiome Bacteria
Electrospun Solid Formulation of Anaerobic Gut Microbiome Bacteria Open
A model anaerobic bacterium strain from the gut microbiome ( Clostridium butyricum ) producing anti-inflammatory molecules was incorporated into polymer-free fibers of a water-soluble cyclodextrin matrix (HP-β-CD) using a promising scaled-…
View article: <scp>Raman‐based</scp> dynamic feeding strategies using real‐time glucose concentration monitoring system during adalimumab producing <scp>CHO</scp> cell cultivation
<span>Raman‐based</span> dynamic feeding strategies using real‐time glucose concentration monitoring system during adalimumab producing <span>CHO</span> cell cultivation Open
The use of Process Analytical Technology tools coupled with chemometrics has been shown great potential for better understanding and control of mammalian cell cultivations through real‐time process monitoring. In‐line Raman spectroscopy wa…
View article: A solid doxycycline HP-β-CD formulation for reconstitution (i.v. bolus) prepared by scaled-up electrospinning
A solid doxycycline HP-β-CD formulation for reconstitution (i.v. bolus) prepared by scaled-up electrospinning Open
In this study a new intravenous (i.v.) bolus dosage form of doxycycline was prepared by electrospinning. A tetracycline-type antibiotic with low water solubility (doxycycline (DOX)) was used with 2-hydroxypropyl-β-cyclodextrin (HP-β-CD) as…
View article: Scale‐up of electrospinning technology: Applications in the pharmaceutical industry
Scale‐up of electrospinning technology: Applications in the pharmaceutical industry Open
Recently, electrospinning (ES) of fibers has been shown to be an attractive strategy for drug delivery. One of the main features of ES is that a wide variety of drugs can be loaded into the fibers to improve their bioavailability, to enhan…
View article: Continuous Formulation Approaches of Amorphous Solid Dispersions: Significance of Powder Flow Properties and Feeding Performance
Continuous Formulation Approaches of Amorphous Solid Dispersions: Significance of Powder Flow Properties and Feeding Performance Open
Preparation and formulation of amorphous solid dispersions (ASDs) are becoming more and more popular in the pharmaceutical field because the dissolution of poorly water-soluble drugs can be effectively improved this way, which can lead to …
View article: Scaled-Up Production and Tableting of Grindable Electrospun Fibers Containing a Protein-Type Drug
Scaled-Up Production and Tableting of Grindable Electrospun Fibers Containing a Protein-Type Drug Open
The aims of this work were to develop a processable, electrospun formulation of a model biopharmaceutical drug, β-galactosidase, and to demonstrate that higher production rates of biopharmaceutical-containing fibers can be achieved by usin…
View article: Inline noninvasive Raman monitoring and feedback control of glucose concentration during ethanol fermentation
Inline noninvasive Raman monitoring and feedback control of glucose concentration during ethanol fermentation Open
Raman spectroscopy as a process analytical technology tool was implemented for the monitoring and control of ethanol fermentation carried out with Saccharomyces cerevisiae . The need for the optimization of bioprocesses such as ethanol pro…
View article: Continuous alternative to freeze drying: Manufacturing of cyclodextrin-based reconstitution powder from aqueous solution using scaled-up electrospinning
Continuous alternative to freeze drying: Manufacturing of cyclodextrin-based reconstitution powder from aqueous solution using scaled-up electrospinning Open
The aims of this study were to evaluate electrospinning as a continuous alternative to freeze drying in the production of a reconstitution injection dosage form, and to prove that aqueous electrospinning can be realized with a high product…
View article: Electrospinning scale-up and formulation development of PVA nanofibers aiming oral delivery of biopharmaceuticals
Electrospinning scale-up and formulation development of PVA nanofibers aiming oral delivery of biopharmaceuticals Open
Electrospinning is a promising drying technology providing a rapid and gentle drying at ambient temperature, thus electrospinning of polyvinyl alcohol aqueous solutions was investigated for the solid formulation of biopharmaceuticals. The …
View article: Pharmaceutical and Macromolecular Technologies in the Spirit of Industry 4.0
Pharmaceutical and Macromolecular Technologies in the Spirit of Industry 4.0 Open
Well designed (multilayer, adaptive, reactive) interphases, being a key element of multicomponent structures, could be tailored to different requirements through controlled technologies. This is the link connecting various green, safe, hea…