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 interpl...
The good manufacturing practices (GMP) and process analytical technology (PAT) initiatives of the US Food and Drug Administration, in conjunction with International Council for Harmonisation (ICH) quality guidelines Q8, Q9, and Q10, ensure that manuf...
Lyophilization is widely used in the preservation of thermolabile products. The main shortcoming is the long processing time. Lyophilization processes are mostly based on a recipe that is not changed, but, with the Quality by Design (QbD) approach an...
Productivity improvements of mammalian cell culture in the production of recombinant proteins have been made by optimizing cell lines, media, and process operation. This led to enhanced titers and process robustness without increasing the cost of the...
Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that...
Continuous manufacturing opens up new operation windows with improved product quality in contrast to documented lot deviations in batch or fed-batch operations. A more sophisticated process control strategy is needed to adjust operation parameters an...
The integration of real time release testing into an advanced process control (APC) concept in combination with digital twins accelerates the process towards autonomous operation. In order to implement this, on the one hand, measurement technology is...
This study explores how new communication technology is implemented in education by mainly focusing on the teacher’s role. With a questionnaire and interview surveys, the analytic hierarchy process (AHP) was carried out to understand the factors that...
Yellow Fever (YF) is a severe disease that, while preventable through vaccination, lacks rapid intervention options for those already infected. There is an urgent need for passive immunization techniques using YF-virus-like particles (YF-VLPs). To ad...
Sr(OH)2 is an indispensable strontium compound extensively harnessed in sugar refining, strontium lubricating wax formulation, and polymer plastic stabilization. Sr(OH)2·8H2O is the prevalent hydrate form of Sr(OH)2. Deprived of moisture via v...
This study used a technology–organization–environment (TOE) framework as the primary analytical tool to explore the burgeoning capabilities of blockchain technology in the area of 5G ceramic antenna development. A causal loop diagram (CLD...
Control strategy and quality by design (QbD) are widely used to develop pharmaceutical products and improve drug quality; however, studies on fixed-dose combination (FDC) bilayer tablets are limited. In this study, the bilayer tablet consisted of hig...
This study addresses the critical issue of cardiovascular diseases (CVDs) as the leading cause of death globally, emphasizing the importance of stent delivery catheter manufacturing. Traditional manufacturing processes, reliant on destructive end-of-...
Most countries face declining birth rates and an aging population, which makes the persistent healthcare labor shortage a pressing challenge. Introducing artificial intelligence (AI) robots into home healthcare could help address these issues. Explor...
Background: Active pharmaceutical ingredient (API) content is a critical quality attribute (CQA) of amorphous solid dispersions (ASDs) prepared by spraying a solution of APIs and polymers onto the excipients in fluid bed granulator. This study presen...
In the context of healthcare technology management (HTM) in Saudi Arabia and the Gulf region, this study addresses a significant gap by exploring both external and internal risk factors affecting HTM performance. Previous studies have primarily focus...
The demand for smart irrigation and water-saving practices in agriculture has triggered the development of different soil moisture sensing techniques that can operate under harsh field conditions. In this study, a soil moisture sensing technology app...
Prisons are the structures used for incarcerated inmates and are often overcrowded and understaffed. This often leads to inhumane conditions and increased violence. Smart building technologies can help to alleviate these problems to some extent and i...
The aim of this study was to study the impact of artificial intelligence (AI) on enterprises in terms of strategy, technology, business operations, and organizational management. This study used grounded theory analysis to identify the influencing fa...
This paper displays the potential of an in-line PAT system for early phase product development during pharmaceutical continuous manufacturing following a Quality by Design (QbD) framework. Hot melt extrusion (HME) is used as continuous manufacturing...
The European Commission as well as the Polish government are promoting sustainable use of energy sources as a part of the dominating sustainable development paradigm. The development of low-emission energy sources engages the challenges of gradual de...
Sewage sludge management has gained significance in the last several years, due to its nutrient and energy content. However, technology selection is one of the greater challenges because it is not possible to implement a technology that covers all th...
Water shortage is one of the most crucial challenges worldwide, especially in the Middle Eastern countries, with high population and low freshwater resources. Considering this point and the increasing popularity of solar stills desalination systems,...
Viral vectors and viral vaccines are invaluable tools in prevention and treatment of diseases. Many infectious diseases are controlled using vaccines designed from subunits or whole viral structures, whereas other genetic diseases and cancers are bei...
The study proposes a process analytical technology (PAT) approach for the control of milk coagulation through near infrared spectroscopy (NIRS), computing multivariate statistical process control (MSPC) charts, based on principal component analysis (...
By employing the analytic hierarchy process (AHP), we investigated consumer demand and preferences for InsurTech technologies. A survey was conducted with 350 respondents, yielding 348 completed questionnaires and achieving a response rate of 99.4%....
Continuous flow reactors (CFRs) are an emerging technology that offer several advantages over traditional batch synthesis methods, including more efficient mixing schemes, rapid heat transfer, and increased user safety. Of particular interest to the...
Failures in milk coagulation during cheese manufacturing can lead to decreased yield, anomalous behaviour of cheese during storage, significant impact on cheese quality and process wastes. This study proposes a Process Analytical Technology approach...
Liquid–liquid extraction has proven to be an aid in biologics manufacturing for cell and component separation. Because distribution coefficients and separation factors can be appropriately adjusted via phase screening, especially in aqueous two...
Despite great efforts to develop a vaccine against human immunodeficiency virus (HIV), which causes AIDS if untreated, no approved HIV vaccine is available to date. A promising class of vaccines are virus-like particles (VLPs), which were shown to be...
For the first time, a universally applicable and methodical approach from characterization to a PAT concept for complex mixtures is conducted—exemplified on natural products extraction processes. Bearberry leaf (Arctostaphylos uva-ursi) extract...
Background: Metastable zone width (MSZW) and solubility are crucial for developing crystallization procedures in the purification of active pharmaceutical ingredients (APIs). Traditionally, determining these properties involves labor-intensive method...
Hydrodistillation is traditionally a green technology for the manufacturing of natural products that are volatile. As well as acknowledged process intensification methods such as microwave support for energy efficiency to move towards climate neutral...
Herbal remedies are in most cases still manufactured with traditional equipment installations and processes. Innovative chemical process engineering methods such as modeling and process intensification with green technology could contribute to the ec...
Pharmaceutical manufacturing processes are moving towards automation and real-time process monitoring with the help of process analytical technologies (PATs) and predictive process models representing the real system. In this paper, we present a digi...
In the last few decades, hot-melt extrusion (HME) has emerged as a rapidly growing technology in the pharmaceutical industry, due to its various advantages over other fabrication routes for drug delivery systems. After the introduction of the ‘qualit...
Twin-screw wet granulation (TSWG) is a method of continuous pharmaceutical manufacturing and a potential alternative method to batch granulation processes. It has attracted more and more interest nowadays due to its high efficiency, robustness, and a...
In the past 30 years, highly specific drugs, known as antibodies, have conquered the biopharmaceutical market. In addition to monoclonal antibodies (mAbs), antibody fragments are successfully applied. However, recombinant production faces challenges....
Characterized by its resilience, connectivity, and real-time data processing capabilities, the fourth industrial revolution, referred to as Industry 4.0, is the main driver of today’s digital transformation. It is crucially important for manufa...
Lyophilization is a widely used drying operation, but long processing times are a major drawback. Most lyophilization processes are conducted by a recipe that is not changed or optimized after implementation. With the regulatory demanded quality by d...
Continuous processing offers many advantages in pharmaceutical manufacturing. [...]
SARS-COVID-19 vaccine supply for the total worldwide population has a bottleneck in manufacturing capacity. Assessment of existing messenger ribonucleic acid (mRNA) vaccine processing shows a need for digital twins enabled by process analytical techn...
Digital twins have emerged as a powerful concept for real-time monitoring and analysis, facilitating Quality by Design integration into biopharmaceutical manufacturing. Traditionally, lyophilization processes are developed through trial-and-error, in...
Poor access to clean and reliable energy technologies is a major challenge to most developing countries. The decision to introduce new technologies is often faced by low adoption rates or even public opposition. In addition, the data required for eff...
Supplying SARS-COVID-19 vaccines in quantities to meet global demand has a bottleneck in manufacturing capacity. Assessment of existing mRNA (messenger ribonucleic acid) vaccine processing shows the need for digital twins enabled by process analytica...
Upgrading the Syrian refugee shelter design serves humanitarian needs, especially since the currently used T-shelters have a life span of 2–4 years, and there are no clear signs of an imminent return of Syrian refugees to their country, even af...
With the increasing need for energy, issues related to using energy efficiently in buildings and employing renewable energy technologies are gaining significance. The building production process is intricate, involving numerous stakeholders, multiple...
The development and adoption of digital twins (DT) for Quality-by-Design (QbD)-based processes with flexible operating points within a proven acceptable range (PAR) and automation through Advanced Process Control (APC) with Process Analytical Technol...
Raman spectroscopy is an analytical technology for the simultaneous measurement of important process parameters, such as concentrations of nutrients, metabolites, and product titer in mammalian cell culture. The majority of published Raman studies ha...
In order to evaluate ecological technology scientifically, we constructed a modular “three-stage evaluation method” based on qualitative evaluation, semiquantitative evaluation and quantitative evaluation, and established the theoretical...
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