In this work, the manufacturing, characterization, and optical testing of phase diffraction gratings is performed. The fabrication is carried out in a very simple way: by immersion of a common ...amplitude diffraction gratings on acid and a posterior chemical procedure. The process makes it achievable for almost any scientist, since expensive equipment is not required. We have tested three different acids and evaluated the engraving depth (phase retardation) in terms of the immersion time. With this analysis, phase diffraction gratings with the desired phase delay could be manufactured. The quality of the gratings has been evaluated by means of their profiles and histograms of the surface, using confocal microscopy. To conclude, we have measured the near-field behavior of one of the phase gratings and compared it with that obtained analytically, showing high agreement.
Development of oncolytic virotherapy for cancer treatment is attracting great concerns as a next-generation innovative modality. Oncolytic virotherapy usually utilize genetically modified virus that ...is designed to multiply only in cancer cells for safety. Conducting clinical trials as well as pre-clinical studies requires large quantities of high quality viruses as to GMP. Here we present the key considerations regarding GMP compliant process development of manufacturing oncolytic virus, Coxsackie virus type B3 (CVB3), designed for clinical trial targeting triple-negative breast cancer. CVB3 is a non-enveloped, linear single-strand RNA virus, and sizing approximately 27 to 33 nm diameter.
Here we will discuss the key considerations we have gained during the manufacturing process development from the initial model using a zonal rotor centrifugal separator to the later developed systems including tangential flow filtration system and ion chromatography. Later developed system consists of all process, from upstream cell culture expansion to downstream target purification, being designed as fully closed and single-use manufacturing system. In brief, HEK293 cell suspension extended in 3L serum-free medium infected with CVB3, made total 150 mL of final products as 8.43 x 10 exp7 TCID50/mL concentration. Quality analysis of products related impurities as residual human cell protein and remnant DNA/RNA was also confirmed to be within FDA recommended standards. Thus the GMP compliant manufacturing process of oncolytic virus we established considered to be suitable for technology transfer for future commercial production.
Active pharmaceutical ingredients (APIs) are most commonly formulated and delivered to patients in the solid state. Recently, an alternative API solid-state form, namely the pharmaceutical cocrystal, ...has witnessed increasing academic and industrial interest due to its potential to deliver bespoke physical properties in the pharmaceutical drug product. This interest has been supported by advances in cocrystal discovery, development, and approval, enabled primarily by a supportive new FDA guidance in February 2018. In this review, we describe the process of developing a pharmaceutical cocrystal drug product from screening to approval, with an emphasis on significant developments over the past decade.
Cocrystallization is a promising emerging option to improve the physicochemical solid-state properties of APIs, such as solubility, dissolution rate, stability, and tabletability, to develop better medicines.
Cocrystals provide a unique opportunity for challenging APIs to make the transition to commercial drug products with relatively low risk and high return on investment.
Cocrystals have been researched over the past few decades, yet only a few cocrystals products are commercially available.
Manufacture of cocrystals has been demonstrated through established pharmaceutical industry processes (solution crystallization) and novel alternative methods (mechanochemical approaches).
The latest FDA draft guidance on cocrystals, which recognizes cocrystals as drug substances, provides an excellent opportunity for drug manufacturers to develop commercial formulations of cocrystals.
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Due to the technological advances, sensors have found a significant role in different aspects of human life. The sensors have been fabricated via various manufacturing processes. ...Recently, additive manufacturing (AM) has become a common method for fabrication of a wide range of engineering components in many industries. This manufacturing method, commonly known as three-dimensional (3D) printing is based on melting and solidification that leads to production of a component with high dimensional accuracy and smooth surface finish. As precision and elegant techniques are needed in manufacturing of the sensors, AM has been utilized in fabrication of these parts in the last few years. In this study, we summarized and classified applications of different AM methods in manufacturing of sensors. In this context, we briefly reviewed and compared AM techniques and categorized 3D-printed sensors based on their applications. Moreover, fabrication of sensors via AM is explained in details, challenges and future prospect of this manufacturing process are discussed. Investigations on the performed studies proved that higher printing resolution, faster speed and higher efficiency are needed to reach a remarkable advance in the production of 3D-printed sensors. The presented data can be utilized not only for comparison, improvement and optimization of fabrication processes, but also is beneficial for next research in production of highly sensitive sensors.
Heavy metals are widely distributed in the environment due to the natural processes and anthropogenic human activities. Their migration into no contaminated areas contributing towards pollution of ...the ecosystems e.g. soils, plants, water and air. It is recognized that heavy metals due to their toxicity, long persistence in nature can accumulate in the trophic chain and cause organism dysfunction. Although the popularity of herbal medicine is rapidly increasing all over the world heavy metal toxicity has a great impact and importance on herbal plants and consequently affects the quality of herbal raw materials, herbal extracts, the safety and marketability of drugs. Effective control of heavy metal content in herbal plants using in pharmaceutical and food industries has become indispensable. Therefore, this review describes various important factors such as ecological and environmental pollution, cultivation and harvest of herbal plants and manufacturing processes which effects on the quality of herbal plants and then on Chinese herbal medicines which influence human health. This review also proposes possible management strategies to recover environmental sustainability and medication safety. About 276 published studies (1988–2021) are reviewed in this paper.
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•Medicinal crops suffer with multi-source heavy metals have potential security risks.•Chinese herbal medicine faces security issues related to heavy metals.•Relationship between heavy metals and Chinese herbal medicine is evident.
Quality prediction, as the basis of quality control, is dedicated to predicting quality indices of the manufacturing process. In recent years, data-driven deep learning methods have received a lot of ...attention due to their accuracy, robustness, and convenience for the prediction of quality indices. However, the existing studies mainly focus on the quality prediction of a single machine, while ignoring dependency relationships among multiple machines in multistage manufacturing process. To tackle the above issues, a novel path enhanced bidirectional graph attention network (PGAT) is proposed in this article. PGAT models the dependencies among machines into directed graphs and introduces graph attention network to encode the dependencies. Nonetheless, it is difficult for graph neural networks to encode long-distance dependencies. Hence, dependency path information is introduced into the features of machines. Moreover, in order to solve the label noise problem that often occurs in actual industrial dataset, a masked loss function is devised. With its help, batch training with noisy labels can be achieved, which improves the training efficiency. Furthermore, experiments are conducted on a public quality prediction dataset collected from an actual production line. PGAT achieves the state-of-the-art results on this dataset, which confirms the effectiveness of PGAT. Additionally, the experimental results demonstrate the critical role of modeling dependency relationships among machines.
As a kind of direct-on-line motor, super premium efficiency (IE4) line-start synchronous reluctance motors (LS-SynRMs) were developed recently and are now used in many applications, including fans, ...pumps, and compressors. This paper presents an optimum design and comparative study of LS-SynRMs with additional losses and impact during the manufacturing process (electrical steel cutting/punching damage as well as squirrel-cage die-casting with bubble effects). The work results indicate that the LS-SynRM design with the "manufacturing process loss" effect should be considered and compensated for the design in order to achieve an IE4 class efficiency and ensure synchronization. Furthermore, the LS-SynRM rotor with multilayer flux barriers and rotor slots is investigated in detail. The influences of optimum design geometrical parameters (flux barriers thickness, segments thickness, length of rotor slots, etc.) on the performances of the basic model and optimum design model are evaluated with finite-element analysis (FEA) results. For more accurate results, the effects of saturation, saliency ratio, inductance difference, and the change in the B-H/B-P curve in damaged motor core edges are considered. Meanwhile, in the squirrel cage, the porosity rate distributions are considered. The copper loss, iron loss, starting torque, power factor, efficiency, and synchronization ability are investigated. The experimental results verify the accuracy of the process presented in this paper.
•The surface modification methods of coatings commonly used in pool boiling are summarized and evaluated.•The influence mechanisms commonly used for pool boiling are summarized and analyzed.•The ...influence mechanisms under different heat fluxes are reviewed, including strengthening and weakening.•The CHF prediction models that can be used for coating structure are summarized and prospected.
With the development of science and technology, the operating power of equipment is getting higher and higher, and the demand for heat dissipation is also increasing. Therefore, thermal management has become a hot topic in recent years. Boiling heat transfer has been considered as a effective solution for heat dissipation. The effect of boiling heat transfer can be enhanced by increasing the surface microstructure and nanocoating. This is the so-called surface modification technology. This paper divides the coating modification methods into two types: physical methods and chemical methods, for sorting and evaluation. For example, common physical methods include spin coating, magnetron sputtering, and chemical methods include chemical vapor deposition, electrochemical cathode and anode methods. In addition, in order to better predict the heat transfer effects of different structures at different stages, this review summarizes the common boiling strengthening mechanisms, evaluates the surface modification methods applied to pool boiling. Finally, critical heat flux (CHF) prediction models that can be used for nanostructured coatings are summarized.