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PDA Journal of Pharmaceutical Science... Jun 2024Challenges in manufacturing of high concentration antibody formulations have seldom been discussed. These are observed mainly form late downstream operations where...
Challenges in manufacturing of high concentration antibody formulations have seldom been discussed. These are observed mainly form late downstream operations where antibody gets concentrated to its final strength, to final fill finish processing and containerization of the product. Present paper summarizes challenges typically observed in manufacturing and processing of high concentration antibody products and provides turnkey solutions to these typical challenges in order to have their consistent and robust manufacturing process. IgG1 has been used as model protein for studying the challenges and providing solutions to them. The late downstream challenges like increased viscosity limiting further concentration can be resolved by used of viscosity modifying agents in the formulation. Replacement of conventionally used 'A' screen membranes with 'D' screen or using single pass TFF can further provide advantage in targeting higher concentrations for same protein with lesser shear and aggregation. Using 0.5μm/0.2μm asymmetric or bilayered membrane instead of conventional 0.2μm membrane resulted in better flux while filtration of high concentration IgG1 formulation. In process holding time during filling operation was optimized to be <60min based on the nozzle drying time for high concentration IgG1 formulation. Appropriate control strategy of replacing filling nozzles and performing periodic fill weight check was proposed for fill finish process of high concentration IgG1 formulation.
PubMed: 38942482
DOI: 10.5731/pdajpst.2023.012873 -
Nature Communications Jun 2024Compounding functional nanoparticles with highly conductive and porous carbon scaffolds is a basic pathway for engineering many important functional devices. However,...
Compounding functional nanoparticles with highly conductive and porous carbon scaffolds is a basic pathway for engineering many important functional devices. However, enabling uniform spatial distribution of functional particles within a massively conjugated, monolithic and mesoporous structure remains challenging, as the high processing temperature for graphitization can arouse nanoparticle ripening, agglomerations and compositional changes. Herein, we report a unique "popcorn-making-mimic" strategy for preparing a highly conjugated and uniformly compounded graphene@NiFeO composite film through a laser-assisted instantaneous compounding method in ambient condition. It can successfully inhibit the unwanted structural disintegration and mass loss during the laser treatment by avoiding oxidation, bursting, and inhomogeneous heat accumulations, thus achieving a highly integrated composite structure with superior electrical conductivity and high saturated magnetization. Such a single-sided film exhibits an absolute shielding effectiveness of up to 20906 dB cm g with 75% absorption rate, superior mechanical flexibility and excellent temperature/humidity aging reliability. These performance indexes signify a substantial advance in EMI absorption capability, fabrication universality, small form-factor and device reliability toward commercial applications. Our method provides a paradigm for fabricating sophisticated composite materials for versatile applications.
PubMed: 38942779
DOI: 10.1038/s41467-024-49498-1 -
ACS Applied Materials & Interfaces Jun 2024In this work, we present a series of nanocomposites for Fused filament fabrication (FFF) based on polycaprolactone (PCL) and chitin nanocrystals (ChNCs). The ChNCs were...
In this work, we present a series of nanocomposites for Fused filament fabrication (FFF) based on polycaprolactone (PCL) and chitin nanocrystals (ChNCs). The ChNCs were synthesized by acid hydrolysis using HCl or lactic acid (LA). The approach using LA, an organic acid, makes the ChNCs synthesis more sustainable and modifies their surface with lactate groups, increasing their compatibility with the PCL matrix. The ChNCs characterization by X-ray diffraction, Fourier transform infrared spectroscopy, scanning electron microscopy, and transmission electron microscopy revealed that both ChNCs presented similar morphologies and crystallinity, while differential scanning calorimetry and thermogravimetric analysis proved that they can bear temperatures up to 210 °C without degrading, which allows their processing in the manufacturing of PCL composites by twin-screw extrusion. Therefore, PCL composites in the form of filaments containing 0.5-1.0 wt % ChNCs were produced and used as feedstock in FFF, and standard tensile and flexural specimens were printed at different temperatures, up to 170 °C, to assess the influence of the ChNCs in the mechanical properties of the material. The tensile testing results showed that the presence of ChNCs enhances the strength and ductility of the PCL matrix, increasing the elongation at break around 20-50%. Moreover, the vertically printed flexural specimens showed a very different bending behavior, such that the pure PCL specimens presented a brittle fracture at 7% strain, while the ChNCs composites were able to bend over themselves. Hence, this work proves that the presence of ChNCs aims to improve the interlayer adhesion of the objects manufactured by FFF due to their good adhesive properties, which is currently a concern for the scientific community and the industrial sector.
PubMed: 38941240
DOI: 10.1021/acsami.4c06358 -
Cureus May 2024Background and objective Exposure to sunlight's ultraviolet (UV) radiation poses various health risks, including sunburn, skin damage, and heightened skin cancer risk....
Background and objective Exposure to sunlight's ultraviolet (UV) radiation poses various health risks, including sunburn, skin damage, and heightened skin cancer risk. Sunblock usage has surged due to widespread advertising campaigns. Individuals spending time outdoors should employ protective measures like wearing hats, applying sunblock with a high sun protection factor (SPF), covering exposed skin, and seeking shade to mitigate UV exposure's harmful effects. This study's objective is to assess participants' experiences and satisfaction with SPF 100 sunscreen in actual use conditions. Methodology This study employed a prospective, single-center design involving 100 participants aged 18 to 70 years. Eligible individuals had Fitzpatrick skin types I-III and were engaged in outdoor activities, excluding those with certain medical conditions or medication use. Each participant received sunscreen tubes (Solero SPF 100, Helix Pharma Pvt. Ltd., Karachi, Pakistan), and clinical evaluations were conducted on the day before and after and day 22 visits, with sunblock application and UV-induced erythema assessments performed. Results Our study enrolled participants with a mean age of 25.6 ± 7.1 years, ranging from 15 to 55 years, with females comprising 84% (84) of the sample. Results revealed widespread satisfaction and acceptance of SPF 100 sunscreen, without any reported adverse reactions. A significant majority expressed their willingness to purchase and recommend the sunscreen to others. Furthermore, the majority of healthcare providers expressed satisfaction with prescribing this sunscreen. Conclusions In conclusion, SPF 100 sunscreen demonstrated excellent tolerability and acceptability among participants, suggesting its potential utility in both personal sun protection routines and clinical settings.
PubMed: 38939303
DOI: 10.7759/cureus.61212 -
Cureus May 2024Heated tobacco products represent a novel category of tobacco products in which a tobacco consumable is heated to a temperature that releases nicotine from the tobacco... (Review)
Review
Heated tobacco products represent a novel category of tobacco products in which a tobacco consumable is heated to a temperature that releases nicotine from the tobacco leaf but not to a temperature sufficient to cause combustion. Heated tobacco products may therefore have the potential to be a less harmful alternative for adult smokers who would otherwise continue to smoke cigarettes, as their use should result in exposure to substantially fewer and lower levels of toxicants. This update represents a two-year extension to our previous narrative review, which covered peer-reviewed journal articles published up to August 31, 2021. The scientific evidence published between 2021 and 2023 continues to indicate that aerosols produced from heated tobacco products contain fewer and substantially lower levels of harmful and potentially harmful constituents and that these observed reductions consistently translate to reduced biological effects in both and toxicological studies. Biomarker and clinical data from studies in which product use is controlled within a clinical setting continue to suggest changes in levels of biomarkers of exposure, biomarkers of potential harm, and clinical endpoints indicating the potential for reduced harm with switching to exclusive use of heated tobacco products in adult smokers. Overall, the available peer-reviewed scientific evidence continues to indicate that heated tobacco products offer promise as a potentially less harmful alternative to cigarettes, and as such, the conclusions of our original narrative review remain valid.
PubMed: 38939262
DOI: 10.7759/cureus.61223 -
Materials Horizons Jun 2024Reversible adhesion with on-demand attachment and detachment is used by many animals for their locomotion. However, achieving robust and switchable adhesion on rough...
Reversible adhesion with on-demand attachment and detachment is used by many animals for their locomotion. However, achieving robust and switchable adhesion on rough surfaces in artificial adhesives remains a significant challenge. Here, we present a snail mucus-inspired touch-initiate adhesive (TIA), showing robust adhesions on various surfaces. TIA is a polymeric hydrogel photo-cured with the presence of supersaturated sodium acetate (NaAc) in the precursor solution. TIA is soft and flexible at room temperature, allowing it to form conformal contact with objects with various surfaces. The contact with the target surface immediately initiates the crystallization of TIA, increasing the elastic modulus of TIA by an order of magnitude. The increased modulus and the interlocking with the target surfaces thus results in an adhesion strength up to 465.56 ± 84.05 kPa. TIA can be easily detached from the surface by heating to a temperature above 58 °C, showing an adhesion strength of 12.71 ± 2.73 kPa. The detached TIA, even cooled down to and kept at room temperature, is readily used for the subsequent adhesion. The study here not only provides a highly adhesive material for on-demand attachment to various surfaces, but also proposes a new design strategy to compose smart materials.
PubMed: 38932648
DOI: 10.1039/d4mh00331d -
Polymers Jun 2024Head impacts are a major concern in contact sports and sports with high-speed mobility due to the prevalence of head trauma events and their dire consequences....
Head impacts are a major concern in contact sports and sports with high-speed mobility due to the prevalence of head trauma events and their dire consequences. Surrogates of human heads are required in laboratory testing to safely explore the efficacy of impact-mitigating mechanisms. This work proposes using polymer additive manufacturing technologies to obtain a substitute for the human skull to be filled with a silicone-based brain surrogate. This assembly was instrumentalized with an Inertial Measurement Unit. Its performance was compared to a standard Hybrid III head form in validation tests using commercial headgear. The tests involved impact velocities in a range centered around 5 m/s. The results show a reasonable homology between the head substitutes, with a disparity in the impact response within 20% between the proposed surrogate and the standard head form. The head surrogate herein developed can be easily adapted to other morphologies and will significantly decrease the cost of the laboratory testing of head protection equipment, all while ensuring the safety of the testing process.
PubMed: 38932102
DOI: 10.3390/polym16121753 -
Polymers Jun 2024Traditional metal-plastic dissimilar welding methods directly heat the metal workpiece, which may cause potential thermal damage to the metal workpiece. Ultrasonic...
Traditional metal-plastic dissimilar welding methods directly heat the metal workpiece, which may cause potential thermal damage to the metal workpiece. Ultrasonic extruded weld-riveting (UEWR) is a relatively new method for dissimilar joining of carbon fiber-reinforced thermoplastic (CFRTP) and metal. In this method, the CFRTP workpiece is melted using the ultrasonic effect and is squeezed into prefabricated holes in the metal workpiece to form a rivet structure. In this method, the metal workpiece is not directly heated, and potential high-temperature losses can be avoided. This paper investigates the process characterizations of UERW of AZ31B magnesium alloy to carbon fiber-reinforced PA66. The process parameters are optimized by the Taguchi method. The joint formation process is analyzed based on the fiber distribution in the cross-sections of joints. The effects of welding parameters on the joint microstructure and fracture surface morphology are discussed. The results show that a stepped amplitude strategy (40 μm amplitude in the first stage and 56 μm amplitude in the second stage) could balance the joint strength and joint appearance. Insufficient (welding energy < 2600 J or amplitude-A < 50%) or excessive (welding energy > 2800 J or amplitude-A > 50%) welding parameters lead to the formation of porous defects. Three fracture modes are identified according to the fracture surface analysis. The maximum tensile shear strength of joints at the optimal parameters is about 56.5 ± 6.2 MPa.
PubMed: 38932099
DOI: 10.3390/polym16121749 -
Pharmaceutics May 2024Archaeosomes were manufactured from natural archaeal lipids by a microfluidics-assisted single-step production method utilizing a mixture of di- and tetraether lipids...
Archaeosomes were manufactured from natural archaeal lipids by a microfluidics-assisted single-step production method utilizing a mixture of di- and tetraether lipids extracted from The primary aim of this study was to investigate the exceptional stability of archaeosomes as potential carriers for oral drug delivery, with a focus on powdered formulations. The archaeosomes were negatively charged with a size of approximately 100 nm and a low polydispersity index. To assess their suitability for oral delivery, the archaeosomes were loaded with two model drugs: calcein, a fluorescent compound, and insulin, a peptide hormone. The archaeosomes demonstrated high stability in simulated intestinal fluids, with only 5% of the encapsulated compounds being released after 24 h, regardless of the presence of degrading enzymes or extremely acidic pH values such as those found in the stomach. In a co-culture cell model system mimicking the intestinal barrier, the archaeosomes showed strong adhesion to the cell membranes, facilitating a slow release of contents. The archaeosomes were loaded with insulin in a single-step procedure achieving an encapsulation efficiency of approximately 35%. These particles have been exposed to extreme manufacturing temperatures during freeze-drying and spray-drying processes, demonstrating remarkable resilience under these harsh conditions. The fabrication of stable dry powder formulations of archaeosomes represents a promising advancement toward the development of solid dosage forms for oral delivery of biological drugs.
PubMed: 38931818
DOI: 10.3390/pharmaceutics16060694 -
Sensors (Basel, Switzerland) Jun 2024A prerequisite for continuous transport systems' operation is their digital transformation, which interprets operating conditions based on the availability of a wide...
A prerequisite for continuous transport systems' operation is their digital transformation, which interprets operating conditions based on the availability of a wide range of data and information in the form of measured quantities that can be obtained, for example, by experimental measurement. To implement digital transformation in continuous transport systems, it is necessary to examine and analyze the informative value of individual measured quantities in detail. Research in this area must focus on identifying addressable quantities with a clear, informative value. Such an approach enables the monitoring of continuous transport systems operation and performance of operational diagnostics, the objective of which should be identifying undesirable operating conditions. Within this paper, research will be presented aiming to verify the hypothesis that, based on a measurement of selected parameters, it is possible to identify belt mistracking in a continuous transport system. Belt mistracking is an undesirable condition that can cause a conveyor belt to converge and thus seriously turn off an entire transport system. The research results confirmed the established hypothesis. Based on this, an evaluation algorithm was created for on-time evaluation. The proposed algorithm is also suitable for the needs of a digital twin of a continuous transport system.
PubMed: 38931594
DOI: 10.3390/s24123810