This study aimed to develop a value-added bio-based polymer product for food packaging. Poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV) is a promising bioplastic with limitations in processability and brittleness, which our group previously addressed by incorporating high-molecular-weight natural rubber (NR) compatibilized with peroxide and coagent. Yet, processability in an industrial setting proved difficult. Coffee oil epoxide (COE), a waste-derived plasticizer, was incorporated into the PHBV/NR/peroxide/coagent matrix via extrusion, and properties of resulting sheets were evaluated. COE incorporation significantly decreased the oxygen and water permeability of the PHBV/NR sheets. Maximum degradation temperature Tpeak (°C) increased by ~4.6 °C, and degree of crystallinity decreased by ~15.5% relative to pristine PHBV, indicating good thermal stability. Melting (Tm) and glass transition temperatures (Tg) of the PHBV/NR blend remained unchanged with COE incorporation. X-ray diffraction (XRD) revealed ~10.36% decrease in crystal size for the plasticized blend. Energy-dispersive X-ray analysis (EDAX) and scanning electron microscopy (SEM) confirmed good dispersion with no phase separation. The water uptake capacity of the plasticized blend was reduced by 61.02%, while surface contact angle measurements showed improved water resistance. The plasticized PHBV sheet shows promise for environmentally friendly packaging films due to its high thermal stability, effective barrier properties, and industrial scalability.

The aim of this study was to rapidly develop a sufficiently robust andrographolide nanosuspension (AG-NS) system using hummer acoustic resonance (HAR) technology. The system can effectively improve the dissolution properties of AG, while having high stability and scale-up adaptability. The formulation of AG-NS was optimized in a high-throughput manner using HAR technology and the preparation process was optimized stepwise. Optimal AG-NS with Z-Ave = 223.99 ± 3.16 nm, PDI=0.095 ± 0.007 and zeta potential = -33.20 ± 0.58 mV was successfully prepared with Polyvinylpyrrolidone K30 and Sodium dodecyl sulfate. The optimal prescription was successfully scaled up 100 and 150 times using HAR technology, which was the initial exploration of its commercial scale production. AG-NS was solidified using freeze drying and fluid bed technology, respectively. The optimal AG-NS and its solidified products were exhaustively characterized using various analytical techniques. The high energy input of HAR technology and drying process converted part of the drug into the amorphous state. The in-vitro drug dissolution studies demonstrated relatively higher drug dissolution for AG-NS and its solidified products compared to controls at both the dissolution media (pH 1.2 buffer and pH 6.8 buffer). AG-NS and its solidified products successfully maintained their physical stability in short-term stability and accelerated stability experiments, respectively.

Methane, either as natural gas or as a resource obtained from various bioprocesses (e.g., digestion, landfill) can be converted to carbon and hydrogen according to. CH4(g)→C(s)+2H2(g)ΔH298K=74.8kJ/mol. Previous research has stressed the growing importance of substituting the high-temperature Steam Methane Reforming (SMR) by a moderate temperature Catalytic Methane Decomposition (CMD). The carbon formed is moreover of nanotube nature, in high industrial demand. To avoid the use of an inert support for the active catalyst species, e.g., Al2O3 for Fe, leading to a progressive contamination of the catalyst by support debris and coking of the catalyst, the present research investigates the use of carbon nanotubes (CNTs) as Fe-support. Average CH4 conversions of 75-85% are obtained at 700 °C for a continuous operation of 40 h. The produced CNT from the methane conversion can be continuously removed from the catalyst bed by carry-over due to its bulk density difference (∼120 kg/m3) with the catalyst itself (∼1500 kg/m3). CNT properties are fully specified. No thermal regeneration of the catalyst is required. A tentative process layout and economic analysis demonstrate the scalability of the process and the very competitive production costs of H2 and CNT.

In counter-current chromatography (CCC), linear scale-up is an ideal amplification strategy. However, when transferring from analytical to predictable preparative processes with high throughput, linear scale-up would be challenging due to limitations imposed by differences in instrument parameters, such as gravitational forces, tubing cross-section area, tubing length, column volume and flow rate. Some effective scale-up strategies have been studied for different instrument parameters, but so far, these scale-up works have only been tested on standard circular (SC) tubing. The previous research of our group found that rectangular horizontal (RH) tubing can double the separation efficiency compared with conventional SC tubing, and has industrial production potential. This paper used the separation of tilianin from Dracocephalum moldavica L. as an example to demonstrate how to scale up the optimized process from analytical SC tubing to preparative RH tubing. After systematic optimization of solvent systems, sample concentration and flow rate on the analytical CCC, the optimized parameters obtained were successfully transferred to the preparative CCC. The results showed that a crude sample of 2.07 g was successfully separated using a solvent system of n-hexane - ethyl acetate - ethanol - water (1:4:1:5, v/v/v/v) in reversed phase mode, and the three consecutive separations produced a total of 380 mg tilianin in 75 min with high purities of 98.3%, as analyzed by HPLC. The total throughput achieved from the analytical to semi-preparative scale was improved by 138 times (from 12 mg/h to 1.66 g/h), while the column volume was increased by only 46.5 times (from 15.5 mL to 720 mL). This is the successful application of CCC for the separation and purification of tilianin. Given that SC tubing is the traditional configuration for CCC columns, this study is a necessary step to prove the applicability of RH tubing columns for routine use and potential large-scale industrial applications.

BACKGROUND: Wharton\'s jelly-derived mesenchymal stem cells (WJ-MSCs) hold great therapeutic potential in regenerative medicine. Therefore, it is crucial to establish a Good Manufacturing Practice (GMP)-compliant methodology for the isolation and culture of WJ-MSCs. Through comprehensive research, encompassing laboratory-scale experiments to pilot-scale studies, we aimed to develop standardized protocols ensuring the high yield and quality of WJ-MSCs manufacturing.
METHODS: Firstly, optimization of parameters for the enzymatic digestion method used to isolate WJ-MSCs was conducted. These parameters included enzyme concentrations, digestion times, seeding densities, and culture media. Additionally, a comparative analysis between the explant method and the enzymatic digestion method was performed. Subsequently, the consecutive passaging of WJ-MSCs, specifically up to passage 9, was evaluated using the optimized method. Finally, manufacturing processes were developed and scaled up, starting from laboratory-scale flask-based production and progressing to pilot-scale cell factory-based production. Furthermore, a stability study was carried out to assess the storage and use of drug products (DPs).
RESULTS: The optimal parameters for the enzymatic digestion method were a concentration of 0.4 PZ U/mL Collagenase NB6 and a digestion time of 3 h, resulting in a higher yield of P0 WJ-MSCs. In addition, a positive correlation between the weight of umbilical cord tissue and the quantities of P0 WJ-MSCs has been observed. Evaluation of different concentrations of human platelet lysate revealed that 2% and 5% concentrations resulted in similar levels of cell expansion. Comparative analysis revealed that the enzymatic digestion method exhibited faster outgrowth of WJ-MSCs compared to the explant method during the initial passage. Passages 2 to 5 exhibited higher viability and proliferation ability throughout consecutive passaging. Moreover, scalable manufacturing processes from the laboratory scale to the pilot scale were successfully developed, ensuring the production of high-quality WJ-MSCs. Multiple freeze-thaw cycles of the DPs led to reduced cell viability and viable cell concentration. Subsequent thawing and dilution of the DPs resulted in a significant decrease in both metrics, especially when stored at 20-27 °C.
CONCLUSIONS: This study offers valuable insights into optimizing the isolation and culture of WJ-MSCs. Our scalable manufacturing processes facilitate the large-scale production of high-quality WJ-MSCs. These findings contribute to the advancement of WJ-MSCs-based therapies in regenerative medicine.

The scale-up of animal cell cultivation is important but remains complex and challenging. In the present study, we propose a novel scale-up strategy for baby hamster Syrian kidney-21 (BHK-21) cell cultivation based on similar hydrodynamic environments. The hydrodynamic characteristics of the different scale bioreactors were determined by computational fluid dynamics (CFD) and further correlated with the agitation speed. The optimal hydrodynamic environment for cell cultivation and vaccine production was determined from the cultivation experiments of BHK-21 cells in 5-L laboratory-scale bioreactors equipped with different impellers at various agitation speeds. BHK-21 cell cultivation was scaled up from 5-L to 42-, 350-, and 1000-L bioreactors by adjusting the agitation speed to make the hydrodynamic features similar to those in the 5-L bioreactor, especially for the shear rate in the impeller zone (γimp) and energy dissipation rate in the tank bulk zone (εtan). The maximum cell density and cell aggregation rate in these scaled-up bioreactors were in the range of 4.6 × 106 ~ 4.8 × 106 cells/mL and 16 ~ 20%, which are comparable to or even better than those observed in the 5-L bioreactor (maximum cell density 4.8 × 106 cells/mL, cell aggregation rate 21%). The maximum virus titer of 108.0 LD50/mL achieved in the 1000-L bioreactor was close to 108.3 LD50/mL that obtained in the 5-L bioreactor. Hence, the scale-up strategy proposed in this study is feasible and can efficiently facilitate the scale-up processes of animal cell cultivation.

Exosomes are small extracellular vesicles (sEVs) secreted by cells. With advances in the study of sEVs, they have shown great potential in the diagnosis and treatment of disease. However, sEV therapy usually requires a certain dose and purity of sEVs to achieve the therapeutic effect, but the existing sEV purification technology exists in the form of low yield, low purity, time-consuming, complex operation and many other problems, which greatly limits the application of sEVs. Therefore, how to obtain high-purity and high-quality sEVs quickly and efficiently, and make them realize large-scale production is a major problem in current sEV research. This paper discusses how to improve the purity and yield of sEVs from the whole production process of sEVs, including the upstream cell line selection and cell culture process, to the downstream isolation and purification, quality testing and the final storage technology.

Microbial fuel cells (MFCs) are an emerging technology in renewable energy and waste treatment and the scale-up is crucial for practical applications. Undoubtedly, the analysis and comprehension of MFC operation necessitate essential information regarding the response of the current distribution to variable operating conditions, which stands as one of its significant dynamic characteristics. In this study, the dynamic responses of current distribution to external stimuli (external load, temperature, pH, and electrolyte concentration) were investigated by employing a segmented anode current collector in a liter-scale MFC. The results demonstrated that, with respect to the anodic segment close to the cathode, a major response of the segment current to changes in load, temperature and pH was observed while minor response to changes in ion concentration. It was also found that external stimuli-induced high current usually led to a worse current distribution while increasing electrolyte ion concentration could simultaneously improve the maximal power generation and current distribution. In addition, the response time of segment current to input stimulus followed the pattern of temperature ˃ pH ˃ ion concentration ˃ external load. The results and implication of this study would be helpful in enhancing the operational stability of scale-up MFCs in future practical application.

Transparent wood composites (TWs) offer the possibility of unique coloration effects. A colored transparent wood composite (C-TW) with enhanced fire retardancy was impregnated by metal ion solutions, followed by methyl methacrylate (MMA) impregnation and polymerization. Bleached birch wood with a preserved hierarchical structure acted as a host for metal ions. Cobalt, nickel, copper, and iron metal salts were used. The location and distribution of metal ions in C-TW as well as the mechanical performance, optical properties, and fire retardancy were investigated. The C-TW coloration is tunable by controlling the metal ion species and concentration. The metal ions reduced heat release rates and limited the production of smoke during forced combustion tests. The potential for scaled-up production was verified by fabricating samples with a dimension of 180 × 100 × 1 (l × b × h) mm3.

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