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1.
J Mech Behav Biomed Mater ; 158: 106644, 2024 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-39088941

RESUMO

Ceramic lattices hold great potential for bone scaffolds to facilitate bone regeneration and integration of native tissue with medical implants. While there have been several studies on additive manufacturing of ceramics and their osseointegrative and osteoconductive properties, there is a lack of a comprehensive examination of their mechanical behavior. Therefore, the aim of this study was to assess the mechanical properties of different additively manufactured ceramic lattice structures under different loading conditions and their overall ability to mimic bone tissue properties. Eleven different lattice structures were designed and manufactured with a porosity of 80% using two materials, hydroxyapatite (HAp) and zirconium dioxide (ZrO2). Six cell-based lattices with cubic and hexagonal base, as well as five Voronoi-based lattices were considered in this study. The samples were manufactured using lithography-based ceramic additive manufacturing and post-processed thermally prior to mechanical testing. Cell-based lattices with cubic and hexagonal base, as well as Voronoi-based lattices were considered in this study. The lattices were tested under four loading conditions: compression, four-point bending, shear and tension. The manufacturing process of the different ceramics leads to different deviations of the lattice geometry, hence, the elastic properties of one structure cannot be directly inferred from one material to another. ZrO2 lattices prove to be stiffer than HAp lattices of the same designed structure. The Young's modulus for compression of ZrO2 lattices ranges from 2 to 30GPa depending on the used lattice design and for HAp 200MPa to 3.8GPa. The expected stability, the load where 63.2% of the samples are expected to be destroyed, of the lattices ranges from 81 to 553MPa and for HAp 6 to 42MPa. For the first time, a comprehensive overview of the mechanical properties of various additively manufactured ceramic lattice structures is provided. This is intended to serve as a reference for designers who would like to expand the design capabilities of ceramic implants that will lead to an advancement in their performance and ability to mimic human bone tissue.

2.
Water Res ; 262: 122111, 2024 Jul 17.
Artigo em Inglês | MEDLINE | ID: mdl-39089122

RESUMO

Use of high-pressure membranes is an effective means for removal of per-and polyfluoroalkyl substances (PFAS) that is less sensitive than adsorption processes to variable water quality and specific PFAS structure. This study evaluated the use of nanofiltration (NF) membranes for the removal of PFAS and industry relevant co-contaminants in semiconductor fabrication (fab) wastewater. Initial experiments using a flat sheet filtration cell determined that the NF90 (tight NF) membrane provided superior performance compared to the NF270 (loose NF) membrane, with NF90 rejection values exceeding 97 % for all PFAS evaluated, including the ultrashort trifluoromethane sulfonic acid (TFMS). Cationic fab co-contaminants diaryliodonium (DIA), triphenylsulfonium (TPS), and tetramethylammonium hydroxide (TMAH) were not as highly rejected as anionic PFAS likely due to electrostatic effects. A spiral wound NF90 module was then used in a pilot system to treat a lab solution containing PFAS and co-contaminants and fab wastewater effluent. Treatment of the fab wastewater, containing high concentrations of perfluorocarboxylic acids (PFCAs), including trifluoroacetic acid (TFA: 96,413 ng/L), perfluoropropanoic acid (PFPrA: 11,796 ng/L), and perfluorobutanoic acid (PFBA: 504 ng/L), resulted in ≥92 % rejection of all PFAS while achieving 90 % water recovery in a semi-batch configuration. These findings demonstrate nanofiltration as a promising technology option for incorporation in treatment trains targeting PFAS removal from wastewater matrices.

3.
Front Mol Med ; 4: 1310002, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39086435

RESUMO

Since the FDA's approval of chimeric antigen receptor (CAR) T cells in 2017, significant improvements have been made in the design of chimeric antigen receptor constructs and in the manufacturing of CAR T cell therapies resulting in increased in vivo CAR T cell persistence and improved clinical outcome in certain hematological malignancies. Despite the remarkable clinical response seen in some patients, challenges remain in achieving durable long-term tumor-free survival, reducing therapy associated malignancies and toxicities, and expanding on the types of cancers that can be treated with this therapeutic modality. Careful analysis of the biological factors demarcating efficacious from suboptimal CAR T cell responses will be of paramount importance to address these shortcomings. With the ever-expanding toolbox of experimental approaches, single-cell technologies, and computational resources, there is renowned interest in discovering new ways to streamline the development and validation of new CAR T cell products. Better and more accurate prognostic and predictive models can be developed to help guide and inform clinical decision making by incorporating these approaches into translational and clinical workflows. In this review, we provide a brief overview of recent advancements in CAR T cell manufacturing and describe the strategies used to selectively expand specific phenotypic subsets. Additionally, we review experimental approaches to assess CAR T cell functionality and summarize current in silico methods which have the potential to improve CAR T cell manufacturing and predict clinical outcomes.

4.
Cureus ; 16(7): e63559, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-39087194

RESUMO

The diagnosis and treatment of pelvic bone hydatidosis (BH) present substantial challenges for orthopedic surgeons, requiring collaboration with parasitologists, radiologists, pathologists, and engineers. Surgical treatment selection depends on factors such as the extent of bone loss, soft tissue management, previously applied therapies, and local colonization status. This report details the advanced management of two young patients diagnosed late with severe cystic pelvic BH, an atypical presentation due to their geographic origin and age. Following extensive diagnostic assessments, including serology and 3D imaging, the patients underwent a two-step surgical intervention. The initial surgery involved extensive debridement and the placement of a poly-methyl-methacrylate spacer, followed by a second procedure utilizing a custom-made, tri-flanged implant for definitive pelvic reconstruction. The custom implant, designed via an electron beam melting process, successfully restored hip functionality and anatomy, as evidenced by improvements in functional scores and post-operative imaging. Short-term monitoring confirmed the integration of the implant and the absence of infection recurrence, demonstrating the approach's effectiveness. These cases highlight the potential of using additive manufacturing (AM) to create patient-specific implants for managing complex hip cases and emphasize the necessity for early detection and a multidisciplinary approach in treatment planning.

5.
Heliyon ; 10(14): e34294, 2024 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-39092246

RESUMO

This investigation presents a critical analysis of mouthguard production, focusing on the evaluation of conventional vs additive manufacturing methods, the materials involved, and aspects such as their failure and prevention. It also summarizes the current trends, perspectives, and the main limitations. It is shown that some of the shortcomings can be solved by implementing additive manufacturing technologies, which are systematically reviewed in this research. Due to the specific materials used to produce mouthguards, there are certain additive manufacturing technologies that dominate and a wide variety of raw materials. The costs vary depending on the technology.

6.
Dent Mater ; 2024 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-39095245

RESUMO

OBJECTIVE: To formulate an experimental methacrylate-based photo-polymerizable resin for 3D printing with ytterbium trifluoride as filler and to evaluate the mechanical, physicochemical, and biological properties. METHODS: Resin matrix was formulated with 60 wt% UDMA, 40 wt% TEGDMA, 1 wt% TPO, and 0.01 wt% BHT. Ytterbium Trifluoride was added in concentrations of 1 (G1 %), 2 (G2 %), 3 (G3 %), 4 (G4 %), and 5 (G5 %) wt%. One group remained without filler addition as control (GC). The samples were designed in 3D builder software and printed using a UV-DLP 3D printer. The samples were ultrasonicated with isopropanol and UV cured for 60 min. The resins were tested for degree of conversion (DC), flexural strength, Knoop microhardness, softening in solvent, radiopacity, colorimetric analysis, and cytotoxicity (MTT and SRB). RESULTS: Post-polymerization increased the degree of conversion of all groups (p < 0.05). G2 % showed the highest DC after post-polymerization. G2 % showed no differences in flexural strength from the G1 % and GC (p > 0.05). All groups showed a hardness reduction after solvent immersion. No statistical difference was found in radiopacity, softening in solvent (ΔKHN%), colorimetric spectrophotometry, and cytotoxicity (MTT) (p > 0.05). G1 % showed reduced cell viability for SRB assay (p < 0.05). SIGNIFICANCE: It was possible to produce an experimental photo-polymerizable 3D printable resin with the addition of 2 % ytterbium trifluoride as filler without compromising the mechanical, physicochemical, and biological properties, comparable to the current provisional materials.

7.
Farm Hosp ; 48 Suppl 1: S21-S27, 2024 Jul.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-39097363

RESUMO

The huge development that Advanced Therapy Medicinal Products (AMTPs) have experienced in recent years, both commercial and research, represent a challenge for Hospital Pharmacy at all levels. The aim of this article is to describe the implementation of an Advanced Therapies Unit (AUT) and the process of preparation of the AMTPs according to the "good manufacturing practices" (GMP), as well as the results obtained in a tertiary hospital, as an example of the challenges posed by MTA's academic production. The AUT meets the requirements established in the GMP by guaranteeing that the medicines produced therein are of the quality required for the use for which they are intended, and also provides support to various research groups involved in the development of AMTPs. The AUT is composed of a highly qualified multidisciplinary team, qualified and trained in GMP, and is authorized for the preparation of five types of AMTPs consisting of allogeneic virus-specific T cells (VST) with various viral specificities. A circuit has been established in collaboration between the UTA and the Pharmacy Service with the Hematology Service for the assessment of the clinical indication, the request and preparation of VST, which allows the treatment of patients receiving hematopoietic stem cell transplants who present viral reactivations resistant or refractory to standard treatment, or who cannot tolerate it due to toxicity. Preliminary results from these AMTPs suggest that VSTs are an effective and safe alternative. Academic AMTPs have special interest in orphan indications or in the absence of alternative treatments, and their production through the "hospital exemption" can favor early access in the initial phases of development and at a lower cost. It is essential to promote the training of hospital pharmacists in GMP and their participation in collaboration with other clinicians and researchers to develop AMTPs that meet all logistical and regulatory requirements.


Assuntos
Serviço de Farmácia Hospitalar , Humanos , Serviço de Farmácia Hospitalar/organização & administração , Terapias em Estudo
8.
Farm Hosp ; 48 Suppl 1: TS21-TS27, 2024 Jul.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-39097372

RESUMO

The huge development that advanced therapy medicinal products (AMTPs) have experienced in recent years, both commercial and research, represent a challenge for hospital pharmacy at all levels. The aim of this article is to describe the implementation of an advanced therapies unit (AUT) and the process of preparation of the AMTPs according to the "good manufacturing practices" (GMP), as well as the results obtained in a tertiary hospital, as an example of the challenges posed by MTA's academic production. The AUT meets the requirements established in the GMP by guaranteeing that the medicines produced therein are of the quality required for the use for which they are intended, and also provides support to various research groups involved in the development of AMTPs. The AUT is composed of a highly qualified multidisciplinary team, qualified and trained in GMP, and is authorized for the preparation of 5 types of AMTPs consisting of allogeneic virus-specific T cells (VST) with various viral specificities. A circuit has been established in collaboration between the UTA and the pharmacy service with the hematology service for the assessment of the clinical indication, the request, and preparation of VST, which allows the treatment of patients receiving hematopoietic stem cell transplants who present viral reactivations resistant or refractory to standard treatment, or who cannot tolerate it due to toxicity. Preliminary results from these AMTPs suggest that VSTs are an effective and safe alternative. Academic AMTPs have special interest in orphan indications or in the absence of alternative treatments, and their production through the "hospital exemption" can favor early access in the initial phases of development and at a lower cost. It is essential to promote the training of hospital pharmacists in GMP and their participation in collaboration with other clinicians and researchers to develop AMTPs that meet all logistical and regulatory requirements.


Assuntos
Serviço de Farmácia Hospitalar , Humanos , Serviço de Farmácia Hospitalar/organização & administração , Terapias em Estudo
9.
Foot Ankle Surg ; 2024 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-39097425

RESUMO

BACKGROUND: Collapse of the talus and peri-talar arthritis pose treatment challenges due to the anatomy and location of the talus as a keystone of the foot and ankle. Custom 3D-printed total talus replacement (TTR) and combined total ankle total talus replacement (TATTR) have emerged as treatment options for these pathologies. However, the safety and efficacy of these implants is unknown due to the limited number of cases and short follow-up durations. METHODS: This was a retrospective study to assess surgical outcomes of patients who underwent a TTR and TATTR with or without subtalar fusion. Patient demographics, intraoperative parameters, device related surgical and non-surgical events, imaging and clinical evaluations, and patient reported outcome (PRO) measures were compiled. RESULTS: A total of 38 patients received a custom 3D-printed implant with mean follow-up time of 22.1 (range: 12-45) months. In this cohort, 7 (18.4 %) required secondary surgery and 3 (7.9 %) required implant removal. Multivariate logistic regression revealed that patient diagnosis of depression was a significant predictor of secondary surgery with an OR 17.50 (p = 0.037). Significant postoperative improvements were observed in the talocalcaneal height (p = 0.005) and talar declination angle (p = 0.013) for the TATTR group. VAS and PROMIS pain interference (PI) scores demonstrated an initial significant improvement in pain, but this improvement did not maintain significance at most recent follow-up. However, there was a significant increase in the PROMIS physical function (PF) scores (p = 0.037) at most recent follow-up. CONCLUSION: These results demonstrate that TTR and TATTR provide significant improvement in post-operative radiographic foot and ankle alignment and physical function at the two-year timepoint. PRO findings suggest that patients are more active after surgery. Surgeons considering proceeding with either of these procedures should counsel patients about pain and functional outcomes as well as realistic expectations in patients with depression. LEVEL OF EVIDENCE: Level 3.

10.
Adv Mater ; : e2408374, 2024 Jul 25.
Artigo em Inglês | MEDLINE | ID: mdl-39049689

RESUMO

Advances in additive manufacturing in composites have transformed aerospace, medical devices, tissue engineering, and electronics. A key aspect of enhancing properties of 3D-printed objects involves fine-tuning the material by embedding and orienting reinforcement within the structure. Existing methods for orienting these reinforcements are limited by pattern types, alignment, and particle characteristics. Acoustics offers a versatile method to control the particles independent of their size, geometry, and charge, enabling intricate pattern formations. However, integrating acoustics into 3D printing has been challenging due to the scattering of the acoustic field between polymerized layers and unpolymerized resin, resulting in unwanted patterns. To address this challenge, SonoPrint, an innovative acoustically assisted volumetric 3D printer is developed that enables simultaneous reinforcement patterning and printing of the entire structure. SonoPrint generates mechanically tunable composite geometries by embedding reinforcement particles, such as microscopic glass, metal, and polystyrene, within the fabricated structure. This printer employs a standing wave field to create targeted particle motifs-including parallel lines, radial lines, circles, rhombuses, hexagons, and polygons-directly in the photosensitive resin, completing the print in just a few minutes. SonoPrint enhances structural properties and promises to advance volumetric printing, unlocking applications in tissue engineering, biohybrid robots, and composite fabrication.

11.
Artigo em Inglês | MEDLINE | ID: mdl-39049741

RESUMO

INTRODUCTION: Microneedles (MNs) are miniaturized, painless, and minimally invasive platforms that have attracted significant attention over recent decades across multiple fields, such as drug delivery, disease monitoring, disease diagnosis, and cosmetics. Several manufacturing methods have been employed to create MNs; however, these approaches come with drawbacks related to complicated, costly, and time-consuming fabrication processes. In this context, employing additive manufacturing (AM) technology for MN fabrication allows for the quick production of intricate MN prototypes with exceptional precision, providing the flexibility to customize MNs according to the desired shape and dimensions. Furthermore, AM demonstrates significant promise in the fabrication of sophisticated transdermal drug delivery systems and medical devices through the integration of MNs with various technologies. AREAS COVERED: This review offers an extensive overview of various AM technologies with great potential for the fabrication of MNs. Different types of MNs and the materials utilized in their fabrication are also discussed. Recent applications of 3D-printed MNs in the fields of transdermal drug delivery and biosensing are highlighted. EXPERT OPINION: This review also mentions the critical obstacles, including drug loading, biocompatibility, and regulatory requirements, which must be resolved to enable the mass-scale adoption of AM methods for MN production, and future trends.

12.
Heliyon ; 10(13): e33520, 2024 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-39050412

RESUMO

To identify the effect and mechanism of servitization level and digital transformation on the performance of listed sporting goods manufacturing enterprises in China, we construct an index to measure the degree of digital transformation using data from 31 sporting goods manufacturing firms listed on Shanghai and Shenzhen A-shares and the New Over-the-Counter Market in China. The study uses the proportion of service business income in enterprise operating income to quantify servitization level, by analyzing the semantic expression of national digital economy policy and collecting digital category keywords from enterprise annual reports using crawler technology. Thereafter, we analyze the impact of servitization extent and digital transformation on company outcomes as well as if digital evolution acts as a moderating factor between servitization and company outcomes. The findings indicate that the extent of servitization reduces the outcomes of publicly traded sporting commodities production companies, showing a servitization paradox occurrence. Digital transformation degree has a positive U-shaped impact on enterprise performance and a weak positive moderating effect on servitization level and enterprise performance.

13.
Heliyon ; 10(13): e33551, 2024 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-39050440

RESUMO

Industry 5.0 has the capacity to surpass the technology -oriented efficiency of Industry 4.0 and advance sustainable development objectives such as prioritizing human needs, ensuring socio-environmental sustainability, and enhancing resilience. Digital twins and simulation technologies improve manufacturing, evaluate products and operations, and predict any potential adverse consequences. With digital twin technology, everything that exists in the physical world will eventually be duplicated in the digital realm. Within the context of Industry 5.0, this study aims to investigate the impact of digital twin technology on the fan manufacturing sector. The proposal for implementing the enabling industry 5.0 application was presented to the chief engineers of eight distinct fan manufacturers. Out of these, five responded positively and their feedback was subsequently followed up on. Three different avenues such as production, supply chain, and testing transparency were proposed for industry 5.0 implementation. The exploration of testing transparency is being undertaken based on a consensual decision. The Web of Things standard that enables digital twin generation in industry 4.0 is implemented to enable the testing transparency. This data was linked with the internal digital twin of fan motor created using ANSYS. This digital twin can predict the lifespan of the motor by analyzing the temperature of the motor housing surface. Toward sustainability and resilience with Industry 4.0 and Industry 5.0 may provide insights into this alignment.

14.
Heliyon ; 10(13): e33882, 2024 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-39050479

RESUMO

3D printing of food materials is among the innovations that could revolutionize people's food choices and consumption. Food innovation and production have advanced considerably in recent years and its market has shown rapid annual expansion. Printing food technologies are considered as a potential solution for producing customized foods such as military food, and astronaut food. The printable food ink material still lacks standardization and superior extrusion process compared to other 3D printing industries. This review paper aimed to provide a comprehensive review of the current foods 3D printing and the latest technology in certain terms and with its concrete applications. In particular, the following issues are discussed: the printing techniques, exudations classes, business prospects, technologies, printing parameters, food materials, safety, and challenges and limitations of food 3D printing along with possible improvement recommendations. Significant printing parameters have been summarized and the safety of the food printing has been evaluated. Moreover, this article also contains a detailed, tabular evaluation of technical approaches employed across researched based and commercially available systems. One of the major limitations that need to be resolved was standardization of food printing safety.

15.
Front Robot AI ; 11: 1406645, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39050485

RESUMO

Educational robots offer a platform for training aspiring engineers and building trust in technology that is envisioned to shape how we work and live. In education, accessibility and modularity are significant in the choice of such a technological platform. In order to foster continuous development of the robots as well as to improve student engagement in the design and fabrication process, safe production methods with low accessibility barriers should be chosen. In this paper, we present Robotont 3, an open-source mobile robot that leverages Fused Deposition Modeling (FDM) 3D-printing for manufacturing the chassis and a single dedicated system board that can be ordered from online printed circuit board (PCB) assembly services. To promote accessibility, the project follows open hardware practices, such as design transparency, permissive licensing, accessibility in manufacturing methods, and comprehensive documentation. Semantic Versioning was incorporated to improve maintainability in development. Compared to the earlier versions, Robotont 3 maintains all the technical capabilities, while featuring an improved hardware setup to enhance the ease of fabrication and assembly, and modularity. The improvements increase the accessibility, scalability and flexibility of the platform in an educational setting.

16.
Adv Colloid Interface Sci ; 332: 103251, 2024 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-39053160

RESUMO

In the domain of photopolymerization-based additive manufacturing (3D vat printing), ceramic photopolymer resins represent a multifaceted composite, predominantly comprising oligomers, ceramic fillers, and photoinitiators. However, the synergy between the ceramic fillers and polymer matrix, along with the stabilization and homogenization of the composite, is facilitated by specific additives, notably surface-active agents, dispersants, and adhesion promoters. Although these additives constitute a minor fraction in terms of volume, their influence on the final properties of the material is substantial. Consequently, their meticulous selection and integration are crucial, subtly guiding the performance and characteristics of the resultant ceramic matrix composites toward enhancement. This review delves into the array of dispersants and coupling agents utilized in the additive manufacturing of ceramic components. It elucidates the interaction mechanisms between these additives and ceramic fillers and examines how these interactions affect the additive manufacturing process. Furthermore, this review investigates the impact of various additives on the rheological behavior of ceramic slurries and their subsequent effects on the post-manufacturing stages, such as debinding and sintering. It also addresses the challenges and prospects in the optimization of dispersants and coupling agents for advanced ceramic additive manufacturing applications.

17.
Allergol Select ; 8: 251-264, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39055748

RESUMO

The availability of high-quality skin test allergens is a prerequisite for the reliable diagnosis of occupational type I allergies. Due to the withdrawal of existing marketing authorizations (MAs) by pharmaceutical companies and the lack of new MAs for commercial test allergens, there is an increasing diagnostic gap in Germany and other EU member states, which makes it necessary to investigate alternative ways of providing in vivo diagnostics. The German Medicinal Products Act (Arzneimittelgesetz = AMG) allows for the possibility of preparing medicinal products in pharmacies without the need for an MA or a manufacturing authorization pursuant to Section 13 (2) No. 1 in conjunction with Section 13 (2a) Sentence 2 No. 3 AMG. This also includes test allergens. In addition to the AMG, the requirements of the German Ordinance on the Operation of Pharmacies (Apothekenbetriebsordnung - ApBetrO) and the European Pharmacopoeia apply in particular. Medicolegal and practical challenges, as well as potentials of manufacturing skin prick test solutions in public pharmacies are presented based on examples of different allergen source materials.

18.
Heliyon ; 10(13): e34037, 2024 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-39055799

RESUMO

Nowadays, this is even more challenging while additive manufacturing technology is used for prototyping, as well as the production of gearing systems. Presented is an optimization and characterization of the additively manufactured (AM) gears made of carbon-reinforced polyamide material in correlation to conventional polymer gearings. Based on the obtained results, the fatigue life data for AM carbon-reinforced Polyamide gears is calculated and compared to traditionally produced Polyamide 66-based gears. Results show that the durability of AM-produced carbon-reinforced Polyamide gears can be compared to conventional-produced Polyamide 66-based gears. Furthermore, deduced that wear of the AM-reinforced Polyamide teeth, can be closely connected with the meshing temperature in correlation with fatigue.

19.
Heliyon ; 10(13): e33959, 2024 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-39055823

RESUMO

Under the impetus of the new industrial revolution, how to realize intelligent manufacturing transformation of traditional pharmaceutical manufacturing enterprises has realistic urgency. The study starts from the perspective of complex adaptive system, constructs a system dynamics model of the evolution mechanism of intelligent manufacturing transformation of pharmaceutical manufacturing enterprises based on technological adaptation and evolutionary adaptation, and analyzes it by simulation using Vensim PLE software. The results of the study show that pharmaceutical manufacturing enterprises utilize technological affordances to provide support to realize network product-based manufacturing capability and smart product-based manufacturing capability through technological innovation capability and institutional optimization capability; the technological affordances environment promotes the realization of intelligent manufacturing transformation of pharmaceutical manufacturing enterprises to present a stage transformation law. The study enriches and extends the research paradigm of intelligent manufacturing transformation, and provides a reference for pharmaceutical manufacturing enterprises to realize intelligent manufacturing transformation.

20.
Eur J Pharm Biopharm ; : 114425, 2024 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-39059751

RESUMO

Monoclonal antibodies (mAbs) encounter numerous interfaces during manufacturing, storage, and administration. While protein adsorption at the solid/liquid interface has been widely explored on model surfaces, a key challenge remains - the detection of very small amounts of adsorbed mAb directly on real medical surfaces. This study introduces a novel ELISA-based device, ELIBAG, a new tool for measuring mAb adsorption on medical bags. The efficacy of this device was highlighted by successfully confirming the adsorption of an IgG1 on two medical bag types: a polypropylene IV administration bag and a low-density polyethylene pharmaceutical manufacturing bag. We also investigated IgG1 adsorption on plastic model surfaces, revealing a similar range of mAb bulk concentration for surface saturation on both model and bag surfaces. This innovative device, characterized by its high-throughput and rapid approach, paves the way for extensive investigations into therapeutic proteins, such as mAbs, adsorption on a variety of medical or pharmaceutical surfaces, diverse adsorption conditions, and the influence of excipients employed in mAb formulation, which could enhance the knowledge of mAb interactions with plastic surfaces throughout their lifecycle.

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