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Nanomedicine and regulatory science: the challenges in Africa 纳米医学和管理科学:非洲的挑战
Pub Date : 2023-11-08 DOI: 10.3389/fbiom.2023.1184662
N. Z. Nyazema, J. T. Chanyandura, P. O. Kumar
The integrated approach in the development of nanotechnology is allowing its introduction into multiple fields, including pharmaceutical research, in which there are now several medicines containing nanomaterials or at least making nano-based claims. As a result of increasing research in nanotechnology, pre-existing medicines have been reformulated, and new medicines have been developed. This has brought challenges to the current regulatory frameworks in Europe and the United States. These regulatory agencies are known to be stringent because they have both the human capacity and skills and conducive policies and the landscape to manage new technology, unlike the agencies in most African countries. Because the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have embraced regulatory science (RS) as a means of proactive analysis of regulatory principles, those agencies will be able to address nanomedicine challenges in a straightforward manner. African countries currently do not have a harmonized regulatory framework because different national regulatory authorities are at different levels of development. The pharmaceutical sector in Africa is facing many challenges, including the non-existence of research and development partnerships between industry, universities, and research institutions that foster nanomedicine development. Now that the African Medicine Agency (AMA) is in place, Africa should see the rapid implementation of the AU Model Law on Medical Products Regulation that will assist in putting in place capacity-building programs in nanomedicine RS.
纳米技术发展中的综合方法正在允许将其引入多个领域,包括药物研究,其中现在有几种药物含有纳米材料,或者至少提出了基于纳米的声明。由于纳米技术研究的增加,已有的药物被重新配制,并且开发了新的药物。这给欧洲和美国目前的监管框架带来了挑战。众所周知,这些管理机构是严格的,因为它们既有人力能力和技能,也有有利的政策和环境来管理新技术,这与大多数非洲国家的机构不同。由于欧洲药品管理局(EMA)和美国食品和药物管理局(FDA)已经接受了监管科学(RS)作为一种对监管原则进行前瞻性分析的手段,这些机构将能够以一种直接的方式解决纳米医学的挑战。非洲国家目前没有统一的管理框架,因为不同的国家管理当局处于不同的发展水平。非洲的制药部门正面临许多挑战,包括产业界、大学和研究机构之间不存在促进纳米药物开发的研究与发展伙伴关系。既然非洲医药局已经成立,非洲应该迅速实施非盟《医疗产品条例示范法》,这将有助于在纳米医学RS方面实施能力建设方案。
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引用次数: 0
In vivo validation of a mechanically adaptive microfluidic intracortical device as a platform for sustained local drug delivery 机械自适应微流体皮质内装置作为持续局部药物递送平台的体内验证
Pub Date : 2023-10-17 DOI: 10.3389/fbiom.2023.1279367
Youjoung Kim, Lindsey N. Druschel, Natalie Mueller, Danielle Sarno, Kaela Gisser, Allison Hess-Dunning, Jeffrey R. Capadona
Introduction: Intracortical microelectrodes (IME) are vital to properly functioning brain-computer interfacing (BCI). However, the recording electrodes have shown a steady decline in performance after implantation, mainly due to chronic inflammation. Compliant materials have been explored to decrease differential strain resulting in lower neural inflammation. We have previously developed a fabrication method for creating mechanically adaptive microfluidic probes made of a cellulose nanocrystal (CNC) polymer nanocomposite material that can become compliant after implantation. Here, we hypothesized that our device, would have a similar tissue response to the industry standard, allowing drug delivery therapeutics to improve neural inflammation in the future. Methods: RNA expression analysis was performed to determine the extent of neural inflammation and oxidative stress in response to the device compared to controls and to naïve shame tissue. Results: Results presented for both four- and eight-weeks post-implantations suggest that our device offers a promising platform technology that can be used to deliver therapeutic strategies to improve IME performance.
简介:皮质内微电极(IME)对于脑机接口(BCI)的正常运作至关重要。然而,记录电极在植入后表现出稳定的性能下降,主要是由于慢性炎症。柔性材料已被探索,以减少差异应变导致较低的神经炎症。我们之前已经开发了一种制造方法,用于制造由纤维素纳米晶体(CNC)聚合物纳米复合材料制成的机械自适应微流体探针,该探针在植入后可以变得柔顺。在这里,我们假设我们的设备,将有一个类似的组织反应的行业标准,允许药物输送治疗,以改善神经炎症在未来。方法:进行RNA表达分析,以确定与对照组和naïve羞耻组织相比,该装置对神经炎症和氧化应激的反应程度。结果:植入后4周和8周的结果表明,我们的设备提供了一个有前途的平台技术,可用于提供改善IME性能的治疗策略。
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引用次数: 0
Unravelling hierarchical patterning of biomaterial inks with 3D microfluidic-assisted spinning: a paradigm shift in bioprinting technologies 用三维微流体辅助纺丝揭开生物材料墨水的分层图案:生物打印技术的范式转变
Pub Date : 2023-10-17 DOI: 10.3389/fbiom.2023.1279061
Sajad Mohammadi, Gianluca Cidonio
For decades, 3D bioprinting has offered a revolutionising approach to combine living cells and biomaterials to engineer complex, yet functional constructs. However, traditional 3D bioprinting platforms fall short of the ability to pattern complex gradients of biomaterials, cells, and ultimately bio-physical properties to drive tissue formation and regeneration. Recently, 3D microfluidic-assisted bioprinting (3DMB) has risen as a new hybrid approach for the fabrication of physiologically relevant tissues, adopting a microfluidic chip as functional printhead to achieve hierarchical patterning of bioinks and precise control over the microscale architecture of printed constructs, enabling the creation of multi-layered tissues. This review explores recent advancements in graded biomaterial patterning using microfluidic-assisted spinning and novel 3D bioprinting technologies. The physiological hierarchical arrangement of human tissues and the crucial role of biomaterials in achieving ordered assembly is hereby discussed. Lastly, the integration of microfluidic-assisted techniques with new bioprinting platforms is highlighted, examining the latest advancements in tissue regeneration and disease modelling.
几十年来,3D生物打印提供了一种革命性的方法,将活细胞和生物材料结合起来,设计出复杂但功能齐全的结构。然而,传统的3D生物打印平台缺乏对生物材料、细胞和最终生物物理特性的复杂梯度进行图案化以驱动组织形成和再生的能力。最近,3D微流控辅助生物打印(3DMB)作为一种新的混合方法兴起,用于制造生理相关组织,采用微流控芯片作为功能打印头,实现生物墨水的分层图案和对打印结构的微尺度结构的精确控制,从而实现多层组织的创建。本文综述了利用微流体辅助纺丝和新型生物3D打印技术在梯度生物材料图图化方面的最新进展。在此讨论人体组织的生理层次排列和生物材料在实现有序组装中的关键作用。最后,强调了微流体辅助技术与新型生物打印平台的集成,研究了组织再生和疾病建模的最新进展。
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引用次数: 0
Ion—modified optimization of smart scaffolds in bone tissue regeneration 离子修饰优化骨组织再生智能支架
Pub Date : 2023-10-11 DOI: 10.3389/fbiom.2023.1289382
Yashas Basavarajappa
Bioactive glasses and Calcium Phosphate bioceramics have emerged as promising scaffold biomaterials for bone tissue engineering. These materials possess inherent osteoinductive properties that work to create a more suitable environment for bone tissue formation. Additionally, these scaffolds exhibit dissolution properties when submerged in physiological fluids in vivo and therefore can release different ions. Incorporating therapeutic ion-modifiers that have independently demonstrated their osteogenic favorability to these scaffolds can further increase environmental suitability. This review discusses the favorable properties of bioactive glasses and Calcium Phosphate bioceramics in the context of Bone Tissue Engineering as well as potential incorporable metal ion-modifiers.
生物活性玻璃和磷酸钙生物陶瓷是骨组织工程中很有前途的生物支架材料。这些材料具有固有的骨诱导特性,可以为骨组织形成创造更合适的环境。此外,这些支架在体内浸泡在生理液体中时表现出溶解特性,因此可以释放不同的离子。将治疗性离子调节剂结合到这些支架中,可以进一步提高其环境适应性,这些治疗性离子调节剂已独立证明其成骨优势。本文综述了生物活性玻璃和磷酸钙生物陶瓷在骨组织工程中的良好性能,以及潜在的可溶金属离子调节剂。
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引用次数: 0
Injectable hydrogel with immobilized BMP-2 mimetic peptide for local bone regeneration. 含固定 BMP-2 拟态肽的可注射水凝胶,用于局部骨再生。
Pub Date : 2022-01-01 Epub Date: 2022-07-22 DOI: 10.3389/fbiom.2022.948493
Kirstene A Gultian, Roshni Gandhi, Kayla DeCesari, Vineeth Romiyo, Emily P Kleinbart, Kelsey Martin, Pietro M Gentile, Tae Won B Kim, Sebastián L Vega

Osteoporosis is a disease characterized by a decrease in bone mineral density, thereby increasing the risk of sustaining a fragility fracture. Most medical therapies are systemic and do not restore bone in areas of need, leading to undesirable side effects. Injectable hydrogels can locally deliver therapeutics with spatial precision, and this study reports the development of an injectable hydrogel containing a peptide mimic of bone morphogenetic protein-2 (BMP-2). To create injectable hydrogels, hyaluronic acid was modified with norbornene (HANor) or tetrazine (HATet) which upon mixing click into covalently crosslinked Nor-Tet hydrogels. By modifying HANor macromers with methacrylates (Me), thiolated BMP-2 mimetic peptides were immobilized to HANor via a Michael addition reaction, and coupling was confirmed with 1H NMR spectroscopy. BMP-2 peptides presented in soluble and immobilized form increased alkaline phosphatase (ALP) expression in MSCs cultured on 2D and encapsulated in 3D Nor-Tet hydrogels. Injection of bioactive Nor-Tet hydrogels into hollow intramedullary canals of Lewis rat femurs showed a local increase in trabecular bone density as determined by micro-CT imaging. The presented work shows that injectable hydrogels with immobilized BMP-2 peptides are a promising biomaterial for the local regeneration of bone tissue and for the potential local treatment of osteoporosis.

骨质疏松症是一种以骨矿物质密度下降为特征的疾病,从而增加了发生脆性骨折的风险。大多数医学疗法都是全身性的,不能在需要的部位恢复骨骼,从而导致不良的副作用。本研究报告了一种含有骨形态发生蛋白-2(BMP-2)多肽模拟物的可注射水凝胶的开发情况。为了制造可注射的水凝胶,透明质酸被降冰片烯(HANor)或四氮嗪(HATet)改性,混合后点击成共价交联的 Nor-Tet 水凝胶。通过用甲基丙烯酸酯(Me)修饰 HANor 大分子,硫醇化的 BMP-2 拟态肽通过迈克尔加成反应被固定到 HANor 上,并用 1H NMR 光谱证实了耦合。在二维和三维 Nor-Tet 水凝胶中培养的间充质干细胞中,以可溶和固定形式呈现的 BMP-2 肽增加了碱性磷酸酶(ALP)的表达。将生物活性 Nor-Tet 水凝胶注入 Lewis 大鼠股骨的空心髓内管后,显微 CT 成像显示局部骨小梁密度有所增加。这项研究表明,固定了 BMP-2 肽的可注射水凝胶是一种很有前景的生物材料,可用于局部骨组织再生和潜在的局部骨质疏松症治疗。
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引用次数: 0
Bio-Inspired Materials 仿生材料
Pub Date : 2019-04-10 DOI: 10.2174/97898114068981190601
U. T. Bezerra, H. S. Ferreira, N. P. Barbosa, A. Manzano-Ramírez, A. Nobrega, Benedikt Demmert, Corinna F. Böhm, Eng. Kai Li, Eng. Piet Stroeven, G. Rzevski, Jose Augusto Gomes Neto, J. L. R. Araiza, K. Ghavami, Mario Villalón, M. Phocas, Martina Schüßler, Niki Georgiou, O. Kontovourkis, Sandra Patricia Reyes Ortiz, S. Wolf, Theofilo Barreto Moreira Oliveira, V. Stabnikov, V. Ivanov
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引用次数: 0
Bio-inspired Design with Bamboo 竹子的仿生设计
Pub Date : 2019-04-10 DOI: 10.2174/9789811406898119060009
N. P. Barbosa, Jose Augusto Gomes Neto, Sandra Patricia Reyes Ortiz, K. Ghavami
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引用次数: 0
Bio-Pulse Oscillations Driven Design of Kinetic Structures 生物脉冲振荡驱动的动力结构设计
Pub Date : 2019-04-10 DOI: 10.2174/9789811406898119060003
M. Phocas, O. Kontovourkis, Niki Georgiou
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引用次数: 0
Sustainable and Safe Construction Biomaterials: Biocements and Biogrouts 可持续和安全的建筑生物材料:生物水泥和生物灌浆
Pub Date : 2019-04-10 DOI: 10.2174/9789811406898119060011
V. Ivanov, V. Stabnikov
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引用次数: 3
Interaction Between Natural Fibres and Synthetic Polymers 天然纤维与合成聚合物的相互作用
Pub Date : 2019-04-10 DOI: 10.2174/9789811406898119060012
A. Manzano-Ramírez, Mario Villalón, J. L. R. Araiza
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引用次数: 0
期刊
Frontiers in biomaterials science
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