The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo.
Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks.

开始日期2024-03-01

申办/合作机构-

CTRI/2024/02/062402 / Not yet recruiting临床2期

Pharmacokinetic Study of Palmitoylethanolamide (PEA) Extract in Healthy Human Volunteers. - Nil

开始日期2024-02-16

申办/合作机构

Tilman SA

CTRI/2023/09/057856 / CompletedN/A

A multi-centre, double-blind, randomized, three-arm, interventional, parallel, placebo-controlled study to evaluate the efficacy, safety and tolerability of Palmitoylethanolamide in subjects with symptoms of kneeosteoarthritis. - NIL

开始日期2023-09-25

申办/合作机构

Bio-gen Extracts Pvt Ltd.

100 项与帕米醇相关的临床结果

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100 项与帕米醇相关的转化医学

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100 项与帕米醇相关的专利（医药）

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1,536

项与帕米醇相关的文献（医药）

2024-06-01·Food chemistry

Phenylethylamine sensing at the electrified liquid–liquid interface. Can electrochemistry be used to follow the UHT milk spoilage process?

Article

作者: Skrzypek, Sławomira ; Karpiński, Robert ; Rudnicki, Konrad ; Borgul, Paulina ; Powałka, Emilia ; Poltorak, Lukasz ; Sobczak, Karolina

This study involved an investigation into the electrochemical characteristic of a few biogenic amines (BAs) occurring at the polarized interface between two immiscible electrolyte solutions (ITIES) with ion transfer voltammetry (ITV). The main focus of this research was the comprehensive electroanalytical and physicochemical analysis of phenylethylamine (PEA), allowing the determined of the formal Galvani potential of the ion transfer reaction (Δ_org^aqΦ^'), diffusion coefficients (D), formal free Gibbs energy of the ion transfer reaction (ΔG^'aq→org) and water-1,2-dichloroethane partition coefficient (logP_water/DCE^PEA). Furthermore, the collected data were employed to calculate analytical parameters, including voltametric detection sensitivity, limits of detection and the target analyte quantification. Moreover, the influence of the presence of 7 other BAs (histamine, spermine, spermidine, putrescine, cadaverine, tyramine and tryptamine) on the recorded signals originating from the PEA ion transfer was checked. The feasibility of the developed method was corroborated through experimentation with milk samples. Additionally, utilizing the devised methodology, an electrochemical assessment of the spoilage progression in milk samples was undertaken.

2024-02-01·Journal of texture studies

Sensory properties of thickened tomato soup enhanced with different sources of protein (whey, soy, hemp, and pea)

Article

作者: McSweeney, Matthew B ; Dabas, Tanvi ; Gorman, Mackenzie ; Moss, Rachael ; Amyoony, Jamal

Abstract:

Thickened soup formulations were created with different proteins (hemp, soy, pea, and whey) to improve protein and fluid intake. The formulations consisted of a control soup, and soups with 6% whey protein, 6% hemp protein, 6% pea protein, and 6% soy protein by volume. The suitability of the samples for those living with dysphagia was evaluated using the international dysphagia diet standardization initiative (IDDSI) spoon tilt test and a sensory trial (51 older adults and 51 younger adults). The sensory trial used nine‐point hedonic scales and check‐all‐that‐apply to evaluate the different formulations. The sample with the whey addition was not significantly different than the control in terms of liking of flavor and texture, but it decreased the participants' overall liking. The hemp, pea, and soy decreased overall liking as well as liking of flavor and texture. They were associated with off‐flavors, aftertaste, and astringency. The responses from the older and younger adults were compared and significant differences were found in their liking of the texture, with the older adults finding the formulations' texture significantly more acceptable. Overall, the study identified that hemp, pea, and soy did not create acceptable thickened soup formulations and the hemp and pea formulations did not achieve a consistency level that is acceptable for those living with dysphagia.

2024-02-01·Current opinion in otolaryngology & head and neck surgery

Infectious disease for the rhinologist

Review

作者: Ng, Dorothy Hui Lin ; Png, Lu Hui ; Teo, Neville Wei Yang

Purpose of review:

The purpose of this review is to summarize the recent literature relating to viral, fungal and bacterial infections and their interactions within the sinonasal tract in the past 18 months.

Recent findings:

Coronavirus disease 2019 (COVID-19)-associated olfactory dysfunction (OD) is variant dependent. Magnetic resonance imaging studies have found greater olfactory cleft opacification and higher olfactory bulb volume in post-COVID-19 OD. Olfactory training remains the mainstay of treatment, while platelet-rich plasma injections and ultramicronized palmitoylethanolamide and luteolin combination oral supplementation have shown early promise.Consensus statements on paranasal sinus fungal balls and acute invasive fungal sinusitis have been released.Studies on the nasal microbiome have reported Staphylococcus and Corynebacterium as the most abundant genera, with higher levels of Staphylococcus and Corynebacterium being found in patients with chronic rhinosinusitis (CRS) and healthy individuals respectively. However, there is conflicting evidence on the significance of biodiversity of the nasal microbiome found in CRS versus healthy patients.

Summary:

While the peak of the COVID-19 pandemic is behind us, its sequelae continue to pose treatment challenges. Further studies in OD have implications in managing the condition, beyond those afflicted post-COVID-19 infection. Similarly, more research is needed in studying the nasal microbiome and its implications in the development and treatment of CRS.

100

项与帕米醇相关的新闻（医药）

2024-05-19

·生物制品圈

先进的PAT如何通过数字设计提升mRNA制造的质量

通过数字设计实现质量（QbDD）是对设计中的质量（QbD）范式的改进。在这里，计算模型被用来表征、监控、控制和改进制造过程。这些计算模型的实现方式包括数字孪生（DT）和软传感器。这些模型可用于广泛的活动，包括但不限于测量系统状态变量、辅助流程开发、冗余传感器、高级流程控制（预测控制）和实时流程优化。然而，QbDD的实施依赖于流程数据的数量和质量。此外，数据采集需要实时进行，并应提供计算模型与控制组件之间的通信。流程分析技术（PAT）为实际制造过程与计算模型之间提供了至关重要的接口。高级PAT在实施制造过程的实时监控和控制方面至关重要。当与多产品制造平台技术（如mRNA平台）结合使用时，QbDD尤其强大。mRNA制造平台的现状mRNA制造平台仍处于发展阶段，缺乏某些成熟生物制造过程的PAT工具。分析大多是离线或在线的，缺乏有意义的实时监控或控制。然而，随着对基于mRNA产品需求的增长，建立一个健全的平台制造系统的需求日益强烈。关键过程参数（CPPs），如pH值、离子强度和温度，在mRNA产品制造期间可以被监控和控制。然而，为了改善特定的关键质量属性（CQAs）和关键绩效指标（KPIs），监控和控制底层反应动力学是必要的。基于荧光的和在线高效液相色谱法（HPLC）的方法已被用于监测体外转录反应，并提供一些近实时监控和控制。同样，基于紫外吸收的监测是下游纯化策略的一个组成部分。然而，一套新提出的传感器，如近红外（NIR）和拉曼光谱，可能会提供更多关于底物利用（核糖核苷酸转化为mRNA）、不同反应组分（核糖核苷酸、mRNA、RNA聚合酶、Mg2+）的实时监测以及可能的过程和产品相关杂质（免疫原性dsRNA）的检测。挑战：高级PAT的实施受到缺乏专用传感器或在某些情况下，适当分析可用传感器生成的数据的限制。与传统的化学合成不同，像mRNA制造这样的生物过程生成难以获取和分析的高维数据。此外，在分析完成后，需要在开发的计算模型和制造控制组件（包括执行器）之间进行稳健的通信，以实现实时流程控制。mRNA制造为何重要？在SARS-CoV2大流行期间，两种批准的基于mRNA的疫苗的成功之后，基于mRNA的产品在其潜在应用中看到了急剧增加。除了在预防性疫苗中的应用外，它们也被视为潜在的治疗方式。对mRNA产品的研究与开发以及临床试验的财政投资增加，证明了该领域未来增长的证据。mRNA制造中的QbD和QbDD方法为了满足日益增长的需求，制造基于mRNA的产品需要一个良好表征的、稳健且可靠的过程。与其它生物制药制造过程类似，QbD方法可以为构建平台mRNA制造系统提供基础。QbD方法从基于患者需求定义质量目标产品档案（QTPP）开始。随后，根据风险评估确定产品的特定CQAs，为每个质量属性提供严重程度得分，以确保患者安全和产品效力。此外，CPPs在制造过程中对已识别的CQAs和KPIs的影响被映射和量化，以降低整体风险并提高产品质量。基于CQAs和CPPs之间的相互作用的制造设计空间有助于建立CPPs的最佳范围，这些范围对应于预定质量和监管限制内的CQAs。通过在经过验证的设计空间内运行流程，QbD方法确保质量融入产品而不仅仅是在产品制造后进行测试。此外，只要保持最初批准的设计空间，QbD方法还有助于监管机构批准未来与流程相关的变更。QbD的一个改进是数字设计中的质量方法，它利用先进的计算模型来映射和分析CQA-CPP相互作用。在QbDD范式中创建的计算模型用于高级过程监控和过程控制。软传感器和数字孪生等数字工具对QbDD方法至关重要。与常规的QbD方法不同，QbDD方法在很大程度上依赖于来自制造过程的数据的质量和数量。来自制造过程的大量数据用于计算模型的初始开发，并且为了它们的后续部署，需要来自流程的稳定数据流，以实现实时过程监控和控制。PAT是物理制造过程和QbDD范式中使用的数字工具之间的接口。QbDD和平台mRNA制造的现状目前，mRNA制造过程遵循与其他传统生物制药类似的批处理模式。整体制造可以分为模板制造、药物物质制造、药物产品制造和填充/完成操作。图1展示了mRNA制造过程及其相关单元操作。图1 _展示了mRNA制造系统的示意图。整体制造被划分为模板制造、药物物质制造（mRNA合成和纯化）、药物产品制造（配制的基于mRNA的产品）和填充完成操作（大部分外包）。模板和药物物质制造药物物质制造侧重于mRNA合成（尽管在某些情况下，模板DNA合成也包括在这一步中）。mRNA合成是通过一种称为体外转录（IVT）的无细胞酶促过程完成的；在这里，mRNA从模板DNA转录而来，使用RNA聚合酶（酶）和核糖核苷酸（底物）以及其他反应组分。反应通常在37摄氏度的最佳温度下进行，时间在1到4小时之间。用于转录mRNA的模板DNA可以通过多种方式合成，包括PCR扩增、质粒DNA扩增（结合线性化步骤）或酶促合成（例如，狗骨头DNA）。IVT反应已经深入研究，提出了多种机理、数据驱动和混合模型，以监测和预测系统状态变量，确保所需的质量和过程控制。在IVT阶段通常监测的过程参数包括过程温度、pH值和底物浓度。有意义的实时监控和控制可能仅限于过程温度和pH值。参与这个单元操作的PAT可能来自其他生物制造过程，包括但不限于微生物发酵和动物细胞培养。底物监测已有报道，但充其量仍然是近实时过程监控和控制的选项。从IVT阶段合成的mRNA的纯化通常是通过切向流过滤和不同类型的色谱（离子交换、尺寸排除、多模式或亲和色谱）来实现的；单元操作的顺序取决于制造商，但这两种技术都被广泛采用。纯化过程将合成的mRNA转化为药物物质/活性药物成分。在纯化阶段使用的PAT主要监测单元操作前后API的浓度。对于mRNA纯化，通常使用过程输出的紫外吸收来定量mRNA浓度。这种测量通常使用探针或流动池基传感器进行。基于紫外吸收的定量的经典限制在于它不能区分mRNA和合成阶段未使用的核糖核苷酸（过程杂质）。这种限制可以通过HPLC、毛细管电泳和质谱等先进的分析技术来克服。然而，这些先进的分析技术通常没有与制造过程集成，这些技术的反馈不能用于控制过程。药物产品制造基于mRNA的产品主要是为了促进其生物摄取（大的带负电荷的mRNA分子穿过脂质双层的摄取）并提高药物产品的整体功能。mRNA与脂质或其他转染剂一起配制，其中最广泛研究的包括脂质纳米颗粒（LNPs）、阳离子纳米乳液（CNEs）、阳离子肽和聚合物。LNPs在两种批准的SARS CoV2疫苗的配制中被使用，可以通过微流体学或注射方法制备。这些过程稳健，可以成功地扩大规模，生产出一致的产品。在任一过程中，含有mRNA的水相与含有脂质的有机相混合，以生产封装mRNA的LNP。封装效率、LNP大小、LNP多分散性、LNP表面电荷、纯度和稳定性等CQAs需要在产品发布前进行分析。这些大多数CQAs的实时监测很困难，用于它们分析的技术太复杂，无法集成到制造系统中。像动态光散射（DLS）这样的新方法已经找到了一些应用，但尚未建立。CPPs，如过程温度和pH值，只成功实现了实时监控和控制。填充/完成和存储操作最终产品的填充/完成要么在相同的制造和配制设施中完成，要么外包给专门的填充/完成设施。这些步骤中的过程监控和控制是从其他生物制药填充/完成操作中采用的，因此，与其他单元操作相比，它们更加成熟。分配产品的均匀性是这个阶段需要考虑的最重要的因素。产品CQAs也受到暴露于高温和添加任何与过程相关的杂质的影响。产品还暴露于剪切应力，这可能对产品质量构成挑战。最后，填充的产品需要被存储，其温度必须被监控，以检测和避免因暴露于高温而导致的产品降解。高级PAT在mRNA制造中的应用评估现状，很明显在mRNA制造空间内各种单元操作的PAT开发存在滞后，这不利于QbDD的实施。来自其他生物制药制造的传统PAT在一定程度上是有用的，但它无法弥合当前制造过程与生物加工4.0所需的过程之间的差距。即使是用于各种核酸分析的复杂分析技术（如质谱、RT-PCR、RP-HPLC等）也有离线或在线传感器的缺点，从而减少了对控制和改进过程的实时反馈。生物制药行业的更广泛趋势是朝着更多的流程自动化和实施QbD发展，而不是由质量测试（QbT）支持的传统制造。与任何其他生物制造一样，mRNA制造的杰作将是一个良好表征的、良好监控的、自动化的、连续的过程。如果在整个制造过程中，包括最终存储，测量API和配制产品的CQAs，就可以实现这一目标。实施高级PAT对于开发和部署软传感器和数字孪生至关重要，这些工具对于高级过程监控和控制至关重要。图2展示了PAT在mRNA制造中更广泛实施QbDD的作用。图2 _数字设计中的质量（QbDD）方法应用于平台mRNA制造系统。它使用计算模型开发高级监控和过程控制策略（使用软传感器和数字孪生）。在这种情况下，PAT对于过程数据收集和分析以及控制器和设备之间的通信至关重要。传感器技术的进步及其在mRNA制造中的应用正在发生明确的变化。能够更好地监测mRNA领域特定CQAs的传感器正在得到必要的关注，并且正在部署在制造过程的药物物质和药物产品方面。在线HPLC已被研究用于监测IVT过程中的核糖核苷酸浓度，并提高总体产量。PAT通过过渡到进料批处理模式，帮助提高了反应产量。信息以近实时速度收集，并用于添加正在反应中耗尽的底物。文献报道，使用这种方法可以获得高达12 g/L的产品产量，这只需要已经建立的分析技术。尽管该技术使用基于紫外吸收的光谱来估计产品和底物浓度，但HPLC方法有助于将产品与底物分离，并量化维持反应条件向产品形成所需的底物量。该技术为底物利用提供了更好的见解，并有助于模型开发，这是QbDD方法中的关键步骤。基于传统PAT的代理软传感器也可以帮助QbDD工具的开发；这样的情景的一个例子是使用pH探头监测反应动力学并创建反馈以添加底物。此外，传统PAT的进步也有助于实时数据收集和与控制器模块的通信，以维护一个健全的制造空间。UV-Vis光谱分析也是代理分析反应混合物的候选者。这些可以用来估计系统状态变量，如底物浓度和产品/过程相关杂质。通过添加某些荧光团对反应混合物进行轻微修改也已报道用于监测动力学。荧光共振能量转移（FRET）对反应混合物的这些修改不会影响产品的CQAs，同时促进了已经使用的PAT的使用，这对减少基于以前未使用技术的新型PAT的挑战非常有益。荧光共振能量转移（FRET）被证明能够使用已经可用的荧光探测器实时监测IVT反应。除了已经建立的UV-Vis和荧光光谱分析，拉曼和红外光谱也作为可能的mRNA制造PAT越来越受到关注。基于NIR和拉曼光谱NIR和拉曼光谱提供了反应组分的分子指纹，并且可以提供更多关于底物利用（核糖核苷酸转化为mRNA）、不同反应组分（核糖核苷酸、mRNA、RNA聚合酶、Mg2+）的实时监测以及可能的过程和产品相关杂质（免疫原性dsRNA）的检测的信息。这些光谱分析的优点包括在不需要额外的采样或样品准备的情况下区分产品和底物。从理论上讲，拉曼和红外光谱对于反应混合物的每个组分都是独特的。因此，它们应该理想地用于监测反应进展和检测过程/产品相关杂质。此外，上述较新的PAT与其在生物制造中的更广泛应用相兼容，适用于mRNA制造的药物物质和药物产品阶段。实施高级PAT的挑战实施高级PAT受到缺乏专用传感器或在某些情况下，适当分析可用传感器生成的数据的限制。与传统的化学合成不同，像mRNA制造这样的生物过程生成难以获取和分析的高维数据。像软传感器和DT这样的数字工具使用不同类型的计算模型来分析来自PAT的数据。建立在质量平衡或反应动力学基础上的机理模型是稳健的，并且能够进行外推，但它们相对更难开发并且计算复杂（导致实时反馈的滞后）。数据驱动模型是黑箱，完全依赖于过程数据，并且在模型输入-输出变量空间内是稳健的（主要能够进行插值）。然而，这些模型通常比机理模型更快。机理模型和数据驱动模型（混合模型）的融合互补彼此的优势并减轻固有缺陷，使它们更适合于快速分析来自高级PAT的复杂数据。此外，为了实现实时过程控制，开发计算模型与制造控制组件之间的通信需要稳健。数据可以通过人机界面（HMI）手动获取，也可以通过自动化的机机接口（MMI）方法获取。更广泛地采用MMI标准，如开放平台通信（OPC）和OPC统一架构，对于开发和实施新的监控和控制策略至关重要。结论随着未来几年需求的增长，基于mRNA的产品无疑将需要一个良好表征且稳健的制造过程。与其它生物制药制造一样，生物过程4.0的原则和更广泛的数字化趋势将影响这一制造过程的发展。实施QbDD对于生产高质量的产品、遵守监管要求和获得更快的监管批准至关重要。在建立这样一个自动化过程的宏伟计划中，PAT的作用变得比以往任何时候都更加重要。传感器技术、计算模型和机器对机器通信协议的标准化的进步需要协同作用，以实现mRNA制造的数字化。作者：Adithya Nair博士和Zoltán Kis博士，谢菲尔德大学生物化学工程系参考文献:Dutt D, Mazzucato M, Torreele E An mRNA technology transfer programme and economic sustainability in health care. Bulletin of the World Health Organization; Type: Policy & practice 2024.Qin S, Tang X, Chen Y, et al (2022) mRNA-based therapeutics: powerful and versatile tools to combat diseases. Signal Transduction and Targeted Therapy 2022 7:1 7:1–35. https://doi-org.libproxy1.nus.edu.sg/10.1038/s41392-022-01007-wDamase TR, Sukhovershin R, Boada C, et al (2021) The Limitless Future of RNA Therapeutics. Front Bioeng Biotechnol 9:628137. https://doi-org.libproxy1.nus.edu.sg/10.3389/FBIOE.2021.628137U.S. FDA (2009) Guidance for Industry: ICH Q8(R2) Pharmaceutical Development. Workshop: Quality by Design in pharmaceuticalRathore AS, Winkle H (2009) Quality by design for biopharmaceuticals. Nature Biotechnology 2009 27:1 27:26–34. https://doi-org.libproxy1.nus.edu.sg/10.1038/nbt0109-26Daniel S, Kis Z, Kontoravdi C, Shah N (2022) Quality by Design for enabling RNA platform production processes. Trends Biotechnol 40:1213–1228Daniel S, Kis Z, Kontoravdi C, Shah N (2022) A blueprint for quality by digital design to support rapid RNA vaccine process development, manufacturing & supply. Vaccine Insights 01:219–233. https://doi-org.libproxy1.nus.edu.sg/10.18609/VAC.2022.33Chen Y, Yang O, Sampat C, et al (2020) Digital Twins in Pharmaceutical and Biopharmaceutical Manufacturing: A Literature Review. Processes 2020, Vol 8, Page 1088 8:1088. https://doi-org.libproxy1.nus.edu.sg/10.3390/PR8091088Glassey J, Gernaey K V., Clemens C, et al (2011) Process analytical technology (PAT) for biopharmaceuticals. Biotechnol J 6:369–377. https://doi-org.libproxy1.nus.edu.sg/10.1002/BIOT.201000356Rosa SS, Prazeres DMF, Azevedo AM, Marques MPC (2021) mRNA vaccines manufacturing: Challenges and bottlenecks. Vaccine 39:2190–2200. https://doi-org.libproxy1.nus.edu.sg/10.1016/J.VACCINE.2021.03.038M.J. Tymms, In Vitro Transcription and Translation Protocols, In Vitro Transcription and Translation Protocols (1995). https://doi-org.libproxy1.nus.edu.sg/10.1385/0896032884.Beckert B, Masquida B (2011) Synthesis of RNA by in vitro transcription. Methods Mol Biol 703:29–41. https://doi-org.libproxy1.nus.edu.sg/10.1007/978-1-59745-248-9_3Karbowniczek K, Rothwell P, Extance J, et al (2017) DoggyboneTM DNA: an advanced platform for AAV production. Cell Gene Ther Insights 3:731–738. https://doi-org.libproxy1.nus.edu.sg/10.18609/cgti.2017.074Brunelle JL, Green R (2013) In vitro transcription from plasmid or PCR-amplified DNA. In: Methods in Enzymology. Academic Press Inc., pp 101–114Analytical Procedures for mRNA Vaccine Quality (Draft Guidelines)- 2nd Edition | USP-NF. https://www.uspnf.com/notices/analytical-procedures-mrna-vaccines-20230428.Skok J, Megušar P, Vodopivec T, et al (2022) Gram-Scale mRNA Production Using a 250-mL Single-Use Bioreactor. Chem Ing Tech 94:1928–1935. https://doi-org.libproxy1.nus.edu.sg/10.1002/cite.202200133Rosa SS, Prazeres DMF, Azevedo AM, Marques MPC (2021) mRNA vaccines manufacturing: Challenges and bottlenecks. Vaccine 39:2190–2200. https://doi-org.libproxy1.nus.edu.sg/10.1016/J.VACCINE.2021.03.038Welbourne EN, Loveday KA, Nair A, et al (2024) Anion exchange HPLC monitoring of mRNA in vitro transcription reactions to support mRNA manufacturing process development. Front Mol Biosci 11: https://doi-org.libproxy1.nus.edu.sg/10.3389/fmolb.2024.1250833Ramachandran S, Satapathy SR, Dutta T (2022) Delivery Strategies for mRNA Vaccines. Pharmaceut Med 36:11–20. https://doi-org.libproxy1.nus.edu.sg/10.1007/S40290-021-00417-520.Blakney AK, McKay PF, Yus BI, et al (2019) Inside out: optimization of lipid nanoparticle formulations for exterior complexation and in vivo delivery of saRNA. Gene Therapy 2019 26:9 26:363–372. https://doi-org.libproxy1.nus.edu.sg/10.1038/s41434-019-0095-2Streck S, Hong L, Boyd BJ, McDowell A (2019) Microfluidics for the Production of Nanomedicines: Considerations for Polymer and Lipid-based Systems. Pharm Nanotechnol 7:423–443. https://doi-org.libproxy1.nus.edu.sg/10.2174/2211738507666191019154815Mirasol F (2021) Meeting Fill/Finish Challenges for COVID-19 Vaccines. Pharmaceutical Technology 2021 Supplement: s22–s23, s28–s22–s23, s28Rathore AS, Nikita S, Jesubalan NG (2022) Digitization in bioprocessing: The role of soft sensors in monitoring and control of downstream processing for production of biotherapeutic products. Biosens Bioelectron X 12:100263. https://doi-org.libproxy1.nus.edu.sg/10.1016/J.BIOSX.2022.100263Helgers H, Hengelbrock A, Schmidt A, Strube J (2021) Digital Twins for Continuous mRNA Production. Processes 2021, Vol 9, Page 1967 9:1967. https://doi-org.libproxy1.nus.edu.sg/10.3390/PR9111967Pregeljc D, Skok J, Vodopivec T, et al (2023) Increasing yield of in vitro transcription reaction with at-line high pressure liquid chromatography monitoring. Biotechnol Bioeng 120:737–747. https://doi-org.libproxy1.nus.edu.sg/10.1002/bit.28299Lee KH, Song J, Kim S, et al (2023) Real-time monitoring strategies for optimization of in vitro transcription and quality control of RNA. Front Mol Biosci 10:1229246. https://doi-org.libproxy1.nus.edu.sg/10.3389/FMOLB.2023.1229246Li Z, Guo H, Xu F, et al (2019) Sensitive monitoring of RNA transcription by optical amplification of cationic conjugated polymers. Talanta 203:314–321. https://doi-org.libproxy1.nus.edu.sg/10.1016/J.TALANTA.2019.05.052Matuszczyk JC, Zijlstra G, Ede D, et al (2023) Raman spectroscopy provides valuable process insights for cell-derived and cellular products. Curr Opin Biotechnol 81:102937. https://doi-org.libproxy1.nus.edu.sg/10.1016/J.COPBIO.2023.102937Thakur G, Masampally V, Kulkarni A, Rathore AS (2022) Process Analytical Technology (PAT) Implementation for Membrane Operations in Continuous Manufacturing of mAbs: Model-Based Control of Single-Pass Tangential Flow Ultrafiltration. AAPS Journal 24:1–10. https://doi-org.libproxy1.nus.edu.sg/10.1208/S12248-022-00731-ZGaddem MR, Kim J, Matsunami K, et al (2024) Roles of mechanistic, data-driven, and hybrid modeling approaches for pharmaceutical process design and operation. Curr Opin Chem Eng 44:101019. https://doi-org.libproxy1.nus.edu.sg/10.1016/J.COCHE.2024.101019Schmidt A, Helgers H, Lohmann LJ, et al (2022) Process analytical technology as key-enabler for digital twins in continuous biomanufacturing. Journal of Chemical Technology and Biotechnology 97:2336–2346 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

信使RNA疫苗

2024-04-10

·GlobeNewswire-Health Care

Clearmind Medicine Files U.S. Patent Application for Psychedelic-Based Treatment for Eating Disorders

Vancouver, Canada, April 10, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "company"), a clinical- stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announced that it has filed a patent application with United States Patent and Trademark Office (USPTO) for the use of 3-methylmethcathinone (with the chemical name 2-(methylamino)-1-(3-methylphenyl)-1-propanon) (“3-MMC”), to prevent and/or treat eating disorders either alone or in conjunction with Palmitoylethanolamide (“PEA”). “The field of weight loss has been a blockbuster of the pharmaceutical industry and generates billions of dollars to companies who are active in this space. We at Clearmind have made it our goal to be at the forefront of developments in fields where we believe that we have an advantage over the marketed treatments, with weight loss being one of them. With sort in supply, shortage of active ingredients, high price, adverse events and inconvenient method of administration, we believe that our molecules may have the potential over the ones already available “ A report by the World Obesity Federation, predicts that half the world will be overweight or obese by 2035. The report authors say this increase could put a strain on healthcare systems and cause $4 trillion in economic damage. About Clearmind Medicine Inc. Clearmind is a clinical- stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements. The Company’s intellectual portfolio currently consists of sixteen patent families. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio. Shares of Clearmind are listed for trading on Nasdaq under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol “CWY0.” For further information visit: https://www.clearmindmedicine.com or contact: Investor Relations invest@clearmindmedicine.com Telephone: (604) 260-1566 US: CMND@crescendo-ir.com General Inquiries Info@Clearmindmedicine.com www.Clearmindmedicine.com Forward-Looking Statements: This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses its goal to be at the forefront of developments in fields where it believes that is has an advantage over the marketed treatments, with weight loss being one of them, and its belief that its molecules may have the potential over the ones already available. The Company cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to the Company. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2023 filed with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

2024-03-27

·GlobeNewswire-Health Care

Clearmind Medicine Announces International Patent Application for Preventing and Treating Depression

Vancouver, Canada, March 27, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY) (“Clearmind” or the “company”), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announced that it has submitted its tenth patent application under the international Patent Cooperation Treaty (“PCT”), as part of its ongoing collaboration with SciSparc Ltd. (Nasdaq: SPRC) (“SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system. The patent applications refer to the novel proprietary composition of Clearmind’s MEAI compound (5-methoxy-2-aminoindane) with Palmitoylethanolamide (“PEA”), the active ingredient of SciSparc’s proprietary CannAmide™, for preventing and/or treating depression. This application was previously filed as provisional patent application with the United States Patent and Trademark Office (“USPTO”). According to the ResearchAndMarkets.com, the global depression and anxiety disorders treatment market size was estimated to be USD 21.56 billion in 2023 and is expected to reach at USD 41.83 billion by 2034 with a CAGR of 6.21% during the forecast period 2024-2034. Overall, as part of this collaboration, nine other patent applications have been filed by Clearmind with the USPTO for various compositions, including the composition of SciSparc’s PEA with Clearmind’s MEAI compound for the treatments of alcohol use disorder, cocaine addiction and obesity and its related metabolic disorders. "We believe that traditional pharma has not taken an innovative approach to R&D as we have seen little innovation to SSRI's (selective serotonin reuptake inhibitors) and other anti-depressants in over 30 years. Under our collaboration with SciSparc, we believe that our proprietary drugs can positively impact patients dealing with various forms of depression including treatment resistant depression," stated Dr. Adi Zuloff-Shani, CEO of Clearmind. "We further believe that we have a tremendous opportunity to develop viable alternatives to the current SSRIs for individuals living with depression. We continue to execute our intellectual property strategy, to develop novel psychedelic drugs to address unmet mental health needs" continued Dr. Zuloff-Shani. About Clearmind Medicine Inc. Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements. The Company’s intellectual portfolio currently consists of fifteen patent families. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio. Shares of Clearmind are listed for trading on Nasdaq under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol “CWY.” For further information visit: https://www.clearmindmedicine.com or contact: Investor Relationsinvest@clearmindmedicine.comTelephone: (604) 260-1566US: CMND@crescendo-ir.com General InquiriesInfo@Clearmindmedicine.comwww.Clearmindmedicine.com Forward-Looking Statements: This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company I s using forward-looking statements when it discusses its belief that it has a tremendous opportunity to develop viable alternatives to the current SSRIs for individuals living with depression and that it continues to execute its intellectual property strategy, to develop novel psychedelic drugs to address unmet mental health needs. The Company cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to the Company. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2023 filed with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

专利到期

100 项与帕米醇相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08328	帕米醇	J	DB14043

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
呼吸道感染	-	-	-

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性肌肉骨骼疼痛	临床2期	美国	FSD Pharma, Inc.	2023-01-19
慢性肌肉骨骼疼痛	临床2期	加拿大	FSD Pharma, Inc.	2023-01-19
慢性疼痛	临床2期	美国	FSD Pharma, Inc.	2023-01-19
慢性疼痛	临床2期	加拿大	FSD Pharma, Inc.	2023-01-19
中链酰基辅酶A脱氢酶缺乏症	临床2期	美国	FSD Pharma, Inc.	2023-01-19
中链酰基辅酶A脱氢酶缺乏症	临床2期	加拿大	FSD Pharma, Inc.	2023-01-19
特发性肥大细胞活化综合征	临床2期	美国	FSD Pharma, Inc.	2023-01-19
特发性肥大细胞活化综合征	临床2期	加拿大	FSD Pharma, Inc.	2023-01-19
化疗引起的损伤	临床2期	美国	National Cancer Institute	2022-05-16
血液肿瘤	临床2期	美国	National Cancer Institute	2022-05-16

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESMO2022	N/A	炎症	-	Palmitoylethanolamide	鏇鹽築鬱廠網繭鬱膚齋(鏇鑰鹽襯繭壓醖襯構願) = 簾艱鬱艱願憲壓獵鏇簾願餘憲窪選艱鹹鹹憲齋 (憲鏇觸願艱夢鹽鏇膚淵 )	-	2022-09-10
				Doxorubicin and trastuzumab	鏇鹽築鬱廠網繭鬱膚齋(鏇鑰鹽襯繭壓醖襯構願) = 積觸鑰鏇製顧夢齋壓願願餘憲窪選艱鹹鹹憲齋 (憲鏇觸願艱夢鹽鏇膚淵 )
ESC2021	N/A	-	-	Palmitoylethanolamide combined with polydatin	鑰齋顧構蓋夢遞繭顧遞(選醖鹽遞網選壓鑰淵遞) = 廠築簾齋蓋顧淵鏇鹽遞願醖鏇衊壓淵齋夢餘觸 (積糧夢鏇簾糧齋廠獵鑰 )	-	2021-06-29
				palmitoylethanolamide	鑰齋顧構蓋夢遞繭顧遞(選醖鹽遞網選壓鑰淵遞) = 衊淵艱鑰襯壓鏇鏇鑰獵願醖鏇衊壓淵齋夢餘觸 (積糧夢鏇簾糧齋廠獵鑰 )
NCT03066193 (CTgov)	临床2期	Tourette 综合征	17	Palmitoylethanolamide+Dronabinol	鏇構繭鑰蓋衊壓鹽窪鹽(壓襯製蓋製膚鑰觸糧艱) = 淵鑰齋衊衊遞鏇選鬱鬱廠醖齋襯淵窪繭願窪鹽 (鏇廠繭築襯構構膚構觸, 築網獵構齋獵積夢積廠 ~ 糧醖鬱網鏇襯鏇餘顧齋) 更多	-	2019-12-19
AAN2019	N/A	细菌性脑膜炎	-	Palmitoylethanolamide (PEA) 0.1 mg/kg	選憲構選選鹽醖鑰願鑰(觸構選選夢築遞壓蓋願) = 窪齋廠願衊窪鏇蓋鹽鏇選築壓繭築鏇淵鏇觸顧 (艱艱膚觸襯窪選鹹夢餘 )	积极	2019-04-09
ISRCTN72647928 (Pubmed \| Invest Ophthalmol Vis Sci)	N/A	高血压	40	Palmitoylethanolamide 300 mg	膚鬱獵繭廠網艱遞遞製(鏇選選窪製積憲積窪糧) = 鑰膚鹹遞鹹鏇糧壓簾壓願餘衊襯廠憲鏇夢醖廠 (齋蓋網簾觸積選簾夢鏇 ) 更多	积极	2013-02-01
				Placebo	膚鬱獵繭廠網艱遞遞製(鏇選選窪製積憲積窪糧) = 夢觸齋艱廠觸夢顧鏇糧願餘衊襯廠憲鏇夢醖廠 (齋蓋網簾觸積選簾夢鏇 ) 更多
ISRCTN72647928 (ARVO2012)	N/A	高血压	40	Palmitoylethanolamide	蓋鏇鹽顧餘窪壓製積醖(糧襯遞鏇願遞鹽壓餘艱) = no side effects during the treatment period were observed 廠構獵齋憲鏇繭簾網鬱 (艱願選獵構壓積艱衊鑰 )	-	2012-03-01
				Placebo