A Phase I/II, Open-label Study to Evaluate the Abscopal Response and Safety of Manganese and Standard-of-care Radiotherapy/ SBRT in Subjects With Metastatic Solid Tumors or Lymphoma

Radiotherapy is a regular care for metastatic solid tumors or lymphoma, and it can induce immunogenic death of tumor cells and a stronger immune response. Sometimes, tumor regression would be observed at sites distant to an irradiated field because of the radiotherapy-induced anticancer immune responses, so-called abscopal response. Manganese has been confirmed to activate innate immune and function as anticancer immunoadjuvant in pre-clinical studies. This study is designed to assess the abscopal response and safety of combined therapy of manganese and radiotherapy in patients with metastatic solid tumors or lymphoma.

开始日期2021-05-06

申办/合作机构

中国人民解放军总医院

NCT03989336

/ Completed临床2期IIT

A Randomized, Single-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Relapsed/Refractory Ovarian Cancer

Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer death in women. Platinum chemotherapy has been widely adopted as a standard treatment for advanced ovarian cancer, the response rates in patients with relapsed/refractory ovarian cancer is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This two-arm, phase I/II study is designed to assess the safety and efficacy of combined therapy of anti-PD-1 antibody and chemotherapy with or without Manganese priming.

开始日期2020-12-23

申办/合作机构

中国人民解放军总医院

NCT04119843

/ Completed临床3期

A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients With Known or Suspected Focal Liver Lesions and Severe Renal Impairment

The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.

开始日期2020-02-19

申办/合作机构

Ascelia Pharma AB

100 项与氯化锰相关的临床结果

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100 项与氯化锰相关的转化医学

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100 项与氯化锰相关的专利（医药）

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2,215

项与氯化锰相关的文献（医药）

2025-10-01·JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY A-CHEMISTRY

Enhanced photocatalytic degradation of tetracycline by Mn,S co-doped TiO2 under visible-light irradiation

作者: Li, Cui ; Zhang, Weibin ; Lin, Shu ; Qi, Kezhen

To mitigate the accumulation of toxic materials in the environment, the development of efficient photocatalysts offers a sustainable approach to solar energy-assisted environmental remediation.TiO₂-based photocatalysts are particularly attractive due to their favorable optical and electronic properties, low cost, and non-toxicity.In this study, Mn,S co-doped TiO₂ materials with varying doping ratios were synthesized using the sol-gel method and characterized via XRD, XPS, UV-vis DRS, SEM, and BET.Mn,S co-doping effectively reduced the band gap of TiO₂, enhancing light absorption.Specifically, the optimized 5%Mn-3%S-TiO₂ exhibited the smallest band gap of 2.28 eV.When applied to the photocatalytic degradation of tetracycline hydrochloride (TC), it achieved a degradation rate of 67.03 % within 180 min, marking a 31.63 % improvement compared to undoped TiO₂.These results underscore the potential of Mn,S co-doping to enhance the photocatalytic performance of TiO₂, presenting a promising approach for environmental restoration through the efficient degradation of harmful pollutants.

2025-07-01·SEPARATION AND PURIFICATION TECHNOLOGY

Synergistically regulating energy band structure and forming quantum wells to enhance the photocatalytic activity of Bi2MoO6 for tetracycline removal

作者: Liu, Guorong ; Yang, Hua ; Dai, Yanyan ; Ma, Jinyuan ; Xian, Tao ; Sun, Xiaofeng

An in-depth understanding of the synergistic effect of multiple parameters on the separation of photocarriers is crucial for the development of efficient photocatalysts for environmental remediation.In this study, we introduced an intermediate energy level via Mn-doped Bi₂MoO₆ (Bi_2-xMn_xMoO₆) to optimize the separation and migration of photogenerated charge carriers, thereby enhancing the photocatalytic degradation of tetracycline (TC).On this basis, oxygen vacancies were induced on its surface by glyoxal at low temperatureThese oxygen vacancies, acted as quantum wells and efficiently captured, photogenerated electrons, thereby inhibiting the recombination of photogenerated carriers and improving the catalytic activity.The results indicated that under simulated light irradiation, the photocatalytic degradation rate of TC by the optimal Bi_1.92Mn_0.08MoO₆-2 (K_app = 0.03388 min^-1) was 5.41 times that of the original Bi₂MoO₆ (K_app = 0.00626 min^-1).The toxicity of the intermediates formed during the degradation process was evaluated, and the influence of different factors on TC degradation were clarified.Finally, the catalytic mechanism was thoroughly investigated by combining experiments and theory.

2025-06-01·SEPARATION AND PURIFICATION TECHNOLOGY

Regulation of electron delocalization on porous carbon/manganese-iron oxide for enhancing nonradical processes of sulfamethoxazole: Oxidation pathway and mechanism

作者: Wei, Hang ; Huang, Ling ; Sun, Ao-Xia ; Chen, Zhi-Liang ; Sun, Meng-Qiang ; Feng, Yong ; Zhong, Jie ; Ying, Guang-Guo

Transition metal oxide defect engineering can regulate the electronic properties of materials, thereby realizing nonradical reactions during catalytic processes.In this study, porous carbon/manganese-iron oxide (PC@MFO) composites with different Mn/Fe ratios were prepared via in-situ encapsulation strategy.PC@MFO exhibited superior catalytic degradation and stable recycling performance during peroxymonosulfate (PMS) activation to degrade sulfamethoxazole (SMX).After 10 min of reaction, >92% of SMX was rapidly degraded, with high selectivity, through oxidative SMX removal from a complex aqueous solutionThe kinetics of SMX degradation over different as-prepared samples were also investigated.A recycling study and regeneration treatment revealed no clear deactivation between the 1st and 6th cycles, suggesting that PC@MFO is a reusable heterogeneous catalyst for utilization in efficient oxidative SMX removal.Multiple characterization techniques and d. functional theory calculations were used to study the mechanism of SMX degradation process.Nonradical oxidation was found to be the dominant reaction in the catalytic reaction, leading to SMX degradationThis was possibly due to the highly conjugated electron delocalization induced by Mn-Fe in the O-octahedra close to the oxygen vacancies, promoting rapid charge transfer and interfacial reaction kinetics.This study expands the understanding for the activation mechanism driven by Mn-Fe spinel oxides in deep-water treatment.

项与氯化锰相关的新闻（医药）

2025-04-29

·Cytiva学堂

解码细胞培养基开放与优化方法，助力生物工艺发展！

哺乳动物细胞是生物制药领域中最常用的宿主细胞之一，广泛应用于重组蛋白和单克隆抗体的生产。在过去的60年中，哺乳动物细胞培养技术经历了从简单到复杂、从小规模到工业化的巨大演变。培养基，作为细胞生长的“营养基石”，其配方优化对于提升产品产量、提升产品质量稳定性以及控制生产成本具有决定性影响，是上游工艺开发中的核心环节。01哺乳动物细胞培养用培养基配方的历史演变早期细胞培养基依赖血清或组织提取物，这些成分虽能支持细胞生长，但其复杂化学性质和可变性带来了污染风险，且难以明确细胞生长所需的最小营养成分。上世纪60年代HAM F12和DMEM/F12等经典培养基的成功开发，标志着培养基配方从经验驱动向科学设计的转变。这些培养基逐渐取代血清，成为当时细胞培养的主流选择。进入21世纪无血清培养基在早期成就的基础上，通过精细化补料策略、过程控制、质量源于设计（Quality by Design）理念的引入，以及个性化培养基定制的趋势，推动了培养基配方的持续优化。研究人员致力于开发能够支持更高细胞密度、更强细胞活力和更高重组蛋白含量的培养基配方，以满足日益增长的生物制药需求。02细胞培养基的关键组分能源物质：葡萄糖是主要碳源，但高乳酸积累可能抑制细胞生长。替代碳源（如半乳糖、甘露糖）和优化谷氨酰胺代谢（如使用丙酮酸或谷氨酸）可改善代谢效率，减少副产物积累。氨基酸：必需氨基酸（如亮氨酸、色氨酸）和非必需氨基酸（如精氨酸、半胱氨酸）对细胞生长和产品质量具有显著影响，需精确调控其浓度以满足细胞代谢需求。脂质和维生素：脂质前体（如胆碱）和维生素（如B族维生素）对细胞膜结构和代谢至关重要。微量元素和无机盐：铜、锌等微量元素以及钠、钾、钙等离子在代谢调控和渗透压平衡中发挥关键作用，需精确配比以确保细胞生长环境的稳定性。03细胞培养基开发全流程细胞培养基的开发是一个系统化的过程，涵盖需求分析与设计、组分筛选优化以及工艺放大与验证三个阶段。1在需求分析与设计阶段需明确目标产物的特性（如抗体类型），确定关键质量属性（CQAs），并设计实验方案（DoE）以指导后续开发。2在组分筛选优化阶段研究人员基于培养基原型库，优化氨基酸、维生素和微量元素等关键组分，并根据代谢需求调整补料成分与浓度，确定补料的时机与频率，实现精准营养供给。3在工艺放大与验证阶段研究人员将培养工艺从摇瓶逐步转移到生物反应器，调整规模放大参数，并验证批次一致性和稳定性，确保工业生产的可靠性和一致性。图1：细胞培养基开发流程图04细胞培养基优化方向产量优化提高产量是培养基优化的核心目标。关键营养素浓度的平衡对细胞生长和抗体产量至关重要。例如，葡萄糖和谷氨酰胺的比例需要精确调控，以确保细胞获得足够的能量和碳源，同时避免代谢副产物的积累1。代谢副产物如乳酸和氨的积累会抑制细胞生长，降低抗体产量2。因此，优化培养基时需要通过实验设计和动态监测，控制这些副产物的生成。此外，能量代谢的调节也是提高产量的重要策略。通过补充三羧酸循环（TCA循环）中间物，如α-酮戊二酸和苹果酸，可以增强细胞的能量代谢，提高抗体产量3。质量属性调控抗体质量属性的优化同样至关重要。糖基化调控是影响抗体功能和稳定性的关键因素4。图2：N-糖糖型图谱4例如，调整锰离子浓度可以显著影响糖型分布, 在添加了锰离子的实验中，当环境中葡萄糖的浓度为30 mM时，高甘露糖型水平较低5，尿苷和半乳糖的补充可以改变末端糖结构6，这些调控措施可以显著提高抗体的稳定性和生物活性。此外，电荷异构体控制也是优化的重要方面。表一总结了酸碱峰形成的主要原因。通过明确酸碱峰形成原因，能够有的放矢地进行优化。表1：酸碱峰形成原因例如针对C端赖氨酸保留引起的碱峰，及时调整铜锌离子浓度比例可显著降低碱峰比例7，而培养温度和pH的精确控制可以减少脱酰胺水平8，从而提高抗体的均一性和稳定性。最后，聚集体与片段控制也是优化的重要内容。EDTA和半胱氨酸的添加可以减少蛋白质片段化9，而渗透压的调节可以降低蛋白质聚集10，提高抗体的稳定性。温度策略的优化也可以显著影响产物的稳定性，确保抗体在储存和运输过程中的质量。05细胞培养基优化方法系统生物学和机器学习方法的广泛应用，为培养基优化提供了强大的技术支持。系统生物学通过整合多组学数据（如基因组学、转录组学、代谢组学）和计算模型，深入理解细胞代谢网络。GEMs-基因组规模代谢模型通过整合细胞的代谢网络和蛋白分泌通路，预测关键代谢途径和营养需求。FBA-通量平衡分析通过计算代谢网络中的通量分布，优化培养基成分以提高目标产物的产量。动态代谢模型结合实验数据，模拟细胞在不同培养条件下的动态代谢行为。机器学习方法则通过分析大量实验数据，识别隐藏模式并预测最佳培养条件。监督学习可以预测培养基成分对细胞生长和抗体产量的影响，例如利用监督学习框架优化了CHO细胞培养基的金属离子例如铁和锌离子浓度，提高了抗体的电荷均一性11。非监督学习通过聚类分析发现培养基成分与细胞行为之间的隐藏关系，例如利用PCA分析指出过高的半胱氨酸水平会压倒细胞的抗氧化防御系统，最终阻碍细胞生长12。混合机器学习和系统生物学框架与基于模型的实验设计（DoE）相结合，显著提高了实验效率，减少了实验负担和复杂性。系统生物模型提供细胞过程的机制理解，机器学习算法擅长从复杂数据集中识别模式和进行预测，两者的协同作用加速了培养基优化进程。结语哺乳动物细胞培养基开发经历了从经验驱动到数据驱动的转型，系统生物学通过多组学整合和代谢网络建模揭示关键营养需求，机器学习则从海量数据中挖掘优化规律。两者结合的智能框架结合模型引导的实验设计，大幅提升了优化效率，同时降低了实验成本与复杂性。Cytiva中国细胞培养基开发基地依托HyClone品牌，针对本土企业对高效开发和精准适配的需求，提供商业化培养基和补料组合的定制服务。基地利用全球庞大的培养基原型库，根据客户需求筛选或优化培养基和补料配方，实现量身定制。同时，引入先进的培养基开发和实验设计理念，结合细胞代谢通路分析、DoE方法和检测设备，灵活制定方案，提供全方位服务支持，解决细胞生长缓慢、存活率低等问题，满足高质量品控需求。随着生物制药行业的不断发展，哺乳动物细胞培养基的开发和优化将继续朝着更加精准、高效和智能化的方向迈进。通过跨学科的协同创新，未来的研究将进一步突破现有技术瓶颈，为生物制药行业带来更优质、更经济的治疗产品，推动行业的持续进步和创新。如您对培养基优化有任何问题或需求请扫码留下您的信息，我们将有专人与您联系！参考文献1.Hong JK, Nargund S, Lakshmanan M, et al. Comparative phenotypic analysis of CHO clones and culture media for lactate shift. J Biotechnol. 2018;283:97-104. doi:10.1016/j.jbiotec.2018.07.0422.Pereira S, Kildegaard HF, Andersen MR. Impact of CHO Metabolism on Cell Growth and Protein Production: An Overview of Toxic and Inhibiting Metabolites and Nutrients. Biotechnol J. 2018;13(3):e1700499. doi:10.1002/biot.2017004993.Saldanha M, Padhye K, Warke VG, et al. A feed enrichment strategy targeting the tricarboxylic acid cycle for increasing monoclonal antibody production and alleviating ammonia accumulation in Chinese hamster ovary cell culture.Biochemical Engineering Journal, 2023; Volume 192, 108836. https://doi.org/10.1016/j.bej.2023.108836.4.Torkashvand F, Vaziri B. Main Quality Attributes of Monoclonal Antibodies and Effect of Cell Culture Components. Iran Biomed J. 2017;21(3):131-141. doi:10.18869/acadpub.ibj.21.3.1315.Surve T, Gadgil M. Manganese increases high mannose glycoform monoclonal antibody expressed in CHO when glucose is absent or limiting: Implications for use of alternate sugars. Biotechnol Prog. 2015;31(2):460–467.6.Gramer MJ, Eckblad JJ, Donahue R, et al. Modulation of antibody galactosylation through feeding of uridine, manganese chloride, and galactose. Biotechnol Bioeng. 2011;108(7):1591-1602. doi:10.1002/bit.230757.Luo J, Zhang J, Ren D, et al. Probing of C-terminal lysine variation in a recombinant monoclonal antibody production using Chinese hamster ovary cells with chemically defined media. Biotechnol Bioeng. 2012;109(9):2306-2315. doi:10.1002/bit.245108.Chung S, Tian J, Tan Z, et al. Industrial bioprocessing perspectives on managing therapeutic protein charge variant profiles. Biotechnol Bioeng. 2018;115(7):1646-1665. doi:10.1002/bit.265879.Trexler-Schmidt M, Sargis S, Chiu J, et al. Identification and prevention of antibody disulfide bond reduction during cell culture manufacturing. Biotechnol Bioeng. 2010;106(3):452-461. doi:10.1002/bit.2269910.Paul AJ, Handrick R, Ebert S, Hesse F. Identification of process conditions influencing protein aggregation in Chinese hamster ovary cell culture. Biotechnol Bioeng. 2018;115(5):1173-1185. doi:10.1002/bit.2653411.Gangwar N, Balraj K, Rathore AS. Explainable AI for CHO cell culture media optimization and prediction of critical quality attribute. Appl Microbiol Biotechnol. 2024;108(1):308. Published 2024 Apr 24. doi:10.1007/s00253-024-13147-w12.Komuczki D, Stadermann A, Bentele M, et al. High cysteine concentrations in cell culture media lead to oxidative stress and reduced bioprocess performance of recombinant CHO cells. Biotechnol J. 2022;17(11):e2200029. doi:10.1002/biot.202200029本期关键词：#HyClone

细胞疗法

2024-12-23

·access wire

Ascelia Pharma Patent Granted in China for Second Generation Orviglance

MALMÖ, SWEDEN / ACCESSWIRE / December 23, 2024 / Ascelia Pharma (STO:ACE) Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the Chinese patent authorities have granted patent protection for the second-generation Orviglance®The new patent covers the effervescent tablet formulation of Orviglance. This formulation makes it even easier for patients and health care professionals to use the product. This patent protection until 2040 in China further strengthens the value proposition of the Orviglance franchise.ContactsMagnus Corfitzen, CEOEmail: [email protected]Tel: +46 735 179 118Julie Waras Brogren, Deputy CEO (Finance, Investor Relations & Commercial)Email: [email protected]Tel: +46 735 179 116This information was submitted for publication, through the agency of the contact persons set out above.About usAscelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates - Orviglance and Oncoral - in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit http://www.ascelia.com.About OrviglanceOrviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A clinical program of nine studies, including the pivotal global Phase 3 study SPARKLE, has successfully been completed with strong and consistent efficacy and safety results.AttachmentsAscelia Pharma Patent Granted in China for Second Generation OrviglanceSOURCE: Ascelia PharmaRelated Documents:

临床3期孤儿药

2024-12-17

·access wire

Ascelia Pharma Announces Acceptance of SPARKLE Phase 3 Data for Presentation at the Society of Abdominal Radiology Congress 2025

MALMO, SWEDEN / ACCESSWIRE / December 17, 2024 / Ascelia Pharma (STO:ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that two scientific abstracts with clinical data from the SPARKLE Phase 3 study with Orviglance have been accepted as an oral presentation and a scientific poster at the Society of Abdominal Radiology Congress, taking place from 16-21 February 2025 in Tucson, AZ, US.The two abstracts highlight the positive outcomes of the SPARKLE Phase 3 study. In the study Orviglance was shown to enhance the detection of suspected or known liver lesions, including small-sized lesions, and consistently shows positive results in visualizing lesions in both patients with hepatocellular carcinoma (HCC, primary liver cancer) and those with liver metastases. The study includes patients with severe renal impairment who currently lack an alternative to gadolinium-based contrast MRI.The abstract "Improved detection of focal liver lesions with manganese-based contrast agent in patients with severe kidney impairment: evidence from the SPARKLE study" was accepted as an oral presentation and "Hepatocellular carcinoma (HCC) and hepatic metastases: visualization with manganese-based contrast agent enhanced liver MRI in patients with severe kidney disease, evidence from the SPARKLE study" is to be presented in the abstracts section."The acceptance of these abstracts by the Society of Abdominal Radiology Congress is a key achievement. This prestigious event is renowned for being an important gathering for experts and professionals in the field of abdominal radiology, offering unparalleled opportunities for learning, networking, and showcasing groundbreaking research" says Andreas Norlin, CSO Ascelia Pharma.The oral presentation abstract will be held on Sunday February 16, 2025, from 10:43 AM and will be part of the Clinical Practice Improvement session.ContactsMagnus Corfitzen, CEOEmail: [email protected]Tel: +46 735 179 118Julie Waras Brogren, Deputy CEO (Finance, Investor Relations & Commercial)Email: [email protected]Tel: +46 735 179 116This information was submitted for publication, through the agency of the contact persons set out above.About usAscelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates - Orviglance and Oncoral - in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit http://www.ascelia.com.About OrviglanceOrviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A clinical program of nine studies, including the pivotal global Phase 3 study SPARKLE, has successfully been completed with strong and consistent efficacy and safety results.AttachmentsAscelia Pharma Announces Acceptance of SPARKLE Phase 3 Data for Presentation at the Society of Abdominal Radiology Congress 2025SOURCE: Ascelia Pharma

临床3期孤儿药

100 项与氯化锰相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04852	-	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
造影剂	日本	Meiji Seika Pharma Co., Ltd.	2006-04-20
营养紊乱	美国	Hospira, Inc.	1986-06-26

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适应症	最高研发状态	国家/地区	公司	日期
脑转移瘤	临床2期	中国	中国人民解放军总医院	2021-05-06
淋巴瘤	临床2期	中国	中国人民解放军总医院	2021-05-06
转移性实体瘤	临床2期	中国	中国人民解放军总医院	2021-05-06
复发性卵巢癌	临床2期	中国	中国人民解放军总医院	2020-12-23
晚期胆道癌	临床2期	中国	中国人民解放军总医院	2019-03-01
转移性胰腺癌	临床2期	中国	中国人民解放军总医院	2019-03-01
胆管癌	临床1期	中国	中国人民解放军总医院	2018-11-01

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适应症

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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


NCT03989336 (ASCO 12020 \| ASCO 22020) 人工标引	临床2期	卵巢癌末线	27	nab-paclitaxel+ cisplatin+MnCl2+Sintilimab	衊衊鏇繭獵廠願構顧簾(壓鹹蓋構鬱簾觸餘蓋壓) = The most common AEs are hematological toxicity (87%), nausea (56%) and vomiting (47%) in both two cohorts. 壓觸觸觸齋積鑰夢鏇膚 (醖艱遞範製選糧襯獵蓋 )	积极	2020-05-25
				cisplatin+nab-paclitaxel+Sintilimab