In this feasibility study, we aim to explore therapeutic Rheopheresis (RheoP) as a novel treatment option for SSc-associated Raynaud's phenomenon and/or digital ulcers and compare it to the standard of care treatment (intravenous iloprost. RheoP has been used for RP/DU with some success in observational studies, nevertheless, the optimal treatment modality, duration, or frequency of RheoP (and PEX in general) in SSc has not been established as of yet.

开始日期2022-02-28

申办/合作机构

University of Gottingen

[+1]

NCT04871035

/ RecruitingN/AIIT

Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)

This is an observations study evaluating safety and efficacy of immunoadsorption compared to plasma exchange in Guillain-Barré Syndrome.

开始日期2021-04-28

申办/合作机构

Universität Ulm

[+1]

NCT03969966

/ Unknown statusN/AIIT

Citrate Anticoagulation for Postdilution Hemofiltration

This study evaluates a protocol for regional citrate anticoagulation in critically ill patients with acute kidney injury who are treated with continuous veno-venous haemofiltration in postdilution mode.

开始日期2019-01-14

申办/合作机构

Heinrich-Heine-Universität Düsseldorf

[+1]

100 项与 Bio-Rad Laboratories, Inc. 相关的临床结果

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0 项与 Bio-Rad Laboratories, Inc. 相关的专利（医药）

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171

项与 Bio-Rad Laboratories, Inc. 相关的文献（医药）

2026-04-01·JOURNAL OF CLINICAL VIROLOGY

Characterization of HIV humoral immunity during analytical treatment interruption

Article

作者: Smith, Davey M ; Norris, Philip J ; Deeks, Steven ; Gandhi, Rajesh T ; Noutsios, George ; Di Germanio, Clara ; Bosch, Ronald J ; Balasko, Brendan G ; Villaflor, Patricia G ; Li, Jonathan Z ; Busch, Michael P

INTRODUCTION:

This study investigated whether HIV binding antibody (Ab) and p24 antigen (Ag) quantitation could detect humoral immune responses or p24 Ag before or following detectable plasma viral load (VL) rebound during antiretroviral therapy interruption (ATI) and provide insights into post-rebound viral replication.

METHODS:

Longitudinal plasma samples collected before and following ATI from 40 participants (485 samples; mean of 12/participant) in the ACTG A5345 study who began antiretroviral therapy during either acute or chronic stages of infection were analyzed using commercial immunoassays to assess HIV Ab and Ag dynamics, including following dissociation of immune complexes for improved Ag detection.

RESULTS:

Neither Ab nor Ag levels increased in plasma before VL rebound. However, 75% of participants exhibited increased Ab reactivity concurrent with or shortly after VL rebound, which declined upon ART reinitiation. Participants who were ART-treated early had lower Ab levels at ATI initiation but demonstrated greater fold increases in Ab during ATI than late-treated participants. Two participants who demonstrated post-treatment control of VL showed gradual Ab increases that paralleled intermittent VL elevations. p24 Ag was only detectable after dissociating immune complexes in samples with VL > 10⁴ RNA copies/mL, correlating strongly with VL levels.

CONCLUSIONS:

Although antibody levels did not predict viral rebound, tracking their longitudinal changes provided meaningful information about viral replication patterns and immune reactivation during and after rebound, offering a practical tool for monitoring ATI outcomes.

2026-01-01·JCO Precision Oncology

Generic Protocols for Analytical Validation of Tumor-Informed Circulating Tumor DNA Assays for Molecular Residual Disease: The Blood Profiling Atlas in Cancer's Molecular Residual Disease Analytical Validation Working Group Consensus Recommendation

Article

作者: Baden, Jonathan ; Dickey, Jennifer ; Karlin-Neumann, George ; Zhang, Shile ; Bisselou, Karl ; Lee, Jerry S.H. ; Danek, Tyler ; Liu, Li ; Sausen, Mark ; Leiman, Lauren C. ; Saritas-Yildirim, Banu ; Connolly Rohrbach, Jaime E. ; Pena, Carol E. ; Merriam, David ; Beer, Jonathan ; Palomares, Melanie ; Jones, Gregory ; Larson, Jessica L. ; Lopez Ramos, Dorys ; Rhodes, Kate ; Johann, Donald J. ; Anfora, Andrew T. ; Rathbun, Jessica ; Godsey, James H. ; Lin, Cheng-Ho Jimmy ; Corner, Adam S. ; Bungo, Jennifer

The presence of circulating tumor DNA (ctDNA) in patients indicates post-treatment molecular residual disease (MRD). Given the complexity of ctDNA-based MRD detection tests, consensus on analytical validation (AV) criteria is needed. To address this, the Blood Profiling Atlas in Cancer (BLOODPAC) Consortium's MRD AV Working Group evaluated existing protocols to develop standardized guidance for tumor-informed assays. Protocols pertaining to blood collection tube types, quantitative output, tissue processing, tumor or matched normal sequencing, software, and clinical validation were considered out of scope. After alignment on objectives and assumptions, study designs on the basis of best practices in the field, available assay validation guidance documents, and unique performance challenges for tumor-informed MRD assays were authored. Each protocol contains introduction, experimental design, statistical analysis, and an example data presentation per the US Food and Drug Administration (FDA) Center for Devices and Radiological Health standard format. Biostatisticians were consulted to define minimal test requirements, sample size, and appropriate statistical analyses. The protocols were submitted to the FDA via the presubmission process for formal written feedback followed by a meeting. BLOODPAC's generic protocols for the AV of tumor-informed ctDNA assays for MRD are designed to provide test developers with a core baseline of standardized AV protocols such that methods described can be adapted and applied for any tumor-informed MRD assay irrespective of technology, panel design algorithm, or workflow component. These protocols aim to optimize test developers' presubmission reviews with the FDA, ensuring productive meetings while enabling reviewers to streamline feedback. As always, test developers are encouraged to communicate with FDA directly around their particular AV methods.

2025-12-31·mAbs

Pioneer: a synthetic human antibody phage display library for rapid therapeutic lead generation

Article

作者: Ylera, Francisco ; Knappik, Achim ; Putyrski, Mateusz ; Hanuschka, Hanh ; Klee, Martina ; Wich, Melissa ; Hentrich, Christian ; Cavada, Manuel ; Werkmeister, Christina ; Preis, Waldemar ; Eick-Werner, Michaela ; Kellmann, Sarah-Jane ; Hanselka, Sarah

Antibody phage display, a biotechnological method for selecting fully human antibodies from diverse libraries, is firmly established in antibody drug discovery due to its speed and flexibility. In this study, we introduce Pioneer, one of the largest synthetic human antibody libraries developed to date, with approximately 2.2 × 10¹¹ functional members. Pioneer utilizes SpyDisplay, a phage display selection system that relies on SpyTag-SpyCatcher protein ligation technology and enables rapid selection of high-affinity antibodies. The library's antibodies are designed for favorable biophysical properties and developability and they can be rapidly labeled or converted into various formats for screening and functional assays. We validated the performance of Pioneer in a series of selection campaigns against diverse antigens. For antibodies against four targets, TIGIT, IL-6RA, C5aR and CXCR4, we performed in-depth functional and developability characterization. For all four targets, including the two challenging G-protein coupled receptors, we demonstrated that antibodies with parameters comparable to late-stage clinical candidates can be selected directly from the library. Our results highlight the effectiveness of the Pioneer library combined with SpyDisplay in generating therapeutic lead candidates with excellent affinity, specificity, and developability, offering a robust platform for rapid antibody discovery and development.

540

项与 Bio-Rad Laboratories, Inc. 相关的新闻（医药）

2026-05-08

·高创汇生物医药产业化平台

动物模型 | 模拟航天失重应激对小鼠学习记忆的影响及机制研究

随着中国航天事业的不断发展,中国已稳步进入中长期载人航天阶段。在这种背景下,长期居住在空间站的宇航员不断暴露在特定的航空航天环境中,其特点是微重力和密闭空间(机动性有限)等因素。这种暴露很容易导致一系列航天医学问题,包括认知能力下降、情绪变化、免疫功能减弱等。目前世界各国已开展真实航天和地面模拟微重力环境影响脑认知功能及其潜在机制的研究,并取得了一定的成果。航天医学研究也表明,在微重力飞行过程中,航天员的认知和学习记忆功能受到不同程度的影响。认知功能是大脑重要的高级功能之一。宇航员在轨道任务中准确高效地执行复杂操作的能力与其认知功能的状态密切相关。深入研究航天特因环境,尤其是失重环境对学习记忆的影响及其分子机制,对于保障航天员健康和提高任务成功率具有重要意义。由于人体模型受到有创实验的限制及相关伦理学的制约,在地面建立航天模拟环境进行相关的科学研究显得尤其重要。大鼠和小鼠的后肢卸载(hindlimb unloading,HU)模型被广泛用作模拟微重力条件的经典实验方法,其基本机制为动物尾吊后体液向头分布来模拟太空失重环境下宇航员的失重效应。研究发现,在模拟失重条件下, 动物的认知功能下降。例如, ZHANG等研究了不同持续时间的尾部悬吊对大鼠认知功能的影响,并观察到当尾部悬吊持续超过14d 时,大鼠的学习和记忆能力显著受损。随着尾吊时间的增加,这种认知缺陷逐渐恶化。 LV等发现,虽然模拟失重不影响动物的学习能力,但会影响维持学习的反射和识别信号能力。此外,ZHANG 等还发现,尾部悬吊模拟失重28d 后,水迷宫试验中的潜伏期和总游程显著增加,表明模拟失重损害了大鼠的空间学习和记忆能力,这和 WANG 等发现一致,该机制可能与谷氨酸兴奋毒性和特定神经递质失衡有关。然而,关于航天诱导的失重影响学习和记忆机制的研究仍然有限,特别是关于各种病理生理过程的作用,如氧化应激、炎症反应、细胞凋亡和线粒体功能障碍,这需要进一步探索。因此,本研究建立了 28dHU模型———尾部悬吊模拟航天失重。该研究通过整合各种行为测试和分子生物学技术,旨在系统阐明失重对小鼠学习记忆能力的影响,揭示其潜在的分子机制,从而为预防航天员认知功能障碍提供理论依据。 1 材料和方法 1. 1 实验动物 5~6 周龄 SPF级雄性 ICR小鼠48只,体质量25~27g,购自北京维通利华实验动物有限公司。本研究中的所有实验动物均饲养于中国医学科学院药用植物研究所[SYXK(京)2023-0008],自由饮食,光照周期为12h 明暗交替,室温(23±2)℃ ,湿度(55±10)%。实验前适应环境 5d。实验过程遵循 3R 原则,并经过中国医学科学院药用植物研究所实验伦理委员会审批(SLXD-20240409021)。 1. 2 主要试剂与仪器丙二醛(malondialdehyde,MDA)测定试剂盒(货号 A003-1)购自南京建成生物工程研究所;过氧化氢(hydrogen peroxide,H2O2 )测定试剂盒(货号 A064-1) 购自南京建成生物工程研究所;BeyoECL Moon 试剂盒(货号 P0018FM)、BeyoECLPlus 试剂盒(货号 P0018M)均购自上海碧云天生物技术股份有限公司;B 细胞淋巴瘤 2 ( B-celllymphoma 2, Bcl2,货号 Ab194583)、Bcl2 关联 X蛋白 ( Bcl2-associated X protein, Bax, 货号Ab32503)、沉默信息调节因子 1(silent informationregulator 1,SirT1,货号 Ab189494)、哺乳动物雷帕霉素靶蛋白 ( mammalian target of rapamycin,mTOR, 货号 Ab2732 )、线粒体转录因子 A(mitochondrial transcription factor A,mtTFA,货号Ab252432) 均购自英国 Abcam 公司;SirT3(货号5490S)、转录因子核因子红系 2 相关因子 2( nuclear factor E2 related factor2, Nrf2, 货号12721)、血红素氧合酶 1(hemeoxygenase-1,HO-1,货号 43966)、半胱天冬酶 1 ( cysteinyl aspartatespecific proteinase 1, Caspase-1, 货号 24232S )、Caspase-3(货号 96645)、Caspase-8(货号 8592),均购自美国 Cell Signaling Technology 公司;伤湿止痛膏(国药准字 Z20023035)购自河南羚锐制药股份有限公司。模拟失重尾部悬吊实时检测装置(中国发明专利号:ZL 201310228949. 2)、小鼠物体认知测试箱、小鼠水迷宫实时检测分析处理系统、穿梭五合一分析系统 ( 中国发明专利号: ZL200710004992. 5),均由中国医学科学院药用植物研究所和中国航天员科研训练中心联合研发;超声破碎仪(型号:Vobra Cell),美国索尼克公司;高速低温离心机(型号:Fresco21),美国赛默飞世尔科技有限公司; 电泳仪 ( 型号: Mini-PRPTEANTetra),美国 Bio-Rad 公司;接触式化学发光成像仪(型号:eBlot Touch Imager),易孛特生命科学有限公司;脱色摇床(型号:TS-1000),海门市其林贝尔仪器制造有限公司;酶标仪( 型号:MultiskanFC),美国赛默飞世尔科技有限公司;ANY-maze动物行为分析系统,美国 Stoeling 公司。 1. 3 实验方法 1.3.1动物分组第一批:动物适应环境 5d 后,将其随机分为对照组和模型组,每组 12只。对照组,不进行尾吊应激;模型组,尾部悬吊应激处理,造模 28d 后进行 Y 迷宫、水迷宫、跳台的行为学检测,造模持续到行为学检测结束。实验流程见图 1A。第二批:动物适应环境 5d 后,将其随机分为对照组和模型组,每组 12只。对照组,不进行尾吊应激;模型组,尾部悬吊应激处理,造模 28d 后进行新物体识别、穿梭的行为学检测,造模持续到行为学检测结束。实验流程见图1B。 1.3.2样本处理行为学测试结束后,将小鼠取血并立即脱颈处置后于冰上分离海马组织,采集的血液在 4 ℃过夜凝固。随后, 将凝固的血液在 4 ℃ 下以1 500 r/ min 离心 15 min,以获得血清。血清和海马组织样本均于-80 ℃ 保存,直至提取用于进一步检测 ( 第一批对照组与模型组的海马用于Nrf2 / HO-1 通路、线粒体相关蛋白的检测;第二批对照组与模型组的海马用于炎症、凋亡相关蛋白的检测)。 1. 3. 3 HU 模型的建立尾部悬吊 30°是模拟航天失重效应的经典动物实验方法,最早在 1979 年由 MOREY建立。实验过程中,先将一块伤湿止痛膏(7cm×1cm)紧紧贴在小鼠尾部约 1cm 处,用折叠和包裹的方法固定。然后在外部用医用胶带(0.9cm×5cm)加固。在操作过程中,施加适度的压力,并根据小鼠的反应及时调整松紧度。对于悬挂,固定尾巴的折叠部分挂在定制的尾巴悬挂钩上,确保小鼠的前肢在后肢悬挂时保持接地,保持其身体和笼底之间的 30°角。悬尾钩需精心调整角度,确保小鼠活动时不会脱落。实验期间小鼠可自由活动和进食饮水,对照组则正常饲养。该模型能有效模拟失重状态对生理系统的影响,实验周期通常持续 4 周。 1.3.4 Y 迷宫在进行 Y 迷宫实验前,动物会被放入测试室进行适应。实验开始时,将小鼠置于连接 3 个臂的中央区域,并允许其在迷宫中自由探索 8min。在此过程中,使用摄像头追踪并记录小鼠的探索路径。然后使用 ANY-maze 5.14 软件计算自发交替的百分比,自发交替被定义为以正确顺序进入3个不同臂的行为, 即 ABC、 ACB、 BCA、 BAC、CAB、CBA,计算公式为:自发交替百分比/ % = 自发交替数/ (进入臂的总数-2)×100%。 1.3.5新物体识别实验为了适应环境,这些小鼠被提前放在实验室里。在适应期,将动物置于没有任何物体的实验箱中,每只小鼠停留10min,进行 1d 的适应期。新的物体识别实验在 24h 后进行。首先,进行熟悉阶段测试。测试时,将小鼠依次放入装有两个相同物体的实验箱中,记录每只动物在 5min 内对左右物体的探索时间。 30min 后进行检测期测试,将箱子里的其中一个物体更换为新物体。动物放入后计时 5 min,分别记录动物在不同时间段对熟悉物体的探索时间和对新奇物体的探索时间。相对辨别指数 RI = ( Tn-Tf) / ( Tn+Tf),“ Tn”表示测试期时动物对新奇物体的探索时间,“Tf”表示测试期时动物对熟悉物体的探索时间。 1.3.6 Morris 水迷宫 Morris 水迷宫是利用小鼠会游泳又怕水的天性,强迫其在水中游泳。实验分为两部分:(1)定位航行实验:为期 5d。小鼠先在实验环境适应1h,给药30min后开始检测,水温维持在( 20±2)℃ 。圆柱形平台固定在某一象限内,隐藏于水下 1~1.5cm处。记录90s内找到平台的时间(潜伏期),90s 内未找平台的小鼠,需要将小鼠引导到平台上停留10s,每天每只小鼠进行2次测试,以此评估学习能力。并辅以目标象限游程比和时间比分析。 (2) 空间探索实验:在定位航行实验结束 24h 后进行,撤去平台,从平台的对角象限将小鼠放入水中,记录 90s 内的总游泳距离、平均速度及穿越原平台位置的次数和速度,每只动物测试 1 次,用于评价小鼠的记忆保持能力。 1.3.7 跳台实验共经过两天,第 1 天进行获得阶段,第 2 天进行巩固阶段。(1)获得阶段跳台实验中,将明暗箱间的小门用挡板封闭,并在原门处放置一个直径和高均为 5cm 的黑色绝缘平台 ( 安全区)。当动物接受电刺激(0.3mA)时,它们会寻找一个安全的区域来避免刺激,并在多次训练后学会记住位置。在实验过程中,首先将动物面向箱门放置,让其适应环境3min,然后进行5min 的电刺激,记录5min内错误次数(跳下平台次数)、潜伏期(第1次跳上平台所需的时间)等指标以评估学习记忆能力。(2)巩固阶段跳台获得阶段后第2天进行,每只动物与第1天的检测间隔24h。参数设置同前。将动物置于安全跳台上后立即开始实验,动物跳下安全平台遭受电击。 1.3.8穿梭实验在穿梭实验中,动物接收特定的信号(如光或声音刺激)。如果不立即做出反应,他们将受到电击(1.5mA)。为了避免电击,动物必须逃到对面的安全区域(被动回避)。经过 5d 的连续训练,动物学会了将信号与电击联系起来,形成主动回避反应(条件反射),这体现了高级联想记忆能力。实验选择系统中的“随机延迟模式”,信号刺激和电刺激延迟时间均为3~8s,电刺激持续 3~8s,总时长15min。正式检测前,动物需在箱内自由适应3min。若动物仅在灯光刺激时穿梭(避免电击),记为回避反应;若在灯光和电击同时存在时穿梭,则记为逃避反应。通过记录这两种反应,可评估动物的学习记忆能力。 1.3.9 生化试剂盒检测 MDA、H2O2 生化指标均使用血清进行 ELISA试剂盒检测,检测方法均按照试剂盒说明书进行。 1.3.10 Western blot 法检测海马组织中蛋白的表达海马组织匀浆后于冰上静置30min,4 ℃12000r/min,将样品离心30min,收集上清液。使用 BCA 方法测量蛋白质浓度。取适量蛋白质上清液, 与蛋白质裂解缓冲液和 SDS-PAGELoading Buffer(5×)混合,配制成浓度为 4μg/μL的蛋白质溶液,将溶液煮沸,等分,储存于-80℃ ,使用含 8%~10%聚丙烯酰胺凝胶的 SDS-PAGE系统进行蛋白质分离。随后, 在冰水浴中以100V 的恒定电压将蛋白质转移到 NC 膜上。根据目标蛋白质的分子量调整转移时间。蛋白膜使用 5%脱脂牛奶室温封闭后洗脱,用 TBST 洗涤 3次后 ,与稀释的一抗孵育(Bax,1∶1000;Bcl2,1∶1000;SirT1,1∶1000;SirT3,1∶1000;Nrf2,1∶2 500;mTOR,1∶2000;mtTFA,1∶1000;P-mTOR,1∶1000;HO-1,1∶1000;Caspase-1,1∶1 000; Caspase-3,1∶1000;Caspase-8,1∶1000),在 4℃下过夜。并使用 HRP标记的二抗在室温下孵育 1.5h。用 TBST洗涤3次后,在室温下与二抗孵育1h。通过 BeyoECL Plus/ Moon试剂盒显现蛋白条带,使用 ImageJ 1. 6. 0 软件分析条带密度的灰度值。 1. 4 统计学方法实验结果采用 SPSS 26. 0 软件进行分析。所有数据均采用平均数±标准误差( x􀭰±sx􀭰)表示。两组间数据比较采用独立样本 t 检验,P<0. 05 被认为有显著性差异。同一批次动物每组起始样本量为 12只。在实验过程中,对出现与技术问题(如视频追踪失败)或与实验处理无关的健康问题的动物个体进行了排除,同时在统计学分析中也采用 Spss 箱盒图鉴别异常值。因此,不同行为学测试中的最终有效样本量(N 值)略有不同,所有统计分析均基于这些有效的最终样本量进行。分析结果采用 GraphPad Prism 8. 0 软件绘制图表。 2 结果 2. 1 Y 迷宫实验对 Y 迷宫的影响,如图 2 所示,与对照组相比,模型组小鼠自发交替百分率并未降低,无显著性差异(P>0. 05)。提示经历模拟失重诱导的小鼠工作记忆能力可能并未受到影响。 2. 2 Morris 水迷宫实验如图 3 所示,与对照组相比,模型组小鼠的游泳轨迹更加复杂,说明模型组小鼠在水迷宫实验中表现出更强的探索欲。在水迷宫定位航行阶段,与对照组相比,模型组小鼠的寻台潜伏期在第4 天和第 5 天明显增加(P<0. 05),第 2 天显著增加(P<0. 01),说明模型组小鼠表现出较差的记忆能力;与对照组相比,模型组小鼠的目标象限游程比降低,但无显著性差异(P>0. 05);与对照组相比,模型组小鼠的目标象限时间比在第 2 天明显降低(P<0. 05),第 4 天显著降低(P<0. 01),第 5天极显著降低(P<0. 001),说明模型组小鼠工作记忆能力下降。在水迷宫空间探索阶段,与对照组相比,模型组小鼠的穿台次数、目标象限游程比、目标象限时间比均降低,但均未出现显著性(P>0. 05)。 2. 3 跳台实验如图 4 所示,在跳台实验中,与对照组相比,模型组小鼠潜伏期在获得阶段显著上升 ( P <0.01),在巩固阶段明显下降(P<0. 01);模型组小鼠的安全区时间在获得阶段及巩固阶段均极显著下降(P<0.001)。 2. 4 新物体识别实验如图 5 所示,与对照组相比,模型组小鼠辨别指数明显降低(P<0.05)。且模型组小鼠辨别指数为负值,表明其无法辨别出新物体和原熟悉物体,物体识别能力下降。 2. 5 穿梭实验如图 6 所示,随着训练天数增加,与对照组相比,模型组小鼠在穿梭实验中的成绩均有所提升,表现为模型组小鼠主动穿梭次数在第 2~4天显著少于对照组(P<0.01,P<0.001,P<0.05),逃避次数在第 1~4 天显著多于对照组(P<0.01,P<0. 05,P<0. 01,P<0.01),安全区时间在第1~4天显著缩短(P<0.05,P<0.05,P<0. 001,P<0.01)。说明模型组小鼠的联想学习记忆能力减退。 2. 6 模拟失重对小鼠血清中氧化应激水平的影响如图 7 所示,模型组小鼠显著诱导了氧化应激,可通过改变小鼠血清中的氧化应激含量证明。通过检测脑组织中 H2O2 水平发现,与对照组比较,模型组含量明显升高( P< 0.05)。同时对于MDA 的检测结果观察到相同趋势,模型组氧化应激反应增加(P<0. 05)。 2.7 模拟失重对小鼠海马组织中蛋白水平的影响 2.7.1 模拟失重对 Nrf2 / HO-1 通路的影响如图 8 所示,与对照组相比,模型组小鼠海马组织中 Nrf2 蛋白相对表达量显著降低(P<0. 001),HO-1 蛋白相对表达量明显降低(P<0. 05)。 2.7.2 模拟失重对海马线粒体相关蛋白表达的影响如图 9 所示,与对照组相比,模型组 mtTFA、P-mTOR/ mTOR、SirT1、SirT3 蛋白相对表达量显著降低(P<0. 001,P<0. 05,P<0. 001,P<0. 01)。 2.7.3 模拟失重对海马炎症相关蛋白水平的影响如图 10 所示, 与对照组相比, 模型组中IL-33、COX-2 蛋白的相对表达量显著增加( P <0. 05,P<0. 01)。 2.7.4模拟失重对海马凋亡蛋白表达的影响如图 11 所示, 与对照组相比, 模型组中Caspase-3、Caspase-8 蛋白的相对表达量显著增加(P<0. 01),Bcl2 蛋白的相对表达量显著降低(P<0. 01),导致 Bcl2 / Bax 平衡被破坏(P<0. 001)。 3 讨论由于技术进步和项目资金的实际限制,在短期内完成长期、高频率的空间任务具有挑战性。因此,建立有效的地面模拟失重实验方法体系对于相关的生理和医学研究具有重要的理论和实用价值。在动物实验中,通常使用HU和头低位倾斜的组合来模拟失重条件下血液向头部再分布的生理效应。 HU作为模拟微重力的地面动物模型,已经被学术界广泛接受和认可。 30°尾部悬吊诱导的 HU 常被用作模拟失重的经典建模方法,已被证明会导致啮齿类动物学习记忆能力下降。在这些方法中,30°尾部悬吊模型被认为是模拟失重条件的首选方法。它的特点是压力温和、持续时间可调、前肢正常承重,在保留颈椎的同时卸载腰椎, 并诱导头端液体的重新分布。 COSMOS 2044 国际空间任务将 HU 模型设为与飞行啮齿动物同步的对照,结果显示,HU大鼠肌球蛋白周转减缓,并诱发体液重分布、骨质疏松及循环系统失调等综合征,与航天员在真实微重力环境下经历的生理变化是高度一致的。所以本研究选用小鼠尾部悬吊 30°来模拟航天失重模型研究。新物体识别实验是基于啮齿动物天生具有的新奇偏爱性,动物分别根据“新旧物体”特征辨别,用于检测物体识别记忆。本研究中,模拟失重小鼠在新物体识别实验中的辨别指数显著降低,表明其辨别能力受损;Morris 水迷宫最早由MORRIS在 1981 年提出,是一种经典的动物学习记忆行为学检测方法,通过观察动物利用空间定位寻找逃生平台的能力,来评估其空间记忆与学习功能。在 Morris 水迷宫测试中,模型组的小鼠表现出寻台潜伏期延长,目标象限游程比和目标象限时间比下降,表明空间记忆受损。这些结果与 WU 等的报告一致。穿梭试验和Morris 水迷宫试验都是认知行为评估方法,利用惩罚情境(水环境和电击) 迫使小鼠学习回避行为。穿梭测试通过要求动物使用光信号(条件刺激)作为主动避免电击(非条件刺激)的线索来评估联想学习和记忆。在本研究进行的穿梭试验中,模型组表现出主动穿梭次数减少,逃避失败次数增加,表明其联想学习和记忆下降,与 FENG等的研究结果一致;跳台实验是被动性条件反射行为检测方法,主要测试动物对空间位置辨识的学习记忆能力。这项研究分两个阶段评估了学习和记忆的获得和巩固。在跳台测试的结果中,模型组小鼠在获得阶段的逃避潜伏期显著缩短,而在巩固阶段潜伏期显著延长。同时,在安全区的时间也大大减少。这些发现表明,模型组小鼠的记忆巩固能力明显受损,与吴大蔚等结果一致,进一步证明尾部悬吊可引起动物学习记忆能力的下降,也证实了航天失重环境对认知功能的负面影响。综上,模拟航天失重应激 4 周可导致小鼠学习记忆能力显著下降,包括造成情景记忆、短期/ 长期记忆、空间/ 非空间记忆、联想/ 非联系学习的损伤。正常情况下机体内的氧化-抗氧化水平保持平衡, 低、中浓度的活性氧 ( reactive oxygenspecies, ROS)参与免疫反应、炎症、学习和记忆等过程,线粒体是 ROS 诱导损伤的主要目标。在外源刺激下,ROS 生成和机体抗氧化防御能力之间的动态平衡被破坏,随后导致氧化应激。H2O2 是重要的信号调控因子,而高浓度的H2O2 则会导致细胞毒性作用。 MDA 作为脂质过氧化的生物标志物,可以精确量化体内脂质过氧化的强度。研究证实,模拟失重显著增加氧化应激,同时降低总抗氧化能力,包括 ROS、H2O2 的升高和超氧化物歧化酶 ( superoxide dismutase,SOD)的降低,在失重暴露后,血浆中 MDA 含量明显增加,最终引发氧化应激和脂质过氧化反应损伤。与上述发现一致的是,此项研究中模拟航天失重导致小鼠血清中H2O2 、MDA 的水平显著升高。经过 4 周的模拟失重应激后,小鼠的氧化应激水平显著增加,表明失重可能会扰乱机体的氧化还原平衡。 Nrf2 是细胞抗氧化反应的核心调节因子。在 ROS 刺激下,其易位到细胞核并被激活,从而通过转录上调下游抗氧化酶系统如HO-1。本研究中,模拟失重小鼠海马组织中Nrf2 / HO-1 通路蛋白水平的下调,表明模拟失重诱导的 Nrf2 / HO-1 通路抑制与脑内氧化应激损伤加剧密切相关,可能是其导致认知功能减退的重要机制之一。 mTOR 和 Sirtuin 家族(如 SirT1 和 SirT3) 调控线粒体能量代谢、ROS 清除及细胞生存,在神经功能维持中具有重要作用,其下调提示海马线粒体稳态受到严重破坏。 mTOR 信号 ( PmTOR/ mTOR) 调控蛋白合成、生长与自噬,介导线粒体生物发生及质量控制,构成神经元能量适应与氧化应激响应的核心枢纽。 mtTFA 是一种能影响 mtDNA 转录和复制的重要调节因子,mtTFA 缺失会导致线粒体功能紊乱,而线粒体功能紊乱与线粒体疾病、神经退行性疾病的发生发展密切相关。研究表明,mTOR 通过PINK1 / Parkin 通路促进线粒体吞噬,并与 mtTFA合作促进线粒体复制,从而维持线粒体结构和功能的完整性。位于线粒体中的 SirT1 是一种Ⅲ类烟酰胺腺嘌呤二核苷酸( nicotinamide adeninedinucleotide,NAD+)依赖性蛋白去乙酰化酶,其能够通过激活过氧化物酶体增殖物激活受体 γ 共激活因子 - 1α ( peroxisome proliferator-activatedreceptor γ coactivator-1α,PGC-1α),促进线粒体的生物合成,并协同 Nrf2 增强抗氧化反应;SirT3 则直接调控线粒体内抗氧化酶活性,并抑制ROS 产生。本研究中模拟失重诱导小鼠海马多个线粒体功能相关蛋白的表达下降,包括 PmTOR/ mTOR、mtTFA、SirT1 和 SirT3,提示小鼠海马组织中线粒体功能受损,代谢活性下降,抗氧化防御能力减弱,与学习记忆能力下降的重要分子机制相关。同时,神经炎症在模拟失重诱导的学习和记忆障碍中起着至关重要的病理作用,通常与氧化应激相互作用。 IL-33 属于 IL-1 细胞因子家族,具有细胞因子和转录调节因子的双重功能。作为一种转录因子,它与一系列信号通路结合,启动炎症基因的转录,最终导致炎性细胞因子/ 趋化因子的产生并触发免疫反应;COX-2作为典型的诱导型限速酶,其转录与翻译在应激、感染及神经炎症微环境中被核因子 κB( nuclearfactor kappa-B,NF-κB)、促分裂素原活化蛋白激酶( mitogen-activated protein kinase,MAPK) 等信号级联显著上调。这种酶优先催化花生四烯酸转化为前列腺素 E2 和其他类花生酸信号分子。其通过与 EP 受体偶联的 cAMP / PKA 途径放大 IL1β、肿瘤坏死因子-α 等促炎因子正反馈环路,此过程以 EP2-cAMP-PKA-CREB 轴为枢纽,通过抑制突触前谷氨酸释放、下调脑源性神经营养因子表达并阻碍长时程增强作用,从而损害神经元可塑性与学习记忆,阐明了炎症导致认知障碍的关键路径。这项研究发现,模拟失重小鼠海马组织中炎症相关蛋白 IL-33 和 COX-2 的表达显著增加,表明炎症反应的激活。模拟失重会导致神经系统中某些基因的差异表达(调节炎症反应、凋亡、转录)等,影响氧化应激平衡,导致学习、认知功能障碍等症状,这一结果与既往研究中关于失重环境下神经炎症加剧的结论一致,进一步证实炎症反应在失重诱导的认知功能障碍中具有关键作用。凋亡是学习与记忆功能障碍的核心病理基础之一,细胞凋亡不仅使细胞数量减少,还会破坏突触连接,解体神经网络,进而降低信息加工能力,削弱神经可塑性。高通量组学和神经病理学证据共同揭示了持续的氧化应激、受损的线粒体动力学和小胶质细胞介导的神经炎症形成了驱动中枢神经系统凋亡的中枢三联体。这种程序性细胞死亡主要通过线粒体途径 ( 细胞色素 C /Caspase-9)和死亡受体途径(Caspase-8)的协同激活来启动,并通过 Caspase-3 共同效应子级联放大。当细胞接收到诱导凋亡的信号后,外膜蛋白 Bax 的表达水平显著上调,这一过程直接导致Caspase-3 与 Caspase-9 的级联活化。 Bcl2 作为细胞凋亡的核心调控因子,其作用靶点位于线粒体,主要通过对线粒体功能的调控来影响内在凋亡途径。 Bcl2 抗凋亡蛋白家族成员通过与这些促凋亡蛋白形成异二聚体来抑制 Bax 和 Bcl2同源拮抗剂的促凋亡功能。本研究发现,在模拟失重小鼠中,海马中促凋亡蛋白 Caspase-3 和Caspase-8 的表达显著上调,而抗凋亡蛋白 Bcl2 的表达显著下调。这种 Bcl2 / Bax 平衡的破坏导致凋亡增加,进一步表明模拟失重促进小鼠和大鼠海马神经元的凋亡。海马体神经元数量的减少破坏了学习和记忆的神经基础,可能导致认知功能的逐渐下降。综上,模拟航天失重可以通过多种病理生理途径损害小鼠的学习和记忆能力。这些机制包括抑制 Nrf2 / HO-1 抗氧化途径,激活炎症反应,破坏mTOR 和 Sirtuin 调控的线粒体稳态,以及诱导海马神经元凋亡。这些方面相互作用,共同导致认知功能的下降。本研究为更深入地了解航天失重条件下认知功能障碍的发病机制提供了重要的实验证据,并为开发有针对性的保护措施(如抗氧化、抗炎和线粒体保护干预措施) 奠定了理论基础。未来的研究可能会进一步探索这些分子通路之间的相互作用,并验证潜在干预方法的有效性,以期为预防宇航员的认知功能障碍提供更强有力的支撑。来源：中国实验动物学报往期动物模型相关推文脓毒症小鼠模型制备及免疫抑制状态评价的研究进展脑卒中动物模型构建与评价方法评述无菌金黄地鼠糖尿病粪菌移植模型建立肝癌痛小鼠模型的建立与评价濒危到极危，海南长臂猿如何“逆天改命”走出灭绝边缘高创汇高圣生物·模式动物·药效学评价项目 ▶ 转基因模式动物|条件性敲除鼠|纯合子筛选 ▶ 肿瘤原位模型|心梗模型|MCAO脑梗模型|脊髓/神经损伤模型|衰老模型等药效学建模 ▶ 类器官|药代动力学|体外药理学|分子病理学|动物影像学|行为学|毒理学研究

2026-05-06

·PRNewswire

Life Science Instrumentation Market worth $92.53 billion by 2031 | MarketsandMarkets™

DELRAY BEACH, Fla., May 6, 2026 /PRNewswire/ -- According to MarketsandMarkets™, the Life Science Instrumentation Market is projected to grow from about USD 63.40 billion in 2025 to USD 92.53 billion by 2031, at a CAGR of 6.5%. Browse 250 market data Tables and 50 Figures spread through 300 Pages and in-depth TOC on "Electrosurgery Market - Global Forecast to 2031" Life Science Instrumentation Market Size & Forecast: Market Size Available for Years: 2025–2031 2025 Market Size: USD 63.40 billion 2031 Projected Market Size: USD 92.53 billion CAGR (2026–2031): 6.5% Life Science Instrumentation Market Trends & Insights: By technology, the other technologies segment is expected to dominate the market, with a share of 28.1% in 2025. By application, the research applications segment accounted for the largest share of 63.8% in 2025. By end user, the agriculture and food industries segment is expected to register the highest CAGR of 7.7% during the forecast period from 2025 to 2031. By region, the Asia Pacific market is expected to register the highest CAGR of 7.3% during the forecast period from 2025 to 2031. Download PDF Brochure @ The global life science instrumentation market is set to grow steadily through 2031, driven by several key trends. A major trend is the increasing adoption of advanced, hyphenated analytical instruments that offer greater precision and efficiency, particularly in drug discovery and development workflows. The increasing outsourcing of testing and analytical services to pharmaceutical and biopharmaceutical companies, as well as CDMOs and CROs, aims to reduce operational costs while ensuring regulatory compliance. Additionally, there is a growing reliance on sophisticated technologies such as mass spectrometry, advanced spectroscopy, and electrophoresis for applications including protein analysis, biomarker discovery, and quality control. Together, these trends are shaping a more technology-driven, cost-efficient, and innovation-focused landscape for the global life science instrumentation market. By technology, the spectroscopy segment is expected to register a significant growth rate over the forecast period. The life science instrumentation market is segmented into spectroscopy, chromatography, polymerase chain reaction (quantitative PCR, digital PCR), immunoassays, lyophilization, liquid handling systems, clinical chemistry analyzers, microscopy, flow cytometry, next-generation sequencing, centrifuges, electrophoresis, cell counting, and other technologies. The spectroscopy segment held the largest share of the life science instrumentation market in 2025. The growth of spectroscopy technology in life science instrumentation is largely driven by the rising need for accurate molecular characterization and detailed biomolecular analysis in both research and diagnostic settings. Continuous advancements in high-resolution detectors, laser systems, and automation are enhancing the sensitivity, precision, and throughput of analytical processes. Additionally, the expanding research focus on proteomics, metabolomics, and structural biology is accelerating the adoption of advanced spectroscopic techniques, including mass spectrometry, Raman spectroscopy, and infrared spectroscopy, for in-depth chemical and biological analysis. Request Sample Pages@ By application, the research applications segment accounted for the largest share of the life science instrumentation market in 2025. The life science instrumentation market is segmented into research applications, clinical & diagnostic applications, and other applications. The research applications segment held the largest share of the life science instrumentation market in 2025. A key trend shaping the life science instrumentation market is the growing focus on advanced research applications, particularly in genomics, proteomics, and metabolomics, which require highly sophisticated analytical and imaging technologies to study complex biological systems. This trend is further supported by increased funding from government bodies and academic institutions, as well as expanding collaborations between research organizations and the biopharmaceutical industry. Together, these factors are driving the adoption of cutting-edge life science instruments and contributing to overall market growth. By end user, the pharmaceutical & biotechnology companies segment accounted for the largest share of the life science instrumentation market in 2025. The life science instrumentation market is segmented into hospitals & diagnostic laboratories, pharmaceutical & biotechnology companies, academic & research institutes, agriculture & food industries, environmental testing laboratories, clinical research organizations, and other end users. The pharmaceutical & biotechnology companies segment held the largest share of the life science instrumentation market in 2025. The growing prominence of biologics, biosimilars, and personalized medicine has further increased demand for highly precise instruments for proteomics, genomics, and cell analysis. Moreover, rising regulatory requirements for data accuracy and product safety, along with advances in automation, high-throughput screening, and digital analytics, are fostering greater investment in advanced, sophisticated instrumentation. The Asia Pacific market is expected to register the highest growth in the market during the forecast period. The Asia Pacific life science instrumentation market is projected to record the highest growth from 2025 to 2031, driven by rapid advancements in biotechnology, pharmaceuticals, and academic research. Major industry players are expanding their manufacturing and R&D capabilities across countries such as China, India, Japan, and South Korea to meet the growing regional demand. Increasing government funding for life science research, rising healthcare expenditures, and the establishment of biopharma manufacturing hubs are further fueling market expansion. Additionally, the growing adoption of analytical and diagnostic instruments in clinical laboratories, coupled with a shift toward precision medicine and automation, is creating significant growth opportunities for global and regional players operating in the APAC life science instrumentation market. Inquire Before Buying@ Top Companies in Life Science Instrumentation Market: The Top Companies in Life Science Instrumentation Market include Thermo Fisher Scientific Inc. (US), Danaher Corporation (US), Agilent Technologies, Inc. (US), Waters Corporation (US), Shimadzu Corporation (Japan), Becton, Dickinson and Company (US), PerkinElmer Inc. (US), Bio-Rad Laboratories, Inc. (US), Bruker (US), and Hitachi High-Technologies Corporation (Japan), among others. Browse Adjacent Markets: Analytical and Scientific Instrumentation Market Research Reports & Consulting Related Reports: Digital PCR and qPCR Market - Global Forecast to 2029 Flow Cytometry Market - Global Forecast to 2033 Next-generation Sequencing Market - Global Forecast to 2031 Mass Spectrometry Market - Global Forecast to 2030 PCR Technologies Market - Global Forecast to 2030 About MarketsandMarkets™ MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report. MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe. 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MarketsandMarkets™ SalesPlay is an AI-driven Revenue Intelligence Co-Pilot designed to help revenue teams prioritize the right accounts, identify critical changes early, and surface opportunities ahead of demand, so pipeline builds naturally and deals close with greater consistency. To find out more, visit ™.com or follow us on Twitter, LinkedIn and Facebook. Contact: Mr. Rohan Salgarkar MarketsandMarkets™ INC. 1615 South Congress Ave. Suite 103, Delray Beach, FL 33445 USA: +1-888-600-6441 Email: [email protected] Visit Our Website: Logo: SOURCE MarketsandMarkets 21% more press release views with Request a Demo

2026-05-04

·PRNewswire

Biologics Safety Testing Market worth $9.66 billion by 2031 | MarketsandMarkets™

DELRAY BEACH, Fla., May 4, 2026 /PRNewswire/ -- According to MarketsandMarkets™, the Biologics Safety Testing is projected to grow from about USD 5.57 billion in 2026 to USD 9.66 billion by 2031, at a CAGR of 11.6%. Browse 260 market data Tables and 60 Figures spread through 270 Pages and in-depth TOC on 'Biologics Safety Testing Market- Global Forecast to 2031' Biologics Safety Testing Market Size & Forecast: Market Size Available for Years: 2025–2031 2026 Market Size: USD 5.57 billion 2031 Projected Market Size: USD 9.66 billion CAGR (2026–2031): 11.6% Biologics Safety Testing Market Trends & Insights: By offering, in 2025, the product segment had the largest share of 41.9%. Pharmaceutical & biotechnology companies dominated the biologics safety testing products market in 2025 with a share of 56.0%. North America accounted for the largest market share, by region, in 2025: 43%. Download PDF Brochure @ The growth of advanced modalities such as cell & gene therapies and mRNA products is a major driver of the biologics safety testing market. Additionally, the expanding pipeline of biologics and biosimilars, along with stringent and evolving regulatory requirements, is driving the market growth. By offerings, The Service segment accounted for the largest share of the global biologics safety testing market in 2025. Based on offerings, the biologics safety testing market is segmented into products and services. The services segment dominated the biologics safety testing market share in 2025, driven by increasing outsourcing to CROs and CDMOs, rising complexity of biologics, and the need for specialized expertise. The growing demand for end-to-end testing across development and manufacturing, along with stringent regulatory requirements, further supports the segment's leadership. Additionally, the expansion of cell and gene therapies and increasing biologics production continue to boost service adoption, reinforcing its dominant position in the global biologics safety testing market. Request Sample Pages @ By application, vaccine safety testing is estimated to be the fastest-growing service application segment in the biologics safety testing market. The global biologics safety testing service market is segmented by monoclonal antibodies & therapeutic proteins safety testing, vaccines safety testing, cellular & gene therapy safety testing, blood & blood products safety testing, and other applications. During the forecast period, the vaccines safety testing segment is projected to be the fastest-growing in the biologics safety testing services market, driven by increasing global immunization programs, rising vaccine production, and the continuous development of new and improved vaccines. Stringent regulatory requirements for batch release and quality assurance further accelerate demand for comprehensive safety testing solutions. North America accounted for the largest regional share in the global biologics safety testing market in 2025. North America accounted for the largest share of regional revenues in the biologics safety testing market and remains the primary growth engine. The region's dominance is driven by a high concentration of leading biopharmaceutical companies, advanced research infrastructure, and strong regulatory oversight from agencies such as the FDA. Increasing biologics production, rapid adoption of cell and gene therapies, and a robust clinical trials landscape further support demand for safety testing. Additionally, significant public and private funding, along with widespread outsourcing to CROs and CDMOs, positions the US as a key hub for innovation and market growth. Inquire Before Buying @ Top Companies in Biologics Safety Testing Market: The Top Companies in Biologics Safety Testing Market include Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Lonza (Switzerland), FUJIFILM Corporation (Japan), Sartorius AG (Germany), F. Hoffmann-La Roche Ltd. (Switzerland), Charles River Laboratories (US), bioMérieux (France), Maravai LifeSciences (US), WuXi AppTec (China), SGS Société Générale de Surveillance SA (Switzerland), Sotera Health (US), Samsung Biologics (South Korea), GenScript (US), Agilent Technologies, Inc. (US), Syngene International Limited (India), Eurofins Scientific (Luxembourg), Laboratory Corporation of America Holdings (US), Bio-Rad Laboratories, Inc. (US), and QIAGEN (Netherlands). Browse Adjacent Markets: Biotechnology Market Research Reports & Consulting Related Reports: Monoclonal Antibody Therapeutics Market - Global Forecast to 2029 Vaccines Market - Global Forecast to 2030 Gene Therapy Market - Global Forecast to 2032 Cell Therapy Technologies Market - Global Forecast to 2030 Biosimilars Market - Global Forecast to 2035 About MarketsandMarkets™ MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report. MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe. Today, 80% of Fortune 2000 companies rely on MarketsandMarkets, and 90 of the top 100 companies in each sector trust us to accelerate their revenue growth. With a global clientele of over 13,000 organizations, we help businesses thrive in a disruptive ecosystem. The B2B economy is witnessing the emergence of $25 trillion in new revenue streams that are replacing existing ones within this decade. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing. Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts. 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