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mRNA疫苗生产工艺及质量控制的研究进展

中国新药杂志 2024年第11期33卷 1109-1114页

作者：唐琪施金荣邢沛东聂希霖杨晓明武汉生物制品研究所有限责任公司病毒性疫苗研究二室武汉430207 武汉生物制品研究所有限责任公司质量控制室武汉430207 武汉生物制品研究所有限责任公司质量保证部武汉430207 中国生物技术股份有限公司北京100029

由于mRNA疫苗具有结构简单、构建快速及保护效果好等特点,在应对病原体变异及新发传染病方面表现出了明显优势,作为疫苗研发的新一代技术引起了各方的广泛关注,但是其在生产工艺和质量控制方面还缺乏系统的研究和报道。本综述对mRNA疫... 详细信息

由于mRNA疫苗具有结构简单、构建快速及保护效果好等特点,在应对病原体变异及新发传染病方面表现出了明显优势,作为疫苗研发的新一代技术引起了各方的广泛关注,但是其在生产工艺和质量控制方面还缺乏系统的研究和报道。本综述对mRNA疫苗制备工艺的主要流程、工艺特征进行了阐述,根据各国指南文件及相关研究,对其制备工艺中起始材料、原液、中间制剂及成品的关键质量控制要素进行梳理,并对其检测方法进行总结归纳,为mRNA疫苗的研发与制备提供参考。

关键词： mRNA疫苗生产工艺质量控制检测方法

Shape effect of nanochannels on water mobility

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Frontiers of physics 2016年第6期11卷 175-182页

Confinement can induce unusual behaviors of water. Inspired by the fabrication of carbon nanotubes with noncircular cross sections, we performed molecular dynamics simulations to investigate the mobilities of water confined in carbon nanochannels with circular, square, and equilateral triangular cross sections over a variety of dimensions. We find that water exhibits disparate mobilities across different types of channels below 0.796 nm(2). Notably, compared with the other two channels, water in equilateral triangular channels displays the greatest mobilities. Moreover, at 0.425 nm(2), different ordered structures are found in the three channels, and water inside the square channel exhibits an extremely low mobility. It is also found that above 0.796 nm(2), the mobilities along the tube axis of water converge to that of the bulk. These phenomena are understood by analyzing the structure, dynamics, and hydrogen bonding of water. Our work explores the mobilities of water across noncircular carbon nanochannels, which may expand the prospect of noncircular nanochannels in scientific studies and practical applications, such as desalination and drug delivery.

关键词： molecular dynamics simulations mobility noncircular nanochannel water

Role of confinement in water solidification under electric fields

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Frontiers of physics 2015年第5期10卷 59-67页

作者： Guo-xi nie Yu Wang Ji-Ping Huang Department of Physics State Key Laboratory of Surface Physics and Collaborative Innovation Center of Advanced Microstructures Fudan University Shanghai 200433 China Department of Physics Zhejiang Agriculture and Forestry University Hangzhou 311300 China Department of Physics State Key Laboratory of Surface Physics and Collaborative Innovation Center of Advanced Microstructures Fudan University Shanghai 200433 China

In contrast to the common belief that confinement promotes water solidification, here we show by molecular dynamics simulations that confinement can impede water solidification under electric fields. The behavior is evidenced by the increase in critical electric field strength for water solidifi- cation as the confinement progresses. We also show that the solidification occurs more easily with a parallel field than a perpendicular one. We understand and generalize these results by developing an energy theory incorporated with the anisotropic Clausius-Mossotti equation. It is revealed that the underlying mechanism lies in the confinement effect on molecules＇ electro-orientations. Thus, it be- comes possible to achieve electro-freezing （i.e., room-temperature ice） by choosing both confinement and electric fields appropriately.

关键词： molecular dynamics simulations water electric fields confinement

Effects of holding time and Zener-Hollomon parameters on deformation behavior of cast Mg-8Gd-3Y alloy during double-pass hot compression

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Journal of Materials Science & Technology 2018年第11期34卷 2035-2041页

作者： xi nie Shuai Dong Fenghua Wang Li Jin Jie Dong National Engineering Research Center of Light Alloy Net Forming School of Material Sciences and EngineeringShanghai Jiao Tong University

Double-pass hot compression tests were carried out over a wide range of holding time（0–180 s） and Zener-Hollomon parameter（1.6 E15–1.3 E20） to study the deformation behavior of cast Mg-8 Gd-3 Y *** flow curves show obvious work hardening and strain softening stages, leading to the peak stress of double-pass hot compression. Holding time and Zener-Hollomon parameter can significantly affect the second pass peak stress. It is found that increasing the holding time can cause a higher peak stress in the second pass deformation. The second pass stress reaches the peak stress of 71 MPa at ZenerHollomom parameter of 1.6 E15. When the parameter rises to 1.3 E20, the second pass peak goes up to237 MPa. In addition, the second pass peak stress is significantly higher than the unloading stress, which is opposite to the flow behavior of aluminum alloys. Residual stored deformation energy caused by the first pass deformation could be consumed by metadynamic recrystallization. Therefore, more strain energy is required for subsequent dynamic recrystallization, resulting in hardening behavior. A hardening fraction is defined to describe the deformation behavior quantitatively, which shows a positive correlation with the metadynamic recrystallization fraction. The metadynamic recrystallization leads to grain growth at the inter pass holding stage, diminishing dynamic recrystallization nucleation positions in the second pass deformation.

关键词： Mg-8Gd-3Y magnesium alloy Double pass hot compression Deformation behavior Metadynamic recrystallization

隧道烘箱确认的现场检查发现问题分析及改进对策探讨

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中国食品药品监管 2024年第3期 108-113页

作者：聂希霖李茜宋弘王卫武汉生物制品研究所有限责任公司国药奇贝德(上海)工程技术有限公司

隧道烘箱是无菌制剂生产的关键设备,承担着灭菌、除热原等功能,通常是现场检查的重点关注对象。本文汇总了2021年世界卫生组织对我国疫苗生产企业的预认证现场检查和2020~2022年我国监管部门开展生物制品检查时针对隧道烘箱确认提出的... 详细信息

隧道烘箱是无菌制剂生产的关键设备,承担着灭菌、除热原等功能,通常是现场检查的重点关注对象。本文汇总了2021年世界卫生组织对我国疫苗生产企业的预认证现场检查和2020~2022年我国监管部门开展生物制品检查时针对隧道烘箱确认提出的典型问题,并分析问题产生原因,探讨整改措施,旨在为进一步提升隧道烘箱确认的科学性合理性提供借鉴。

关键词：隧道烘箱确认问题分析改进对策无菌保障

Quantification of Trace Amounts of Impurities in High Purity Cobalt by High Resolution Inductively Coupled Plasma Mass Spectrometry

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Chinese Chemical Letters 2006年第8期17卷 1077-1080页

作者： Hua Lin xiE xi Du nie You Gen TANG Department of Chemistry Hunan Institute of Technology Hengyang 421008 School of Chemistry and Chemical Engineering Central south university Changsha 410083

An analytical method using high resolution inductively coupled plasma mass spectrometry （HR-ICP-MS） for rapid simultaneous determination of Be, Mg, Al, Ti, V, Cr, Mn, Fe, Ni, Cu, Zn, Ga, Ge, As, Se, Mo, Ag, Cd, Sn, Sb, Ba, Pt, Au and Pb in high purity cobalt was described. Sample digestions were performed in closed microwave vessels using HNO3 and HCl. The matrix effects due to the presence of excess HCl and Co were evaluated. The usefulness of high mass resolution for overcoming some spectral interference was demonstrated. The optimum conditions for the determination was tested and discussed. Correction for matrix effects, Sc, Rh and Bi were used as internal standards. The detection limits is 0.003-0.57 μg/g, the recovery ratio is 92.2%-111.2%, and the RSD is less than 3.6%. The method is accurate, quick and convenient. It has been applied to the determination of trace impurities in high purity cobalt with satisfactory results.

关键词： High resolution inductively coupled plasma mass spectrometry high purity cobalt,trace impurities matrix effect spectral interference internal standards.

Enhanced removal of phosphonates from aqueous solution using PMS/UV/hydrated zirconium oxide process

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Chinese Chemical Letters 2023年第4期34卷 384-389页

作者： Shunlong Pan xi nie xinrui Guo Hao Hu Biming Liu Yongjun Zhang School of Environmental Science and Engineering Nanjing Tech UniversityNanjing 210009China College of Environment Hohai UniversityNanjing 210098China State Key Joint Laboratory of Environment Simulation and Pollution Control School of EnvironmentTsinghua UniversityBeijing 100084China

Traditional treatment processes cannot completely remove phosphonates in circulating cooling water by one-step method. Herein, we designed peroxymonosulfate/UV irradiation/hydrated zirconium oxide(PMS/UV/HZO) coupling process to enhance the phosphonates removal. In particular, nitrilotrismethylenephosphonic acid(NTMP) removal efficiency by PMS/UV/HZO process was much higher than that of PMS/UV process, UV/HZO process and other processes in comparison experiments. Specifically,almost 97.2% NTMP in water was degraded, and the total phosphorous(TP) reduced from 9.3 mg/L to 0.26 mg/L at pH 7 within 180 min. TP removal efficiency still reached above 90% after 5 cycles adsorptiondesorption of HZO. Moreover, Cl^(-), NO_(3)-and SO_(4)^(2-)ions all had negligible effect on NTMP removal. During the process, NTMP was first destroyed to form phosphates and other intermediates by the reactive oxygen species(ROS), then phosphates were in situ immobilized via HZO adsorption. Sulfate radical(SO_(4)^(·-))has been confirmed to be the major ROS in the reaction system by quenching experiment and electron paramagnetic resonance(EPR) characterization. And the excellent selective adsorption capacity of HZO for phosphate produced was attributed to the strong inner-sphere coordination between H_(2)PO_(4)-/HPO_(4)^(2-)and Zr-OH on the surface of HZO. These results suggest that PMS/UV/HZO process is a promising technique for enhanced phosphonates decontamination.

关键词： Phosphonates Peroxymonosulfate UV ROS Adsorption

Traditional Chinese Medicine Integrated Responsive Microneedles for Systemic Sclerosis Treatment

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Research 2024年第1期2023卷 139-147页

作者： xi Luan xiaoxuan Zhang Min nie Yuanjin Zhao Department of Rheumatology and Immunology Nanjing Drum Tower HospitalSchool of PharmacyClinical College of Traditional Chinese and Western MedicineNanjing University of Chinese MedicineNanjing 210023China State Key Laboratory of Bioelectronics School of Biological Science and Medical EngineeringSoutheast UniversityNanjing 210096China

Traditional Chinese medicine,such as Tripterygium wilfordii and Paeonia lactiflora,has potential values in treating systemic sclerosis(SSc)and other autoimmune diseases,while their toxic side effect elimination and precise tropical drug delivery are still ***,we present multiple traditional Chinese medicine integrated photoresponsive black phosphorus(BP)microneedles(MNs)with the desired features for the SSc *** employing a template-assisted layer-by-layer curing method,such MNs with triptolide(TP)/paeoniflorin(Pae)needle tips and BP-hydrogel needle bottoms could be well *** combined administration of TP and Pae can not only provide anti-inflammatory,detoxification,and immunomodulatory effects to treat skin lesions in the early stage of SSc but also remarkably reduce the toxicity of single drug ***,the additive BPs possess good biocompatibility and near-infrared(NIR)responsiveness,imparting the MN photothermal-controlled drug release *** on these features,we have demonstrated that the traditional Chinese medicine integrated responsive MNs could effectively improve skin fibrosis and telangiectasia,reduce collagen deposition,and reduce epidermal thickness in the SSc mouse *** results indicated that the proposed Chinese medicine integrated responsive MNs had enormous potential in clinical therapy of SSc and other diseases.

关键词： needle precise template

Matrix Effects and Behaviors of Elements in Oxalic Acid Medium by Inductively Coupled Plasma Mass Spectrometry

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Chinese Chemical Letters 2006年第7期17卷 945-948页

作者： Hua Lin xiE Yu Jie LI xi Du nie Li Bo LI Department of Chemistry Hunan Institute of Technology Hengyang 421008 College of Chemistry and Chemical Engineering Central south University Changsha 410083

The influence of different concentration of oxalic acid matrix on elemental inductively coupled plasma mass spectrometry （ICP-MS） has been investigated. It has been proved that the sensitivity of analytes can be significantly enhanced by adding small amounts of oxalic acid medium with adjusted nebulizer flow-rate gas, especially for the elements with ionization potential between 9 and 11 eV. Oxalic acid, as an enhancement agent, can be used to compensate the signal depression caused by inorganic matrix and to improve the detection limits about two to eight times, for the hard-to-ionize elements in ICP-MS determination.

关键词： ICP-MS oxalic acid enhancement effect.