我国生物制品通用名命名原则的修订

对我国生物制品通用名命名原则进行了立题研究,旨在建立和完善我国生物制品通用名称命名原则。通过分析我国生物制品通用名现状、存在的问题及新型生物药发展趋势,研究比较了国际上具有主导性的药品通用名命名体系,并参照世界卫生组织国际非专利名称(WHO INN)命名原则,在中文语言识别的基础上,对我国生物制品通用名称命名原则提出了具体的增修订意见。     

聚乙二醇化重组人粒细胞刺激因子及其药品通用名称命名

有越来越多的聚乙二醇修饰人粒细胞刺激因子研发上市。为适应这类制品的发展,中国药品通用名命名原则也需要不断更新修订。简要介绍了聚乙二醇修饰蛋白技术以及WHO国际非专利药品名(INN)命名委员会对这类制品的命名情况,讨论了我国对这类制品的药品通用命名原则和方法,建议对聚乙二醇化不同的修饰形式在名称上适当加以区分,并注意加强与INN命名委员会的交流合作。     

聚乙二醇重组人干扰素及其药品通用名称命名

越来越多的聚乙二醇修饰蛋白研发上市。为适应这类制品的发展,与之相关的中国药品通用名命名原则也需要不断更新。介绍了PEG修饰蛋白技术的发展以及WHO国际非专利药品名(INN)命名委员会对这类制品的命名情况,讨论了我国对这类制品的命名原则和方法。     

生物多样性国际发展援助作用、现状与中国行动思考: 基于CBD履约视角

生物多样性国际发展援助是在全球范围达成《生物多样性公约》(Convention on Biological Diversity, CBD)目标和联合国可持续发展目标(Sustainable Development Goals, SDGs)的主要途径, 也是中国在全球范围践行习近平生态文明思想、参与国际环境治理、维护中国海外发展利益和构建良好国际形象的重要政策工具。当前中国生物多样性对外援助理论和实践尚处于起步阶段, 研究基于对全球生物多样性官方发展援助(Official Development Assistance, ODA)融资水平分析, 以及全球主要多边和双边生物多样性援助组织政策经验总结, 从援助融资、总体布局、重点实施三个层面提出中国生物多样性对外援助总体规划和行动建议, 以期为即将于2021年在云南举办的COP15大会上, 中国作为东道国提出未来十年全球生物多样性治理国际倡议和国家行动计划提供理论支持。     

长江大保护事业呼吁重视植物遗传多样性的保护和可持续利用

正1植物遗传资源应当是今后生物多样性保护的重点生物多样性是人类赖以生存和发展的物质基础,具有巨大的生态服务功能。全球生物多样性每年为人类创造的服务价值远高于经济生产总值,据Costanza等(1997,2014)研究,1995年全球生态系统服务功能价值为33万亿美元,当时全球国民生产总值(GNP)为18万亿美元;2011年全球生态系统服务功能价值达125万亿美元,而全球GNP为68.85万亿     

药明生物-赛多利斯中国联合实验室正式启动

正药明康德集团企业药明生物与赛多利斯中国近日在上海启动了"联合实验室",以进一步提升中国在全球生物新药研发的地位,实现更多生物药更快进入中试及生产阶段,提高中国生物药的研发能力和质量。赛多利斯亚太区高级副总裁Joerg Lindenblatt博士表示,赛多利斯将从加速进入临床、提高蛋白质表达水平、质量源于设计和稳健生产等四个方面,支持中国生物制药行业的快速发展。赛多利斯与药明生物强强联手,将为双     

全球生物产业发展现状及政策启示

生物经济时代正在引发人类新一波技术和产业革命,并已成为了全球主要发达国家和新兴经济体抢占的制高点。文中从生物医药产业、转基因作物种植产业、生物能源产业以及生物基化学品产业4个角度分析了全球生物产业发展的时空特征,概括总结了全球生物产业发展的主要特点,并进一步针对我国生物产业发展中存在的瓶颈问题提出政策建议,对我国生物经济的未来发展具有指导意义。     

美国生物类似药的使用与医疗保险支付策略分析——基于Pfizer vs. Johnson案的思考 *

近几年全球生物类似药发展如火如荼,各国出台积极政策响应与推动生物类似药的研发和应用,大型制药企业也通过一系列对生物医药公司的收购完成生物类似药研发先机的抢占。以Pfizer vs. Johnson案为研究对象,对美国生物类似药的保障政策、诉讼案件发展和系列焦点问题进行整体描述与深入分析。研究发现,来自原研企业的竞争压力及临床对生物类似药可替代性的质疑与保守态度,都在一定程度上对类似药的应用和推广构成威胁,而其价格优势和越来越明朗的政策环境使得生物类似药的未来可期。     

生物谱系命名法规简评

基于林奈命名法和林奈分类系统的生物分类系统已经存在250多年并仍然为广大生物学工作者使用,由此产生的国际动物、植物、细菌的命名法规亦执行了100年(1905年,国际植物命名法规第1版产生),并在不断修订.随着分类方法的不断进步,林奈分类系统的一些缺陷逐渐显露,一种被称为生物谱系命名法规(PhyloCode)的新的命名法出现在人们眼前.这种基于系统发育系统学的命名法规一经问世就引起诸多争论,但是,作为一种新的命名法规,无论与传统的命名法规融合还是独立发展,对于已有的分类系统都是一个新的机遇和挑战.     

资讯动态

正全球生物塑料产量2022年预计增至244万吨欧洲生物塑料协会(European Bioplastics)于2017年11月29日表示,全球生物塑料年产能将从2017年约205万吨增加至2022年约244万吨。欧洲生物塑料协会称,一些生物聚合物如聚乳酸(PLA)和聚羟基脂肪酸酯(PHA)是增长的主要推动力。该协会主席Francois de Bie表示,预计在未来五年全球生物塑料市场将增长20%。     

The INNs and outs of antibody nonproprietary names

An important step in drug development is the assignment of an International Nonproprietary Name (INN) by the World Health Organization (WHO) that provides healthcare professionals with a unique and universally available designated name to identify each pharmaceutical substance. Monoclonal antibody INNs comprise a –mab suffix preceded by a substem indicating the antibody type, e.g., chimeric (-xi-), humanized (-zu-), or human (-u-). The WHO publishes INN definitions that specify how new monoclonal antibody therapeutics are categorized and adapts the definitions to new technologies. However, rapid progress in antibody technologies has blurred the boundaries between existing antibody categories and created a burgeoning array of new antibody formats. Thus, revising the INN system for antibodies is akin to aiming for a rapidly moving target. The WHO recently revised INN definitions for antibodies now to be based on amino acid sequence identity. These new definitions, however, are critically flawed as they are ambiguous and go against decades of scientific literature. A key concern is the imposition of an arbitrary threshold for identity against human germline antibody variable region sequences. This leads to inconsistent classification of somatically mutated human antibodies, humanized antibodies as well as antibodies derived from semi-synthetic/synthetic libraries and transgenic animals. Such sequence-based classification implies clear functional distinction between categories (e.g., immunogenicity). However, there is no scientific evidence to support this. Dialog between the WHO INN Expert Group and key stakeholders is needed to develop a new INN system for antibodies and to avoid confusion and miscommunication between researchers and clinicians prescribing antibodies.     

Patient Safety in Medication Nomenclature: Orthographic and Semantic Properties of International Nonproprietary Names

Background

Confusion between look-alike and sound-alike (LASA) medication names (such as mercaptamine and mercaptopurine) accounts for up to one in four medication errors, threatening patient safety. Error reduction strategies include computerized physician order entry interventions, and ‘Tall Man’ lettering. The purpose of this study is to explore the medication name designation process, to elucidate properties that may prime the risk of confusion.

Methods and Findings

We analysed the formal and semantic properties of 7,987 International Non-proprietary Names (INNs), in relation to naming guidelines of the World Health Organization (WHO) INN programme, and have identified potential for errors. We explored: their linguistic properties, the underlying taxonomy of stems to indicate pharmacological interrelationships, and similarities between INNs. We used Microsoft Excel for analysis, including calculation of Levenshtein edit distance (LED). Compliance with WHO naming guidelines was inconsistent. Since the 1970s there has been a trend towards compliance in formal properties, such as word length, but longer names published in the 1950s and 1960s are still in use. The stems used to show pharmacological interrelationships are not spelled consistently and the guidelines do not impose an unequivocal order on them, making the meanings of INNs difficult to understand. Pairs of INNs sharing a stem (appropriately or not) often have high levels of similarity (<5 LED), and thus have greater potential for confusion.

Conclusions

We have revealed a tension between WHO guidelines stipulating use of stems to denote meaning, and the aim of reducing similarities in nomenclature. To mitigate this tension and reduce the risk of confusion, the stem system should be made clear and well ordered, so as to avoid compounding the risk of confusion at the clinical level. The interplay between the different WHO INN naming principles should be further examined, to better understand their implications for the problem of LASA errors.     

Rethinking the INN system for therapeutic antibodies

In the context of a possible revision of the International Nonproprietary Names (INN) system of recombinant monoclonal antibodies, which is saturated, we propose several avenues of reflection driven by the primary goal of the INN, information of health-care professionals. Clinical considerations argue for an abandon of the substems A (target category) and B (origin category), which lengthen the INN without real added-value. On the contrary, new substems or suffixes are required to alert on the absence/presence of an Fc portion and/or multispecificity, which are essential from a pharmacological point of view. Moreover, we think it necessary to explicitly mention Fc variations since they could influence the pharmacology of these biopharmaceuticals, and hence their efficacy and side-effects. Besides indicating the subclass/isotype in the documents easily accessible to health care professionals, we propose to systematically describe both the natural variations (allotypes) by using the Gm (G marker) system, and the artificial variations by using a Ge (G engineering) system that is discussed here and could apply to all IgG constant domains (tentatively called the Fy portion).     

The effect of systemic Isotretinoin on salivary tissue inhibitors of metalloproteinases 1 and 2 and salivary flow rate in periodontal disease

AimsTo evaluate and compare changes in salivary flow rate and salivary levels of TIMP-1 and TIMP-2 in individuals taking oral Isotretinoin (INN) with those who do not take INN. To assess the variation in TIMP-1 and TIMP-2 as well as salivary flow rate observed at different stages of periodontal disease in comparison to those observed in the case of healthy periodontium.Materials and methodsAn examiner-blind case-control study involving 180 human adults divided into six groups based on their periodontal status. Clinical parameters, including pocket depth, clinical attachment level, and bleeding on probing were measured at six sites per tooth. Whole unstimulated saliva samples were collected from all subjects to evaluate salivary flow rate (SFR). Salivary TIMP-1 and TIMP-2 levels were detected using enzyme-linked immunosorbent assay (ELISA). Data were analyzed using IBM SPSS Software. The Kruskal Wallis test and Mann-Whitney U-tests were employed to verify any significant differences between the groups for all parameters. Multi-regression analysis was performed for each parameter tested in each group. All tests were compared at a significance level of 0.05.ResultsSFR was statistically significantly lower among all INN groups in comparison to the control groups (P < 0.001). TIMP-1 and TIMP-2 were significantly higher in all INN groups in comparison to the control groups, in both gingivitis cases (P = 0.004, P < 0.0001 respectively) and periodontitis cases (P < 0.0001).ConclusionAlthough INN reduces salivary flow rate, the findings of the present study revealed that it had an anti-inflammatory effect in periodontal biomarkers. Specifically, it was positively correlated with an elevation of salivary TIMP-1 and TIMP-2. Hence, INN might be a future additive medication to be further evaluated for the treatment of periodontal diseases.     

The pros and cons of interferons for oncolytic virotherapy

Interferons (IFN) are potent immune stimulators that play key roles in both innate and adaptive immune responses. They are considered the first line of defense against viral pathogens and can even be used as treatments to boost the immune system. While viruses are usually seen as a threat to the host, an emerging class of cancer therapeutics exploits the natural capacity of some viruses to directly infect and kill cancer cells. The cancer-specificity of these bio-therapeutics, called oncolytic viruses (OVs), often relies on defective IFN responses that are frequently observed in cancer cells, therefore increasing their vulnerability to viruses compared to healthy cells. To ensure the safety of the therapy, many OVs have been engineered to further activate the IFN response. As a consequence of this IFN over-stimulation, the virus is cleared faster by the immune system, which limits direct oncolysis. Importantly, the therapeutic activity of OVs also relies on their capacity to trigger anti-tumor immunity and IFNs are key players in this aspect. Here, we review the complex cancer–virus–anti-tumor immunity interplay and discuss the diverse functions of IFNs for each of these processes.     

MEG Source Localization Using Invariance of Noise Space

We propose INvariance of Noise (INN) space as a novel method for source localization of magnetoencephalography (MEG) data. The method is based on the fact that modulations of source strengths across time change the energy in signal subspace but leave the noise subspace invariant. We compare INN with classical MUSIC, RAP-MUSIC, and beamformer approaches using simulated data while varying signal-to-noise ratios as well as distance and temporal correlation between two sources. We also demonstrate the utility of INN with actual auditory evoked MEG responses in eight subjects. In all cases, INN performed well, especially when the sources were closely spaced, highly correlated, or one source was considerably stronger than the other.     

Improving the suitability of glass fiber filters for use as culture supports

Summary Commercially available glass fiber filters are useful as physical supports for cultures; however, as received from the manufacturers, the filters frequently contain substances that render them unsuitable for some types of experimental studies. These substances contribute to the formation of precipitates in the culture media, alter the media pH, and repress synchronous development among embryo cultures of eastern white pine (Pinus strobus L.). A simplified technique was developed to remove the contaminants and to saturate the cation exchange sites on the glass fibers with specific ions. The use of trade, product, or corporation names in this publication is for the information and convenience of the reader. Such use does not constitute an official endorsement or approval by the U.S. Department of Agriculture or the Forest Service of any product or service to the exclusion of others that also may be suitable.