美国生物制品生产变更管理的研究及其对我国的启示

正在药品生产过程中,生产企业经常会对已上市生物制品的工艺、设备、设施、质量控制等进行变更。由于生物制品具有特殊性以及生产变更对其安全性和/或有效性的潜在影响较大,因此美国FDA对生物制品生产变更的管理要比一般药品严格。美国法律法规和指南已对部分生物制品的生产变更(chemistry,     

生产场地变更前后灭菌注射用水质量可比性分析

目的通过可比性分析确保灭菌注射用水生产场地变更前后质量的一致性。方法应用风险评估的方法对灭菌注射用水生产场地变更前后的材料、厂房设施、人员、生产工艺进行可比性分析,并对产品质量参数及稳定性试验的结果进行统计学分析。结果确认灭菌注射用水生产场地变更前后的材料及人员均一致,且确认厂房设施及生产工艺发生了变更,需经变更后连续3批上市规模的灭菌注射用水进行验证。生产场地变更后连续生产的3批产品与变更前连续2年生产的灭菌注射用水的关键质量指标p H、电导率、不挥发物的检定结果差异无统计学意义(P0.05);3批灭菌注射用水加速稳定性试验6个月内p H为5.0~7.0,电导率≤25μS/cm(25℃),不挥发物≤1 mg。结论灭菌注射用水生产场地变更前后质量一致,均符合《中国药典》二部(2010版)的标准。     

疫苗生产场地变更质量可比性研究的总体思考

由于疫苗生产产业化和法规升级等因素的要求,疫苗生产场地需要进行变更。可比性研究有利于控制场地变更对疫苗安全性、有效性带来的风险,是变更成功的桥梁。本文结合国内外技术指导原则的解读和疫苗产品的特点,对我国疫苗场地变更的质量可比性研究作一综述。     

广东省已上市化学药品备案审查情况及案例分析

通过整理我省2021～2022年已上市化学药品备案品种的申报情况,梳理典型案例和存在问题,为申报企业拟开展变更研究工作提供指导和帮助。方法：结合上市后备案品种的审查情况,从变更事项及变更内容、变更研究验证以及结果评估等方面,对变更研究中审查关注点和存在的问题进行分析讨论。结果与结论：从研究内容完整性、结果支持性等方面评价化学药品上市后变更研究工作完成情况。持有人为变更的主体责任人,加强变更管理、控制变更风险,建议持有人强化对药品法律法规的学习和掌握,形成新的研发思路,指导新化学药的开发,共同努力促进我省药品行业高质量发展。     

注射剂类药品生产工艺和处方核查工作启动

为加强药品生产工艺和处方变更的监管，进一步规范注射剂类药品生产秩序，解决药品生产企业不按照注册申报的工艺和处方生产、变更工艺和处方不按规定研究和申报的问题，国家食品药品监管局决定开展注射剂类药品生产工艺和处方核查工作。国家食品药品监督管理局8月10日印发《关于开展注射剂类药品生产工艺和处方核查工作的通知》，决定开展注射剂类药品生产工艺和处方核查工作，并制定了《注射剂类药品生产工艺和处方核查工作方案》。[第一段]     

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正《中国生物制品学杂志》为报道我国生物制品研究开发重大成果和国内外最新进展的国内唯一的生物制品专业学术期刊。由国家卫生部主管,中华预防医学会和长春生物制品研究所有限责任公司主办,是中华预防医学会系列杂志之一,月刊。本刊主要刊载生物制品和生物技术产品相关领域,如预防医学、免疫学、微生物学、生物化学、流行病学、临床医学等方面的研究、生产、使用和质控等学术文章。在选择来稿时注     

欢迎订阅《中国生物制品学杂志》

正《中国生物制品学杂志》于1988年创刊,由中华人民共和国卫生部主管,系中华预防医学会系列杂志之一,为报道我国生物制品研究开发重大成果和最新进展的国内唯一生物制品专业学术期刊。主要刊载生物制品和生物技术产品相关领域,如预防医学、免疫学、微生物学、生物化学、流行病学、临床学等方面的研究、生产、使用和质控等学术文章。主要设有     

欢迎订阅《中国生物制品学杂志》

<正>《中国生物制品学杂志》于1988年创刊,由中华人民共和国卫生部主管,系中华预防医学会系列杂志之一,为报道我国生物制品研究开发重大成果和最新进展的国内唯一生物制品专业学术期刊。主要刊载生物制品和生物技术产品相关领域,如预防医学、免疫学、微生物学、生物化学、流行病学、临床学等方面的研究、生产、使用和质控等学术文章。主要设有     

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<正>《中国生物制品学杂志》为报道我国生物制品研究开发重大成果和国内外最新进展的国内唯一的生物制品专业学术期刊。由国家卫生部主管,中华预防医学会和长春生物制品研究所有限责任公司主办,是中华预防医学会系列杂志之一,月刊。本刊主要刊载生物制品和生物技术产品相关领域,如预防医学、免疫学、微生物学、生物化学、流行病学、临床医学等方面的研究、生产、使用和质控等学术文章。在选择来稿时注     

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<正>《中国生物制品学杂志》为报道我国生物制品研究开发重大成果和国内外最新进展的国内唯一的生物制品专业学术期刊。由国家卫生部主管,中华预防医学会和长春生物制品研究所有限责任公司主办,是中华预防医学会系列杂志之一,月刊。本刊主要刊载生物制品和生物技术产品相关领域,如预防医学、免疫学、微生物学、生物化学、流行病学、临床医学等方面的研究、生产、使用和质控等学术文章。在选择来稿时注     

低微生物风险化妆品的风险评估和鉴定研究新进展

概述了国内外低微生物风险化妆品的风险评估和鉴定研究的新进展,并介绍了风险评估的原则、方法、关键因子（包括产品成分、生产条件、包装及这些因素的综合作用）和鉴定结果。其通常可被作为选择采用何种程度的测试才可确保产品质量的指南。     

Analytical strategies for assessing comparability of biosimilars

Biosimilar products are required by regulatory authorities to have appropriate and comparable quality, safety and efficacy with a reference biologic product. The analytical techniques that are available to manufacturers of biosimilar medicines are well advanced and present a range of options to characterize the products and compare them with the relevant marketed reference product. This variety of analytical methods can be used to investigate the attributes of a candidate biosimilar and a reference biologic, and ensures that orthogonal methods can be deployed to characterize a single attribute, facilitating rigorous structural characterization and physicochemical evaluation. These analytical methodologies not only enable evidence for bio‐comparability to be amassed but also enable a developer of biosimilars to incorporate risk mitigation into the development strategy. This review discusses the analytical techniques available to support comparability testing, the handling of reference material and the strategic aspects to commercializing biosimilar or follow‐on biological medicinal products. Copyright © 2011 Society of Chemical Industry     

Toxicological Evaluation of Biotechnology Products – A Regulatory Viewpoint

Since the only recent recognition that toxicological evaluation biotechnology derived products by standard toxicological procedures may be inadequate, unpredictive or even impossible to perform, development of safety assessment has moved in two directions: 1. A Council Directive of the European Community has been enacted as of Juli 1987 (87/22/EEC). Thereby hormones, cytokines and other regulatory factors – blood products – monoclonal antibodies – vaccines derived by biotechnology methods submitted for obtaining marketing authorization will be dealt with at the CPMP level beyond national submission. 2. To allow separation of quality problems (e.g. identity, purity, determination of contaminants possibly encountered from the novel processes used in their manufacture, and from the complex structural and biological characteristics of the products) from those to be addressed by “pre-clinical” testing, Notes for Guidance (EEC) have been finalized (quality) or are under preparation (pre-clinical). For the latter an approach is sought which will hopefully allow the development of safe compounds employing those experimental approaches fit for each product (case by case approach). The current standing of this draft Note for Guidance will be presented.     

火炸药生产质量评定指标体系及定量评定方法

按照确定的火炸药生产质量评定指标体系,通过确定评定指标的含义及统计计算方法,实现底层指标的统计计算．然后采用极大和极小型效用函数将底层指标统计值转换成极大型指标评定值,运用层次分析法确定主观权重．再综合确定指标体系的权重。根据评定目标,运用加权综合法确定定量评定数学模型,进行综合评定和分目标评定．通过产品分级,查找薄弱环节,实现火炸药产品生产质量定量评定。     

发制品加工废水处理工艺的试验研究

对水解酸化-生物接触氧化-化学氧化-活性炭吸附工艺在发制品加工废水处理中的应用进行了试验研究,确定了生物处理和化学处理的参数,并对各水处理单元的处理效果做了详细的分析.试验结果表明,CODCr、BOD5、SS、NH3-N、色度的总去除率分别达到92.1%、92.8%、82.2%、94.5%、96.9%,出水水质可以达到国家二级排放标准.对发制品行业废水的治理有一定的借鉴意义.     

Electrochemical assessment of the restoration and conservation of a heavily corroded archaeological iron artifact

This study proposes an electrochemical conservation routine applicable to iron archaeological artifacts extracted from their archaeological context and later exposed to a marine atmosphere. The case of study consisted of a Nineteenth Century anchor safeguarded in the Mexican City of Campeche. Metallurgical characterization and electrochemical studies were used to evaluate and assess the conservation process (electrochemical free chloride removal and species reduction, passivation and coating treatment evaluation) and to quantify their effectiveness. Additionally, archaeological information regarding the manufacture process was obtained. The techniques used include potential measurement, potentiodynamic polarization (polarization curves), potentiostatic measurements, electrochemical impedance spectroscopy, electrochemical noise measurements, as well as metallography studies. The method here proposed can then be used in analogous set up as a guideline example for evaluation and assessment purposes during similar procedures.     

长链α-烯烃的生产与应用前景

简要地阐述了国内外长链α 烯烃的生产现状及国内市场情况 ,并根据我国国情 ,提出了蜡裂解制取长链α 烯烃的工艺路线。并以 5 4 # 半炼蜡为原料进行蜡裂解试验 ,通过精密分馏将目的烯烃切割成不同馏分 ,进行下游产品的评定试验。试验结果表明 ,以半炼蜡为原料 ,通过裂解工艺 ,可以生产出质量合格的符合下游产品应用要求的长链α 烯烃产品 ,解决了国内部分行业的急需 ,具有很好的社会效益和经济效益     

Extractables and leachables issues with the application of single use technology in the biopharmaceutical industry

Single‐use technology has been adopted widely in bioprocess development and biopharmaceutical manufacture in recent years. While the benefits of such technologies are well recognized, there are significant concerns regarding extractables and leachables arising from the components of single‐use systems owing to their potential effect on product quality and patient health. Their impact on drug product quality and safety must be clearly understood before adopting disposable technologies into manufacture. A risk assessment is normally required to assess the probability of extractables and leachables migrating into the product stream and their potential risk to the patient. Generic information provided by suppliers may be useful but its relevance to individual applications needs to be demonstrated. Standardization of extractables and leachables testing and approaches to risk assessment has been discussed between the biopharmaceutical industry and regulators. This perspective reviews the current status of extractables and leachables studies within the biopharmaceutical industry and the general approaches employed for risk evaluation associated with the application of single‐use technology. © 2015 Society of Chemical Industry     

Bewertung von Abfallbehandlungsverfahren: Entscheidungsunterstützung durch die neue VDI‐Richtline 3925

The new VDI guideline 3925 presents assessment tools for the comparison of economic, ecological and also social aspects of different waste treatment processes. Objective of the guideline is to describe the application of suitable scientific and technical assessment methods to waste management strategies. The methods, their applicability, complexity, opportunities and limits are illustrated using practical examples.