Developments in biological standardization最新文献_第6页

Development and standardisation of DNA vaccines. DNA疫苗的开发和标准化。

Developments in biological standardization Pub Date : 1999-01-01

K Cichutek

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Regulation of biologicals in China. 中国对生物制品的监管。

Developments in biological standardization Pub Date : 1999-01-01

H Zhou

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Viral validation design of a manufacturing process. 制造过程的病毒验证设计。

Developments in biological standardization Pub Date : 1999-01-01

D Larzul

{"title":"Viral validation design of a manufacturing process.","authors":"D Larzul","doi":"","DOIUrl":"","url":null,"abstract":"In many cases, the viral safety evaluation of biological products does not derive solely from direct testing for the presence of contaminants, but also from the demonstration that the manufacturing process is able to inactivate/eliminate them. This is achieved by the voluntary addition of a virus load at various steps of the process and the evaluation of viral reduction during the subsequent steps. The major difficulty for such viral validation studies is less to calculate a reduction factor for each step than to identify clearly and demonstrate the contribution of each in-process parameter to the reduction. Consequently, the first approach consists of the identification of all the parameter which may influence viral reduction. The design of the viral validation needs to take this inventory into account and control experiments must be carried out in parallel with the main spiking experiment, i.e. mainly to: (i) hold controls with and without the biological intermediate product; (ii) control experiments with each individual inactivating/partitioning parameter; (iii) control experiment without stabilizer if necessary. In addition to these process controls, cytotoxicity and interference experiments will allow the use of each in vitro infectivity assay for the testing of processed samples to be validated. For a viral inactivation step, the kinetics of inactivation will be studied and the data will show: (i) a progressive decrease of the viral load over time. If the decrease is too rapid to plot the kinetics, the direct relation between the inactivation and the inactivating parameter has to be demonstrated in complementary experiments; (ii) the reduction obtained when in-process limits are used and (iii) the different phases of inactivation when they exist. Moreover, it is pertinent to evaluate for each treatment the margin of safety derived from the treatment time on the one hand and the strength of the inactivating parameter on the other.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"99 ","pages":"139-50"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21271089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Safety issues of animal products used in serum-free media. 无血清培养基中使用的动物产品的安全问题。

Developments in biological standardization Pub Date : 1999-01-01

O W Merten

{"title":"Safety issues of animal products used in serum-free media.","authors":"O W Merten","doi":"","DOIUrl":"","url":null,"abstract":"The development of media free of serum and animal or human protein is of utmost importance for increasing the safety of biologicals produced for therapy and vaccination. The main drawback associated with the use of serum or animal-derived substances for animal cell technology is the potential introduction of contaminants (adventitious agents) into the process and thus potentially into the final product. This fact led to an increased effort to replace serum-containing with serum-free media. In most cases, these media are supplemented with purified proteins, peptones, or hydrolysates, mainly of animal or human origin. Although such serum-free media are more defined than serum-containing media, the risk of the introduction of viruses by using animal-derived substances is still present, signifying that only a complete replacement of animal-derived substances by non-animal-derived products leads to a relatively safe serum-free medium. The potential replacement of these animal/human-derived substances by those of non-animal origin (e.g. plant origin) will be discussed. In several examples, the potential of serum-free media free of any animal-derived component in supporting cell growth and production of biologicals will be presented. In this context, the risk of using non-animal-derived substances in serum-free media for animal cell technology will be discussed with respect to classically used cell culture media.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"99 ","pages":"167-80"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21271092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Bioassays for growth factors. 生长因子的生物测定。

Developments in biological standardization Pub Date : 1999-01-01

C J Robinson

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Spectroscopic characterization of chemokines: relevance for quality control and standardization. 趋化因子的光谱表征:与质量控制和标准化相关。

Developments in biological standardization Pub Date : 1999-01-01

K Rajarathnam, M P Crump, I Clark-Lewis, B D Sykes

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The role of the bioassay in the evaluation of cytokines and growth factors for regulatory decision making. 生物测定法在细胞因子和生长因子评估中的作用，为监管决策提供依据。

Developments in biological standardization Pub Date : 1999-01-01

D S Finbloom

引用次数: 0

Validation of bioassays for quality control. 用于质量控制的生物测定法的验证。

Developments in biological standardization Pub Date : 1999-01-01

D Lansky

{"title":"Validation of bioassays for quality control.","authors":"D Lansky","doi":"","DOIUrl":"","url":null,"abstract":"For a biological assay to be useful for quality control it should fail bad lots, pass good lots, and estimate relative potency with high accuracy and precision. To fail a lot we rely most heavily on the test for parallelism. For the parallelism test and other preliminary tests as well as for inference, appropriate estimates of assay variation are crucial. Location effects on 96 well plates and serial dilution of samples using multichannel pipettes make it difficult to obtain good estimates of assay variation. This paper develops the use of a split-block design and analysis where blocks are reasonably consistent regions of a plate; this approach removes some location effects, allows other location effects to be treated as assay variation and provides appropriate measures of assay variation. Randomization, even within the split-block design, is difficult without robots to reduce the likelihood of procedural errors. There are hardware, software, and validation obstacles to implementation of robots in the bioassay laboratory. More generally, validation of a bioassay should be reported on log relative potency and must address between- and within-assay variation. When between assay variation is not small, the usual weighted approach to combining relative potency estimates (which ignores between-assay variation) is inappropriate; a simple sampling average and standard deviation is a better solution.","PeriodicalId":11308,"journal":{"name":"Developments in biological standardization","volume":"97 ","pages":"157-68"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21327703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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Difficulties in standardizing the neuraminidase content of influenza vaccines. 流感疫苗神经氨酸酶含量标准化的难点。

Developments in biological standardization Pub Date : 1999-01-01

L Gérentes, N Kessler, M Aymard

引用次数: 0

Inactivated influenza vaccines prepared in cell culture. Summary and recommendations. 细胞培养制备的灭活流感疫苗。总结和建议。

Developments in biological standardization Pub Date : 1999-01-01

P D Minor

引用次数: 0