Developments in biologicals最新文献_第3页

Vaccination for the control of Rift Valley fever in enzootic and epizootic situations. 在地方性和兽疫情况下控制裂谷热的疫苗接种。

Developments in biologicals Pub Date : 2013-01-01 Epub Date: 2013-05-14 DOI: 10.1159/000157178

B Dungu, M Donadeu, M Bouloy

引用次数: 14

Potency testing of veterinary rabies vaccines: replacement of challenge by in vitro testing: considerations for development of alternative assays. 兽用狂犬病疫苗的效力试验:用体外试验替代攻毒:发展替代测定法的考虑

Developments in biologicals Pub Date : 2012-01-01

C E Lewis, A M Fry, J R Hermann, D Siev, D M Dusek, D M Gatewood

引用次数: 0

The quantitative ELISA for inactivated Newcastle disease virus antigen: development of the test system and the way to a Ph. Eur in vitro potency test. 新城疫病毒灭活抗原定量ELISA检测系统的建立及Ph. Eur体外效价检测方法。

Developments in biologicals Pub Date : 2012-01-01

H L Oei

引用次数: 0

In vitro vaccine potency testing: a proposal for reducing animal use for requalification testing. 体外疫苗效力试验:减少动物用于再鉴定试验的建议。

Developments in biologicals Pub Date : 2012-01-01

K Brown, W Stokes

{"title":"In vitro vaccine potency testing: a proposal for reducing animal use for requalification testing.","authors":"K Brown, W Stokes","doi":"","DOIUrl":"","url":null,"abstract":"This paper proposes a program under which the use of animals for requalification of in vitro potency tests could be eliminated. Standard References (USDA/CVB nomenclature) would be developed, characterized, stored and monitored by selected reference laboratories worldwide. These laboratories would employ scientists skilled in protein and glycoprotein chemistry and equipped with state-of-the-art instruments for required analyses. After Standard References are established, the reference laboratories would provide them to the animal health industry as \"gold standards\". Companies would then establish and validate a correlation between the Standard Reference and the company Master Reference (USDA/CVB nomenclature) using an internal in vitro assay. After this correlation is established, the company could use the Standard References for qualifying, monitoring and requalifying company Master References without the use of animals. Such a program would eliminate the need for animals for requalification of Master References and the need for each company to develop and validate a battery of Master Reference Monitoring assays. It would also provide advantages in terms of reduced costs and reduced time for requalification testing. As such it would provide a strong incentive for companies to develop and use in vitro assays for potency testing.","PeriodicalId":11190,"journal":{"name":"Developments in biologicals","volume":"134 ","pages":"75-81"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30831309","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}

引用次数: 0

AlphaLISA assays to improve the vaccine development process. AlphaLISA检测改善疫苗开发过程。

Developments in biologicals Pub Date : 2012-01-01

G Cosentino

引用次数: 0

Potential application of the consistency approach for vaccine potency testing. 一致性方法在疫苗效力检测中的潜在应用。

Developments in biologicals Pub Date : 2012-01-01

J Arciniega, L A Sirota

{"title":"Potential application of the consistency approach for vaccine potency testing.","authors":"J Arciniega, L A Sirota","doi":"","DOIUrl":"","url":null,"abstract":"The Consistency Approach offers the possibility of reducing the number of animals used for a potency test. However, it is critical to assess the effect that such reduction may have on assay performance. Consistency of production, sometimes referred to as consistency of manufacture or manufacturing, is an old concept implicit in regulation, which aims to ensure the uninterrupted release of safe and effective products. Consistency of manufacture can be described in terms of process capability, or the ability of a process to produce output within specification limits. For example, the standard method for potency testing of inactivated rabies vaccines is a multiple-dilution vaccination challenge test in mice that gives a quantitative, although highly variable estimate. On the other hand, a single-dilution test that does not give a quantitative estimate, but rather shows if the vaccine meets the specification has been proposed. This simplified test can lead to a considerable reduction in the number of animals used. However, traditional indices of process capability assume that the output population (potency values) is normally distributed, which clearly is not the case for the simplified approach. Appropriate computation of capability indices for the latter case will require special statistical considerations.","PeriodicalId":11190,"journal":{"name":"Developments in biologicals","volume":"134 ","pages":"135-9"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30831317","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}

引用次数: 0

Appropriateness of in vitro potency tests as a measure of vaccine or reference stability. 体外效力试验作为衡量疫苗或参比稳定性的适当性。

Developments in biologicals Pub Date : 2012-01-01

M-A Pfannenstiel, M Inman

引用次数: 0

Towards in vitro potency testing of inactivated erysipelas vaccines. 丹毒灭活疫苗体外效价测定的探讨。

Developments in biologicals Pub Date : 2012-01-01

E Balks, C Wolf, H Loessner, E Werner

引用次数: 0

The validation of potency tests: hurdles identified by EMA/CVMP/IWP. 效价试验的验证:EMA/CVMP/IWP确定的障碍。

Developments in biologicals Pub Date : 2012-01-01

R Woodland

引用次数: 0

In vitro antigen measurement and potency tests: challenges encountered during method development...and lessons learned. 体外抗原测定和效价试验:方法开发过程中遇到的挑战…并从中吸取教训。

Developments in biologicals Pub Date : 2012-01-01

V Kubiak

{"title":"In vitro antigen measurement and potency tests: challenges encountered during method development...and lessons learned.","authors":"V Kubiak","doi":"","DOIUrl":"","url":null,"abstract":"Despite significant investment and technical efforts, veterinary vaccine manufacturers continue to experience challenges with the transition from historic animal-based potency methods to in vitro potency assays. These challenges have a number of contributing factors, including an inadequate understanding of protective antigens and epitopes, a lack of ruggedness and discriminating capabilities in evolving immunologically-based methods, inconsistencies between methods used for in-process antigen measurement and finished product potency, and a lack of clear methods to characterize the finished formulation (including complex adjuvants). A lack of harmonized guidelines and consistent regulatory expectations further complicates these efforts. There is room for optimism, however. There are numerous examples of successful in vitro potency test implementations. Titrations of modified live viral and bacterial vaccines, immune-based quantitative assays, and the recent application of direct physicochemical methods have allowed the transition from animal testing in many applications globally. Specific challenges for assay development and implementation are discussed in the areas of 1) target antigen selection, 2) complexity of finished product formulation, 3) potency discrimination, and 4) stability-indicating relevance.","PeriodicalId":11190,"journal":{"name":"Developments in biologicals","volume":"134 ","pages":"83-91"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30831310","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}

引用次数: 0