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Replacement of in vivo human rabies vaccine potency testing by in vitro glycoprotein quantification using ELISA - Results of an international collaborative study.

Autor: Morgeaux S; Agence Nationale de Sécurité du Médicament et des Produits de Santé, Laboratory Controls Division, Batch Release and Marketing Surveillance of Biological Products Department, 312 Avenue Jean Jaurès, F-69007 Lyon, France., Poirier B; Independent Statistical Expert, 207 L'Ove, 69700 Chassagny, France., Ragan CI; European Partnership for Alternative Approaches to Animal Testing, Brussels, Belgium. Electronic address: ian.ragan1@btinternet.com., Wilkinson D; Division of Virology, National Institute for Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK., Arabin U; GSK Vaccines GmbH, Emil-von-Behring-Straβe 76, 35041 Marburg, Germany., Guinet-Morlot F; Sanofi-Pasteur, 1541 av. Marcel Mérieux, 69280 Marcy L'Etoile, France., Levis R; Center for Biologics Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Meyer H; Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Str. 51-59, 63225 Langen, Germany., Riou P; Sanofi-Pasteur, 1541 av. Marcel Mérieux, 69280 Marcy L'Etoile, France., Shaid S; GSK Vaccines GmbH, Emil-von-Behring-Straβe 76, 35041 Marburg, Germany., Volokhov D; Center for Biologics Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Tordo N; Unité Stratégies Antivirales, Institut Pasteur, 25 rue du Dr. Roux, 75724 Paris Cedex 15, France; Institut Pasteur de Guinée, Conakry, Guinea., Chapsal JM; Independent Expert, 195 Traverse des Verdelières, 69380 Charnay, France.

Publikováno v: Vaccine [Vaccine] 2017 Feb 07; Vol. 35 (6), pp. 966-971. Date of Electronic Publication: 2017 Jan 09.

Alternatives to HIST for acellular pertussis vaccines: progress and challenges in replacement.

Autor: Arciniega J; US FDA., Wagner L; US FDA., Prymula R; UH., Sebo P; ASCR., Isbrucker R; Health Canada., Descampe B; GSK., Chapsal JM; Sanofi Pasteur., Costanzo A; EDQM., Hendriksen C; IntraVacc., Hoonaker M; IntraVacc., Nelson S; Sanofi Pasteur., Lidster K; NC3Rs., Casey W; NIEHS., Allen D; ILS.

Publikováno v: Pharmeuropa bio & scientific notes [Pharmeur Bio Sci Notes] 2016; Vol. 2015, pp. 82-96.

Report on the international workshop on alternatives to the murine histamine sensitization test (HIST) for acellular pertussis vaccines: state of the science and the path forward.

Autor: Isbrucker R; Health Canada, Biologics and Genetic Therapies Directorate, 100 Eglantine Drive, Ottawa, Ontario K1A 0K9, Canada. Electronic address: richard.isbrucker@hc-sc.gc.ca., Arciniega J; United States Food and Drug Administration Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852, USA., McFarland R; United States Food and Drug Administration Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852, USA., Chapsal JM; Sanofi Pasteur, Lyon, France., Xing D; Division of Bacteriology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Hertfordshire EN6 3QG, UK., Bache C; Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany., Nelson S; Sanofi Pasteur, Toronto, Ontario, Canada., Costanzo A; European Directorate for the Quality of Medicines and Healthcare, Strasbourg, France., Hoonakker M; Netherlands Vaccine Institute, Antonie van Leeuwenhoeklaan 9-11, 3721MA Bilthoven, The Netherlands., Castiaux A; GlaxoSmithKline, Rue de l'Institut 89, 1330 Rixensart, Belgium., Halder M; European Commission Joint Research Centre, Institute for Health and Consumer Protection, The European Union Reference Laboratory for Alternatives to Animal Testing, Via E. Fermi 2749, TP 580, 21027 Ispra, Varese, Italy., Casey W; National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health, P.O. Box 12233, MD: K2-16, Research Triangle Park, NC 27709, USA., Johnson N; Integrated Laboratory Systems Inc., 630 Davis Drive, Suite 160, Morrisville, NC 27560, USA., Jones B; Integrated Laboratory Systems Inc., 630 Davis Drive, Suite 160, Morrisville, NC 27560, USA., Doelling V; Integrated Laboratory Systems Inc., 630 Davis Drive, Suite 160, Morrisville, NC 27560, USA., Sprankle C; Integrated Laboratory Systems Inc., 630 Davis Drive, Suite 160, Morrisville, NC 27560, USA., Rinckel L; Integrated Laboratory Systems Inc., 630 Davis Drive, Suite 160, Morrisville, NC 27560, USA., Stokes W; National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, Division of the National Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of Health, P.O. Box 12233, MD: K2-16, Research Triangle Park, NC 27709, USA.

Publikováno v: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2014 Mar; Vol. 42 (2), pp. 114-22. Date of Electronic Publication: 2014 Jan 04.

The consistency approach for quality control of vaccines - a strategy to improve quality control and implement 3Rs.

Autor: De Mattia F; Intervet/Schering-Plough Animal Health, PO Box 31, 5830 AA Boxmeer, The Netherlands. Fabrizio.de.mattia@spcorp.com, Chapsal JM, Descamps J, Halder M, Jarrett N, Kross I, Mortiaux F, Ponsar C, Redhead K, McKelvie J, Hendriksen C

Publikováno v: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2011 Jan; Vol. 39 (1), pp. 59-65. Date of Electronic Publication: 2011 Jan 31.