Support for the revocation of general safety test regulations in biologics license applications.
作者： Dana M. Evans , Jennifer M. Thorn , Katherine Arch-Douglas , Justin B. Sperry , Bruce Thompson
DOI: 10.1016/J.BIOLOGICALS.2016.02.001
关键词:
摘要: The United States Food and Drug Administration recently removed the requirement for a General Safety Test (GST) biologics in Code of Federal Regulations (21 CFR 610.11). GST, as well abnormal toxicity (European Pharmacopeia) innocuity tests (World Health Organization), were designed to test extraneous toxic contaminants on each product lot intended human use. Tests require one-week observations general health weight following injection specified volumes batches into guinea pigs mice. At specified, dose-related may result when is pharmacologically active rodents. With vaccines, required doses be > 3 logs higher than dose weight-adjusted basis if an immune modulatory adjuvant included, systemic hyperactivation cause toxicity. Herein, using CpG/alum combination we evaluated different protocols showed their unsuitability this combination.
sci-hub.se 参考文章(18)
Martin Gilar, Kenneth J. Fountain, Yeva Budman, Uwe D. Neue, Kurt R. Yardley, Paul D. Rainville, Reb J. Russell II, John C. Gebler, Ion-pair reversed-phase high-performance liquid chromatography analysis of oligonucleotides: retention prediction. Journal of Chromatography A. ,vol. 958, pp. 167- 182 ,(2002) , 10.1016/S0021-9673(02)00306-0
Burnouf T, Padilla A, van Aken Wg, McIntosh R, Horowitz B, Morgenthaler Jj, Minor P, Thorpe R, WHO Expert Committee on Biological Standardization. World Health Organization technical report series. ,vol. 924, pp. 1- ,(2004)
WAYNE M. GALBRAITH, WILLIAM C. HOBSON, PATRICIA C. GICLAS, PAUL J. SCHECHTER, SUDHIR AGRAWAL, Complement activation and hemodynamic changes following intravenous administration of phosphorothioate oligonucleotides in the monkey. Antisense research and development. ,vol. 4, pp. 201- 206 ,(1994) , 10.1089/ARD.1994.4.201
Scott A. Halperin, Brian Ward, Curtis Cooper, Gerald Predy, Francisco Diaz-Mitoma, Marc Dionne, Joanne Embree, Allison McGeer, Paul Zickler, Karl-Heinz Moltz, René Martz, Ingo Meyer, Shelly McNeil, Joanne M. Langley, Eduardo Martins, William L. Heyward, J. Tyler Martin, Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adults 18–55 years of age Vaccine. ,vol. 30, pp. 2556- 2563 ,(2012) , 10.1016/J.VACCINE.2012.01.087
Alex Apffel, John A. Chakel, Steven Fischer, Kay Lichtenwalter, William S. Hancock, Analysis of Oligonucleotides by HPLC-Electrospray Ionization Mass Spectrometry. Analytical Chemistry. ,vol. 69, pp. 1320- 1325 ,(1997) , 10.1021/AC960916H
Achim H. Krotz, Rahul C. Mehta, Gregory E. Hardee, Peroxide-mediated desulfurization of phosphorothioate oligonucleotides and its prevention. Journal of Pharmaceutical Sciences. ,vol. 94, pp. 341- 352 ,(2005) , 10.1002/JPS.20235
Takuo Mizukami, Atsuko Masumi, Haruka Momose, Madoka Kuramitsu, Kazuya Takizawa, Seishiro Naito, Jun-ichi Maeyama, Keiko Furuhata, Momoka Tsuruhara, Isao Hamaguchi, Kazunari Yamaguchi, An improved abnormal toxicity test by using reference vaccine-specific body weight curves and histopathological data for monitoring vaccine quality and safety in Japan Biologicals. ,vol. 37, pp. 8- 17 ,(2009) , 10.1016/J.BIOLOGICALS.2008.07.007
Joerg H.O. Garbe, Susanne Ausborn, Claire Beggs, Martin Bopst, Angelika Joos, Alexandra A. Kitashova, Olga Kovbasenco, Claus-Dieter Schiller, Martina Schwinger, Natalia Semenova, Lilia Smirnova, Fraser Stodart, Thomas Visalli, Lisette Vromans, Historical Data Analyses and Scientific Knowledge Suggest Complete Removal of the Abnormal Toxicity Test as a Quality Control Test Journal of Pharmaceutical Sciences. ,vol. 103, pp. 3349- 3355 ,(2014) , 10.1002/JPS.24125
Michael J. McCluskie, Jennifer Thorn, Paul R. Mehelic, Parag Kolhe, Keshab Bhattacharya, Jari I. Finneman, David R. Stead, Michele Bailey Piatchek, Ningli Zhang, Ghania Chikh, Janna Cartier, Dana M. Evans, James R. Merson, Heather L. Davis, Molecular attributes of conjugate antigen influence function of antibodies induced by anti-nicotine vaccine in mice and non-human primates. International Immunopharmacology. ,vol. 25, pp. 518- 527 ,(2015) , 10.1016/J.INTIMP.2015.02.030
Robert J. Hopkins, Nancy F. Daczkowski, Paulina E. Kaptur, Derek Muse, Eric Sheldon, Craig LaForce, Suha Sari, Thomas L. Rudge, Edward Bernton, Randomized, double-blind, placebo-controlled, safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers Vaccine. ,vol. 31, pp. 3051- 3058 ,(2013) , 10.1016/J.VACCINE.2013.04.063