Animal testing for vaccines. Implementing replacement, reduction and refinement: challenges and priorities

被引：34

作者：

Akkermans, Arnoud ^{[1
]}

Chapsal, Jean-Michel ^{[2
]}

Coccia, Eliana M. ^{[3
]}

Depraetere, Hilde ^{[4
]}

Dierick, Jean-Francois ^{[5
]}

Duangkhae, Parichat ^{[6
]}

Goel, Sunil ^{[7
]}

Halder, Marlies ^{[8
]}

Hendriksen, Coenraad ^{[9
]}

Levis, Robin ^{[10
]}

Pinyosukhee, Koraphong ^{[11
]}

Pullirsch, Dieter ^{[12
]}

Sanyal, Gautam ^{[13
]}

Shi, Li ^{[14
]}

Sitrin, Robert ^{[15
]}

Smith, Dean ^{[16
]}

Stickings, Paul ^{[17
]}

Terao, Eriko ^{[18
]}

Uhlrich, Sylvie ^{[19
]}

Viviani, Laura ^{[20
]}

Webster, Jim ^{[21
]}

机构：

[1] Natl Inst Publ Hlth & Environm RIVM, Utrecht, Netherlands

[2] European Partnership Alternatives Anim Testing EP, Nice, France

[3] Ist Super Sanita, Rome, Italy

[4] European Vaccine Initiat EVI, Heidelberg, Germany

[5] GSK, Wavre, Belgium

[6] Govt Pharmaceut Org, Bangkok, Thailand

[7] Serum Inst India Pvt Ltd, Pune, Maharashtra, India

[8] European Commiss, Joint Res Ctr JRC, Ispra, Italy

[9] Intravacc, Bilthoven, Netherlands

[10] US FDA, CBER, Silver Spring, MD USA

[11] Minist Publ Hlth, Nonthaburi, Thailand

[12] Austrian Agcy Hlth & Food Safety Ages, Vienna, Austria

[13] Vaccine Analyt LLC, Princeton, NJ USA

[14] Shanghai Zerun Biotechnol Co, Shanghai, Peoples R China

[15] PATH, Seattle, WA USA

[16] Hlth Canada, Ottawa, ON, Canada

[17] Natl Inst Biol Stand & Control NIBSC, Ridge, Herts, England

[18] European Directorate Qual Med & Healthcare EDQM, Strasbourg, France

[19] Sanofi Pasteur, Lyon, France

[20] Humane Soc Int, Basel, Switzerland

[21] World Org Anim Hlth OIE, Hamilton, New Zealand

来源：

BIOLOGICALS | 2020年 / 68卷

基金：

比尔及梅琳达.盖茨基金会;

关键词：

Replace; Reduce; Refine; Alternative methods to animal testing; Vaccine; Regulatory harmonization; ABNORMAL TOXICITY TEST; ALTERNATIVE METHODS; QUALITY-CONTROL; POTENCY; WORKSHOP; SCIENCE; RECOMMENDATIONS; VALIDATION; STATE;

D O I：

10.1016/j.biologicals.2020.07.010

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Transition to in vitro alternative methods from in vivo in vaccine release testing and characterization, the implementation of the consistency approach, and a drive towards international harmonization of regulatory requirements are most pressing needs in the field of vaccines. It is critical for global vaccine community to work together to secure effective progress towards animal welfare and to ensure that vaccines of ever higher quality can reach the populations in need in the shortest possible timeframe. Advancements in the field, case studies, and experiences from Low and Middle Income Countries (LMIC) were the topics discussed by an international gathering of experts during a recent conference titled "Animal Testing for Vaccines - Implementing Replacement, Reduction and Refinement: Challenges and Priorities". This conference was organized by the International Alliance for Biological Standardization (IABS), and held in Bangkok, Thailand on December 3 and 4 2019. Participants comprised stakeholders from many parts of the world, including vaccine developers, manufacturers and regulators from Asia, Europe, North America, Australia and New Zealand. In interactive workshops and vibrant panel discussions, the attendees worked together to identify the remaining barriers to validation, acceptance and implementation of alternative methods, and how harmonization could be promoted, especially for LMICs.

引用

页码：92 / 107

页数：16

共 30 条

[1]

AGAATI, 2002, BIOLOGICALS, V30, P277

[2]

[Anonymous], 2019, MONOGRAPH, P1375

[3]

[Anonymous], 2016, Insight

[4]

[Anonymous], 1999, VAL AN PROC METH VAL

[5]

[Anonymous], 1997, 889 WHO TRS

[6]

[Anonymous], 2018, Indian pharmacopoeia

[7] Drivers and barriers in the consistency approach for vaccine batch release testing: Report of an international workshop [J].

Bruysters, Martijn W. P. ;

Schiffelers, Marie-Jeanne ;

Hoonakker, Marieke ;

Jungbaeck, Carmen ;

Ragan, Ian ;

Rommel, Eddy ;

van der Stappen, Ton ;

Viviani, Laura ;

Hessel, Ellen V. ;

Akkermans, Arnoud M. ;

Vandebriel, Rob J. .

BIOLOGICALS, 2017, 48 :1-5

[8]

De Mattia Fabrizio, 2011, Biologicals, V39, P59, DOI 10.1016/j.biologicals.2010.12.001

[9] A case study of development, validation, and acceptance of a non-animal method for assessing human vaccine potency [J].

Descamps, Johan ;

Giffroy, Didier ;

Remy, Eric ;

Mortiaux, Frederic ;

Mareschal, Jean-Claude ;

Ponsar, Cecile ;

Duchene, Michel .

INTERNATIONAL WORKSHOP ON ALTERNATIVE METHODS TO REDUCE, REFINE, AND REPLACE THE USE OF ANIMALS IN VACCINE POTENCY AND SAFETY TESTING: STATE OF THE SCIENCE AND FUTURE DIRECTIONS, 2011, 5 :184-191

[10] Optimization of the Monocyte Activation Test for Evaluating Pyrogenicity of Tick-Borne Encephalitis Virus Vaccine [J].

Etna, Marilena P. ;

Giacomini, Elena ;

Rizzo, Fabiana ;

Severa, Martina ;

Ricci, Daniela ;

Shaid, Shahjahan ;

Lambrigts, Denis ;

Valentini, Sara ;

Stampino, Luisa Galli ;

Alleri, Liliana ;

Gaggioli, Andrea ;

von Hunolstein, Christina ;

Spreitzer, Ingo ;

Coccia, Eliana M. .

ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION, 2020, 37 (04) :532-544

← 1 2 3 →