BIOLOGICALS

作者Elliot Lilley; Sunil Goel; Robin Levis; Shajahan Shaid; Sarah Sheridan; Paul Stickings; Laura Viviani; Anthony Holmes

作者单位NC3Rs, London, United Kingdom; Serum Institute of India, India; Food and Drug Administration, USA; GlaxoSmithKline, Germany; Merck, Glasgow, United Kingdom; Medicines and Healthcare Products Regulatory Agency, United Kingdom; SciEthiq, Italy

作者Laura Viviani; Evelin Balbino; Meenu Batolar; Jay Bolden; Sarawut Boonsuk; Badiaa Bouzya; Mihaela Buda; Jean-Michel Chapsal; Emmanuelle Coppens; Pradip Das; Fitra Delviona; Blaise Descampe; Alan Fauconnier; Sunil Goel; Juliana Gutierrez-Mazariegos; Bernhard Illes; Masaaki Iwaki; Muthusamy Kalaivani; Naree Ketusing; Manjari Lal; Dianliang Lei; Joe Little; Kutub Mahmood; Javier Martin; Laure Martinez; Catherine Milne; Mercy Mvundura; Ole F. Olesen; Katarzyna Osetek-Müller; Lorenzo Del Pace; Sampa Pal; In-Sook Park; Corinne Philippe; Colleen Pike; Luca Porfiri; Nakorn Premsri; Dieter Pullirsch; Charles Sandy; Gautam Sanyal; Kota Sato; Heidemarie Schindl; Sarah Sheridan; Juliana Galvão; Rabindra Prasad Singh; Dean Smith; Paul Stickings; Danilo Tagle; Lorenzo Tesolin; Joris Vandeputte; Janette Turner

作者单位SciEthiQ, Italy; ANVISA, Brazil; CEPI, Singapore; Eli Lilly & Company, USA; Department of Medical Sciences, Ministry of Public Health, Thailand; GSK, Belgium; EDQM, France; Consultant & EDQM Project Manager BSP148, France; Sanofi, France; Biological E, India; BADAN POM, Indonesia; Humane World for Animals, Belgium; WHO, Switzerland; Serum Institute of India Pvt Ltd, India; BioMérieux, Japan; Microcoat, Germany; Japan Institute for Health Security (JIHS), Japan; Indian Pharmacopeia Commission, India; WOAH, Thailand; PATH, USA; MHRA, UK; Virbac, France; European Vaccine Initiative (EVI), Germany; Bavarian Nordic, Germany; Humane World for Animals, Italy; Korea Regulatory Science Centre, South Korea; Boehringer Ingelheim, France; Humane World for Animals, USA; FAO, Thailand; National Vaccine Institute of Thailand, Thailand; AGES, Austria; AUDA-NEPAD, South Africa; Vaccine Analytics, USA; National Veterinary Assay Laboratory, Japan; Merck, UK; Fundação Butantan, Brazil; ICAR-National Institute on Foot and Mouth Disease, India; IABS, Canada; NIH, USA; Sciensano, Belgium; IABS, Switzerland; Humane World for Animals, UK

作者Charton E; Hornik A; Schütte K; Bouzya B; Spreitzer I; Coppens E; Stirling C; Baay M; Viviani L; Manou I

作者单位European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, Strasbourg, France; European Commission, Brussels, Belgium; GSK Vaccines, Wavre, Belgium; Paul-Ehrlich-Institute PEI, Langen, Germany; Sanofi Vaccines, Marcy-l'Étoile, France; Zoetis, Leatherhead, United Kingdom; AnimalHealthEurope, Brussels, Belgium; P95 Clinical & Epidemiology Services, Leuven, Belgium; SciEthiQ, Sarnico, Italy; European Partnership for Alternative Approaches to Animal Testing (EPAA), Brussels, Belgium

作者Ashwani Kumar Mandyal; Rajasekaran Angannan; Balananda Dhurjati Kumar Putcha; Charles David; Tarun Sharma

作者单位Department of Biotechnology, Vignan's Foundation for Science, Technology and Research, Vadlamudi, Guntur District, Andhra Pradesh, 522213, India; R&D Department, Auro Vaccines Private Limited, Indrakaran, Sangareddy District, Hyderabad, Telangana, 502329, India

作者Michikazu Tanio; Isao Hamaguchi; Takuo Mizukami

作者单位Center for Next-Generation Biologics Research, National Institute of Infectious Diseases, Japan Institute for Health Security, Gakuen 4-7-1, Musashimurayama-city, Tokyo, 208-0011, Japan; Department of Clinical Laboratory, Subaru Health Insurance Society Ota Memorial Hospital, Gunma, Japan

作者Sonam Rastogi; Alka Shukla; Mayank Gangwar; Sudhir Kumar Singh; Manoj Kumar; Deepak Kumar; Vandana Rastogi; Chanda Hemaliya; Gopal Nath

作者单位Virus Research and Diagnostic Laboratory, Department of Microbiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India; Department of Microbiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India; Clinical Studies and Trial Unit, Division of Development Research, Indian Council of Medical Research, New Delhi, India; Department of Statistics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India; Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India

作者Minghua Zheng; Huanhuan Cao; Yuetong Li; Yue Liu; Yuexin Wang; Yuyun Zhang; Daning Wang; Lizhi Zhou; Wenhui Xue; Zhibo Kong; Qingbin Zheng; Hai Yu; Ningshao Xia; Ying Gu; Shaowei Li

作者单位State Key Laboratory of Vaccines for Infectious Diseases, Xiang an Biomedicine Laboratory, School of Public Health, School of Life Sciences, Xiamen University, Xiamen, 361102, China; National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, Collaborative Innovation Center of Biologic Products, National Innovation Platform for Industry-Education Integration in Vaccine Research, The Research Unit of Frontier Technology of Structural Vaccinology of Chinese Academy of Medical Sciences, Xiamen University, Xiamen, 361102, China; Xiamen Innovax Biotech, Xiamen, Fujian, 361000, China

作者Victor Cnossen; Annefleur Hensen; Laura Pattacini; Pepijn Al; Anna Durbin; Pedro Folegatti; Rieke van der Graaf; Simon Kolstoe; Ricardo Palacios; Seema K. Shah; Meta Roestenberg; Nicola Viebig; Martine de Vries; Marc Baay; Joris Vandeputte; Pieter Neels; Ingrid M.C. Kamerling; Marie-Astrid Hoogerwerf

作者单位Centre for Human Drug Research (CHDR), Leiden, the Netherlands; Leiden University Medical Centre (LUMC), Leiden, the Netherlands; University Medical Centre Utrecht (UMCU), Utrecht, the Netherlands; Central Committee on Research Involving Human Subjects (CCMO), The Hague, the Netherlands; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Sanofi, Marcy-l'Étoile, France; University of Portsmouth, Portsmouth, UK; GSK, Siena, Italy; Northwestern Feinberg School of Medicine, Chicago, IL, USA; European Vaccine Initiative (EVI), Heidelberg, Germany; P95 Clinical & Epidemiology Services, Leuven, Belgium; International Alliance of Biological Standardisation (IABS-EU), Lyon, France

作者Bhaskar Ganguly; Rajashakar Bellamcapu; Madhavi Charepalli; Sai Krishna Susarla; Sindhura Rao Akkala; Devi Prasad Sahoo; Sunil Tiwari; Santosh Balasaheb Ghadage; Anand Kumar Kanakasapapathy; Mysore Kalappa Sudarshan

作者单位Human Biologicals Institute, Indian Immunologicals Limited, Rakshapuram, 500032, India; Independent Consultant, Bangalore, 560004, India

作者Shalini Rajagopal; Rob Tierney; Jason Hockley; Paul Stickings; Laura Hassall

作者单位Medicines and Healthcare products Regulatory Agency (MHRA), South Mimms, Hertfordshire, EN6 3QG, UK