Collaborators
Juan Arciniega, D.Sc.
Affiliate at Biologics Consulting
Dr. Juan L. Arciniega is a consultant on biological products. He retired in 2018, after working as a Microbiologist for 29 years at the Center for Biologics Evaluation and Research (CBER) of the US Food and Drug Administration (FDA). He received a Doctor of Science degree in Clinical Biology in 1987 from the National School of Biological Sciences in Mexico City. Before joining CBER in 1989 as a Visiting Fellow, he worked for nine years in different capacities at the Mexican National Public Health Laboratory, most recently as Deputy Director for Biological Control, where he was in charge of two departments responsible for sanitary testing of food and biologics. He was also a founding member of the Permanent Commission of the Mexican Pharmacopoeia (Biologics and Bioassay and Statistics Committees).
His research and regulatory activities focused on pertussis, diphtheria, and anthrax vaccines, and the development of alternatives to animal tests. Dr. Arciniega’s last position at CBER was as a CMC consult reviewer, with special emphasis on methods development, validation, and quality control. Additionally, he participated in other regulatory activities such as batch release. He acted as a CBER/FDA liaison with the US Pharmacopeia (Biologics and Biotechnology 2 Expert Committee) from 2010 to 2015. He has published more than 30 papers in his field and regularly referees manuscripts for several journals. He has cooperated with the World Health Organization (WHO) and the Pan American Health Organization (PAHO) as a Temporary Advisor, and with the European Center for the Validation of Alternative Methods (ECVAM) and the European Directorate for the Quality of Medicines and Healthcare (EDQM). Dr. Arciniega mentored several young Latin American vaccine regulators and other scientists.