Report of a WHO workshop on implementation of the WHO manual for the preparation of reference materials for use as secondary standards in antibody testing

Overview

Following the development and publication of a WHO manual for the preparation of reference materials for use as secondary standards in antibody testing, WHO held a workshop for regulators and manufacturers to support the implementation of its recommendations. The workshop was held in Indonesia from 14-16 November 2023 for the countries were identified there is a need for establishing secondary standards. This workshop was participated by the representatives of national regulatory authorities, national control laboratories from Bangladesh, China, Egypt, India, Indonesia, Iran, Malaysia, Republic of Korea, Saudi Arabia, Thailand, Tunisia, and Viet Nam, as well as representatives from industry, GSK, Serum Institute of India, Bharat Biotech International Ltd., Bio-Manguinhos, and Bio Farma. The workshop was facilitated by experts from regulators with rich experience on establishment of biological standards. The workshop consisted of a series of presentations and four case studies based on the content of the manual. Working through the case studies, the workshop participants, supported by experienced facilitators, demonstrated a sound understanding of the concepts and issues covered by the manual.