International Alliance for Biological Standardization

I’m proud to be part of an organization that puts global public health first. An honor for me to work with such dedicated people.

A vibrant organization that allows dialogue beyond professional boundaries. The true application of One Health !

As a long term US regulator and scientist, I have been working with IABS for many years. The IABS has assisted in providing scientific data and transparency to aid developers and regulators in making safe and effective biological products and in affecting important public health decisions.

Kathryn Zoon
NIH Scientist EmeritusPast | NIAID Scientific Director 2005-2015 | Past FDA CBER Director 1992-2002 | Past WHO Expert Committee on Biological Standardization 1997-2016

Cell substrates have been a key element in the evolution of biological products since the earliest days of vaccine development. The introduction of cell culture into the manufacturing process for vaccines in the 1950s and the identification of SV-40 as a contaminant of the Salk polio vaccine marked the first of many cell substrate issues that emerged over the next 50+ years. In each of those episodes, IABS played an important role in resolving the issues. The next major cell substrate event was the introduction of human diploid cells into vaccine development and production, and IABS was a significant player. It was during that period that IABS began to work closely with WHO in trying to move a new technology forward by providing a forum for clarifying the issues, discussing the scientific data, and achieving consensus recommendations. The next cell substrate event occurred in the 1980s with the consideration of continuous cell lines (CCLs) for monoclonal antibodies and for rDNA products. Numerous conferences sponsored by IABS, often in cooperation with WHO, led to the eventual acceptance of CCLs for use in the manufacture of biological products. The most recent cell substrate issues in which IABS has been involved relate to cell and gene therapy. The issues are complex and difficult to resolve, but IABS, in conjunction with WHO and other professional scientific organizations, has once again taken the lead in providing a neutral venue for regulatory authorities, manufacturers, and academicians to discuss the scientific issues and to develop consensus recommendations for consideration by regulatory agencies as they provide guidance for researchers, developers and manufacturers of this new class of biologicals.

I have appreciated the achievements of IABS since many years. It is a unique independent organization that can make the link between public health needs, industry development and scientific advances in the area of Safety Regulations for Medical Products. It is filling an important gap and it is now particularly reassuring to observe the continuing activities of IABS at a time of global health crisis.