Slobodanka Cirin-Varadjan
Slobodanka Cirin-Varadjan is Associate Director at Syneos Health®
JournalFDA comparability guidance: The impact of cell and gene therapy products
This article analyses FDA draft guidance and other guidance documents and aims to address concerns about CGT products.
JournalUnique aspects of biologic reference standards
Reference standards are pivotal in ensuring pharmaceutical quality, especially for complex biologics. This article reviews definitions and classifications of reference standards as outlined by the US Food and Drug Administration (FDA), the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q6B and Q7 guidelines. It addresses types of standards based on source and use, with particular emphasis on the distinct requirements for biologics.
