Hao Liu
Hao Liu is Senior Director at Syneos Health®
JournalGene Therapy Medicinal Products: An examination of regulatory CMC requirements
This article explores the CMC requirements for GTMPs to help ensure high quality and safe products are brought to market.
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.
