Slobodanka Cirin-Varadjan
Slobodanka Cirin-Varadjan is Associate Director at Syneos Health®
JournalManaging ATMP lifecycle complexity: Navigating post-approval CMC divergence in Asia-Pacific
This article reviews three post-approval CMC challenge areas in ATMP development: ongoing data commitments, comparability requirements for manufacturing process changes and variation classification, and proposes a five-point framework intended for practical use within the current Asia-Pacific regulatory environment
JournalCell therapy, gene therapy and tissue-engineered product manufacturing: Technical challenges, enablers and regulatory evolution
This article examines the barriers that constrain cell and gene therapy accessibility, discusses emerging solutions and highlights current regulatory expectations
JournalDemystifying complex generic products: Regulatory pathways and characterisation
This article explores complex generic products, providing guidance for their definition and classification.
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This article analyses FDA draft guidance and other guidance documents and aims to address concerns about CGT products.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.
