Cell Therapy Manufacturing

Glyn Stacey has a background in microbiology and cancer research and has worked on the development of cell substrates for manufacture of biological medicines for over fifteen years. He is currently at the National Institute for Biological Standards and Control which is a part of the Medicines and Healthcare Products Regulatory Agency. He is Head of Division of Cell Biology and Imaging and Director for the UK Stem Cell Bank (UKSCB). The work of his group covers safety and quality issues in cell therapy, cells used for manufacturing purposes, development of novel cell-based assays and the development of reference materials for tissue typing and diagnosis of genetic disorders. This work includes the need for scale up of preservation techniques and long term storage of DNA and cell lines of various types including human stem cell lines and cells used in bioassays and vaccine production.Tongbiao Zhao is a principal investigator at the Institute of Zoology, Chinese Academy of Sciences, where he leads the Laboratory of Stem Cell and Immunology. He also serves as Joint Deputy Dean of the Beijing Institute for Stem Cells and Regenerative Medicine and Joint Professor at the University of the Chinese Academy of Sciences. His research primarily focuses on stem cell immunology and translational stem cell research. His team has pioneered stem cell immunology; their seminal discovery of induced pluripotent stem cell immunogenicity has reshaped clinical strategies for stem cell translation, highlighting the need to induce immune tolerance. Additionally, his team has identified oxidative phosphorylation and heightened autophagic flux as intrinsic metabolic features critical for maintaining pluripotent stem cell identity. Serving as the Director of the Standard Working Committee of the Chinese Society for Cell Biology and as a member of TC276 of the International Organization for Standardization and the International Society for Stem Cell Research, he has coordinated interdisciplinary experts to develop standards supporting stem cell applications and achieved groundbreaking advancements, including the establishment of a series of seminal national and international stem cell standards.

• The development of gene edited cell therapies: challenges and solutions .- Combined advanced therapies: challenges and solutions.- Developing advanced therapies in a challenging patent and legal environment: perspectives on current and future cell therapies .-  Developing Ethical perspectives on advanced therapies and future challenges .- Modelling adequate reimbursement for cell therapies .- Facilitating international coordination of manufacturers and regulators .- The future of reference materials for cell therapies .- Experiences Development of ISO standards for cell therapies .- NIST activities in development of standards for cell therapies .- FIRM and Japanese standardization initiative for regenerative medicine .- The industry perspective: ARM SBC and ASTM  .- Development of cell therapy regulation: the Japanese experience.- MFDS and Korean regulation .- Australian approaches to regulation .- EU regulatory processes for cell therapy applications .- Canadian cell therapyregs .- Development of cell therapy regulation: the US perspective.