AI Article Synopsis
- - Sessions provided an overview of previous cell therapy conferences, focusing on challenges related to human pluripotent stem cells and key areas like manufacturing, bioanalytics, tumorigenicity testing, and logistics.
- - Panel discussions emphasized the need for coordinated efforts among emerging standardization groups and the importance of conducting a gap analysis of current regulatory guidelines.
- - IABS and CIRM plan to collaborate with stakeholders to create a practical roadmap aimed at supporting developers of early cell therapy products.
Article Abstract
Sessions included an overview of past cell therapy (CT) conferences sponsored by the International Alliance for Biological Standardization (IABS). The sessions highlighted challenges in the field of human pluripotent stem cells (hPSCs) and also addressed specific points on manufacturing, bioanalytics and comparability, tumorigenicity testing, storage, and shipping. Panel discussions complemented the presentations. The conference concluded that a range of new standardization groups is emerging that could help the field, but ways must be found to ensure that these efforts are coordinated. In addition, there are opportunities for regulatory convergence starting with a gap analysis of existing guidelines to determine what might be missing and what issues might be creating divergence. More specific global regulatory guidance, preferably from WHO, would be welcome. IABS and the California Institute for Regenerative Medicine (CIRM) will explore with stakeholders the development of a practical and innovative road map to support early CT product (CTP) developers.
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| http://dx.doi.org/10.1016/j.biologicals.2018.08.004 | DOI Listing |
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