Insights from PSC Manufacturing Expert Panels: Quality and Innovation in Stem Cell Banking
The International Stem Cell Banking Initiative (ISCBI) hosted the PSC Manufacturing Expert Panels on June 30, 2019, in Los Angeles, CA, focusing on key challenges and advancements in pluripotent stem cell production. Discussions revolved around defining and ensuring quality attributes, robust testing methodologies, and international standardization in manufacturing. Participants shared insights on topics such as tumorigenicity testing, comparability in cell therapies, and the road ahead for automated manufacturing processes. The panels aimed to foster collaboration and progress in stem cell technologies.
Insights from PSC Manufacturing Expert Panels: Quality and Innovation in Stem Cell Banking
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Presentation Transcript
International Stem Cell Banking Initiative (ISCBI) Panel #:Title PSC Manufacturing Expert Panels 2019 June 30th 2019, Los Angeles, CA. Participants: Names (affiliation) Chairs: Name (affiliation)
Pics and Names/Affiliations of Participants PSC Manufacturing Expert Panels 2019 June 30th 2019, Los Angeles, CA.
Title 1 e.g. Quality • How is Quality defined? Critical Quality Attributes vs For Information Only • Critical Quality Attributes for PSCs • What should we do now to ensure our Critical Quality Attributes are up to scratch? • Are the Critical Quality Attributes for iPSC published by GAiT in 2018 still fit for purpose, what needs to change? If so what? PSC Manufacturing Expert Panels 2019 June 30th 2019, Los Angeles, CA.
Title 2 e.g. Quality Testing • Have we good robust quality tests for CQAs? • How do we ensure that our testing for CQA is consistent in absence of Pharmacopeial guidance. Quality Round first step? PSC Manufacturing Expert Panels 2019 June 30th 2019, Los Angeles, CA.
Remember Chairs! Take note of the biggest 2-6 takeaway messages from your panel panel and send them to stephen.sullivan@gait.global after your panel so we can summarize Panels in the last session - Thanks. Know what the other panels are talking about and allude to them where appropriate Panel 1: Organizers discussing key takeaways from last year’s CIRM/IABS and their takes on progress made over the last year Panel 2: Pluripotent stem cells as manufacturing cell substrates - challenges encountered and forecast Panel 3: International standardisation of human pluripotent stem cell manufacturing - rationale and review of current status Panel 4: Defining Quality Parameters of Human Pluripotent Stem Cells as manufacturing intermediates for therapeutic development Panel 5: Outlining a road map to cell therapy comparability Panel 6: Towards standardized tumorigenicity testing - challenges and the way forward Panel 7: Towards automated and closed human Pluripotent Stem Cell Manufacture Panel 8: Financial and Logistical Challenges to human Pluripotent Stem Cell Manufacture Panel 9: Avoiding immunorejection and engraftment failure - challenges and the way forward Panel 10: Organizers summarizing and highlighting upcoming events PSC Manufacturing Expert Panels 2019 June 30th 2019, Los Angeles, CA.
