iPSC Manufacturing Summit in Boston, 26th-28th July 2022
GAiT was able to articulate the value of its entire program of work over the last 5 years as it contributed to both workshops, chairing the morning sessions for each day of the summit, as well as speaking and leading an audience discussion session. GAiT spoke to many topics including Donor Suitability Criteria, Critical Quality Attributes, the implementation of a Quality by Design approach to iPSC Manufacture, and the importance of the Quality Assessment Rounds carried out in collaboration with CiRA/CiRA Foundation. It highlighted its collaboration with other organizations such as ISCT, CiRM, and ISCBI. It also led an audience discussion focused on iPSC analytics where GAiT highlight its upcoming flow cytometry workshop.
Two other USA based organizations ARMi & BioFabUSA also contributed, taking feedback from the audience as to the priority of current challenges. The discussions were equivalent to those already taking place within the GAiT Industry Liaison Committee and indeed several companies that are on that Committee articulated the value of their involvement with GAiT during the Summit.
The audience comprised employees from Ajinomoto Inc, Akron Biotech, Applied StemCell, ARMI, Asahi Kasei Corp., Asimov Inc., Aspen Neuroscience, Astellas Venture Management LLC, bit.bio, BlueRock Therapeutics, BrainXell, Inc., Bristol Myers Squibb, Canventa Life Sciences, CCRM, Cellgorithmics, Cellino Biotech Inc., Century Therapeutics LLC, City of Hope National Medical Center, Editas Medicine, Elevate Bio, Exacis Biotherapeutics, Fate Therapeutics, FUJIFILM Cellular Dynamics Inc, Garuda Therapeutics, Heartseed Inc, HebeCell, Hopstem Biotechnology Ltd, Icahn School of Medicine at Mount Sinai, Lonza, MAGic BioProcessing, Mayo Clinic, MilliporeSigma, Ncardia/Cellistic, NIH, Notch Therapeutics, Novoglia Inc, PBS Biotech Inc., Penn State, Regenerative Patch Technologies, Resilience, Shoreline Biosciences, Takeda Pharmaceutical Co. Ltd., The Broad Institute of MIT & Harvard, ThermoFisher Scientific, Thymmune Therapeutics, TreeFrog Therapeutics, Umoja Biopharma, University of Minnesota, and Vita Therapeutics.
Summary and Materials
Pre-Summit Workshops: Regulatory Requirements and Automation