Year 1

First year progress on grant ID1-06557, ” Generation and Characterization of High-Quality, Footprint-Free Human Induced Pluripotent Stem Cell (iPSC) Lines From 3000 Donors to Investigate Multigenic Disease” has met all agreed-upon milestones. In particular, Cellular Dynamics International (CDI) has taken lease to approximately 5000 square feet of lab space at the Buck Institute for Research on Aging in Novato, CA. The majority of this space is located within the new CIRM-funded Stem Cell Research Building at the Buck Institute and was extensively reconfigured to meet the specific needs of this grant. All equipment, including tissue culture safety cabinets and incubators, liquid-handling robotics, and QC instrumentation have been installed and qualified. A total of 16 scientists have been hired and trained (13 in Production and 3 in Quality) and more than 20 Standard Operating Procedures (SOPs) have been developed and approved specifically for this project. These SOPs serve to govern the daily activities of the Production and Quality staff and help ensure consistency and quality throughout the iPSC derivation and characterization process. In addition, a Laboratory Information Management System (LIMS) had to be developed to handle the large amount of data generated by this project and to track all samples from start to finish. The first and most important phase of this LIMS project has been completed; additional functionalities will likely be added to the LIMS during the next year, but completion of phase 1 will allow us to enter full production mode on schedule in the first quarter of year 2. Procedures for the shipping, infectious disease testing, and processing of donor samples were successfully implemented with the seven Tissue Collectors. To date, over 700 samples have been received from these Tissue Collectors and derivation of the first 50 patient-derived iPSC lines has been completed on schedule. These cells have been banked in the Coriell BioRepository, also located at the Buck Institute. The first Distribution Banks will be available for commercial release during year 2.