Barcode-Activated Cell Sorter for Mass Production of FDA-Compliant Transplantable Cells

Funding Type: 
Tools and Technologies II
Grant Number: 
RT2-01940
Investigator: 
ICOC Funds Committed: 
$0
oldStatus: 
Closed
Public Abstract: 
Stem cells provide the starting material for cell replacement in tissues that are damaged as a result of disease, infection, congenital abnormalities, or trauma. Human pluripotent stem cells (PSCs) can generate multiple cell types and thus hold the greatest promise for future therapeutic applications. As PSCs differentiate in vitro into a mixture of different lineages, purification of the differentiated cells, as well as separation from their tumor-forming progenitors, is essential before PSC derivatives can be used in cellular therapies. For “cellular therapy” or “stem cell products”, sorting and purification processes that adhere to Good Manufacturing Process (GMP) are absolutely required. In the field of regenerative medicine, therefore, there is an urgent need for a robust cell culture strategy (or “process”) that allows the reproducible generation of a well-defined population of cells from a defined starting population of pluripotent stem cells in a GMP-compliant manner. This type of process-based approach is the only one likely to be acceptable to the FDA for INDs (Investigational New Drug) proposing immune-matched, patient-specific stem cell therapies. The research teams propose to develop a highly innovative Barcode-Activated Cell Sorter (BACS) chip and system that can be used to purify large numbers of differentiated cells for therapeutic purposes. The BACS platform combines the technologies of Barcoded Magnetic Beads (BMB), differentiated cell biomarkers, and a microfluidic magnetic sorter to rapidly capture, identify, and concentrate millions of specific cells for downstream applications. The BACS chip is disposable, easily replaceable, and always operates in a "sterile" mode. The system will uniquely enable specific cell types to be identified and selected in parallel from a highly heterogeneous cell culture without physical manipulation. No contamination of cells or sample carry-over will occur in the system. This novel BACS technology will be especially suitable for isolation of differentiated PSCs for cell-based human therapies.
Statement of Benefit to California: 
Stem cells provide the starting material for cell replacement in tissues that are damaged as a result of disease, infection, congenital abnormalities, or trauma. For “cellular therapy” or “stem cell products”, sorting and purification processes that adhere to Good Manufacturing Process (GMP) are absolutely required. The research teams propose to develop a highly innovative Barcode-Activated Cell Sorter (BACS) chip and system that can be used to purify large numbers of differentiated cells for therapeutic purposes. The success of the project will lead to the development of a commercially viable prototype with more barcoded beads representing different cell lineages and lineage members. This will enable rapid and high-confidence lineage purification and cell sorting for many different human cell-based therapies in a GMP-compliant manner. The success of the proposed project will lead to the mass production of stem cells in the State of California. Since [REDACTED] are located in the California, the production facility will be also in California. Although stem cell industry is still in the embryonic stage, in the foreseeing future, it will be matured into the development and product industry. High demand of high quality and high purity stem cell products is expected. To meet the growing demand, the company will require hiring more scientists, system engineers, biologists, QC, production, sales, and marketing peoples.

© 2013 California Institute for Regenerative Medicine