Development of a low-cost, clinical-grade iPS maintenance medium for enabling stem cell therapy manufacturing
Grant Award Details
Grant Type:
Grant Number:
TRAN4-15298
Investigator(s):
Human Stem Cell Use:
Award Value:
$999,848
Status:
Active
Grant Application Details
Application Title:
Development of a low-cost, clinical-grade iPS maintenance medium for enabling stem cell therapy manufacturing
Public Abstract:
Translational Candidate
HiDef-B8, an iPS cell maintenance medium designed to reduce stem cell GMP manufacturing costs and risk.
Area of Impact
HiDef-B8 addresses scale-up manufacturing, by being lower-cost ($300/L) and requiring fewer passages per week (1-2 as opposed to 3-5).
Mechanism of Action
HiDef-B8 underwent extensive empirical optimization and alternative component screening, focused on reducing cost, maintaining iPS cell pluripotency and robustness, and enabling weekend-free, minimal-passage stem cell culture. This included the implementation of FGF2-G3, a novel thermostable variant that enables improved medium stability and half-life in culture. These changes enable lower-cost cell culture and fewer passages, minimizing manufacturing errors and contamination risk.
Unmet Medical Need
iPS cell-derived therapy candidates are quickly emerging to target a wide range of diseases and disorders. Scale-out (autologous) and scale-up (allogeneic) processes will require cost-effective media with minimal user handling to be a widely applicable technology. HiDef-B8 is engineered for this.
Project Objective
Readiness for transfer to manufacturing
Major Proposed Activities
HiDef-B8, an iPS cell maintenance medium designed to reduce stem cell GMP manufacturing costs and risk.
Area of Impact
HiDef-B8 addresses scale-up manufacturing, by being lower-cost ($300/L) and requiring fewer passages per week (1-2 as opposed to 3-5).
Mechanism of Action
HiDef-B8 underwent extensive empirical optimization and alternative component screening, focused on reducing cost, maintaining iPS cell pluripotency and robustness, and enabling weekend-free, minimal-passage stem cell culture. This included the implementation of FGF2-G3, a novel thermostable variant that enables improved medium stability and half-life in culture. These changes enable lower-cost cell culture and fewer passages, minimizing manufacturing errors and contamination risk.
Unmet Medical Need
iPS cell-derived therapy candidates are quickly emerging to target a wide range of diseases and disorders. Scale-out (autologous) and scale-up (allogeneic) processes will require cost-effective media with minimal user handling to be a widely applicable technology. HiDef-B8 is engineered for this.
Project Objective
Readiness for transfer to manufacturing
Major Proposed Activities
- Manufacture 300 L of analytical QC-validated HiDef-B8 via cGMP methods for clinical application.
- Evaluate cGMP-grade HiDef-B8 for proliferation, pluripotency, karyotype, and differentiation.
- Evaluate cGMP-grade HiDef-B8 in large-scale clean room production for proliferation, pluripotency, karyotype, and differentiation.
Statement of Benefit to California:
This application is focused on enabling cost-effective scaled manufacturing of iPS cell-derived therapeutic technologies, which will benefit all demographics of the nearly 40 million people in California who, at some point, may suffer a condition that would benefit from such technologies. Ease of scaled cell manufacturing enables competitive therapy development and more affordable solutions. It also increases the number of cell therapy producers and associated businesses and jobs in the state.