Product Development & Translational Research
The CellReGen™ program develops new cell therapy products, promotes interaction among multidisciplinary investigational teams, and raises community awareness about the exciting potential of stem cell-based products and therapies. CellReGen™ strives to be the premiere translational program in the Mountain West, bridging the application of discovery research to clinical trials and commercialization.
Services provided to develop and manufacture novel cellular therapy products include:
- Bench-to-bedside translational research assistance
- Technology transfer
- Cell isolation, characterization and purification
- Scale-up
- Process optimization and validation
- Assistance with Investigational New Drug (IND) submissions
- Technical expertise in cGMP manufacturing
- Development of standard operating procedures and batch records
- Cell expansion , master and working cell bank production
- Support of Phase I/II Clinical Trials
- Quality Assurance
- Vendor Qualification
- Risk Assessment
- Product stability
- Regulatory guidance and oversight
- FDA Guidance
- Investigational New Drug Applications (IND)
- Chemistry, Manufacturing, Controls (CMC)
- Clinical Trial Support
- Institutional Review Board (IRB)
