Regen CTC provides translational consulting services for the development of human pluripotent stem cell (hPSC)-derived therapies, focusing on quality management systems, bioprocess development, and clinical trial design. The company addresses the challenges of moving cell therapies from bench research to clinical application by leveraging a network of academic experts and industry specialists.
Funding
Funding not disclosed
Founders
Product
Problem
Developing human pluripotent stem cell (hPSC)-derived therapies is complex, requiring specialized expertise in quality management systems, bioprocess development, and clinical trial design. Early-stage product developers often lack the resources and experience to navigate the translational pathway from bench research to clinical application.
Solution
Regen CTC provides translational consulting services to support the development of hPSC-derived therapies. The company leverages a network of academic experts and industry specialists to address the challenges of translating cell therapies to the clinic. Regen CTC offers stage-appropriate quality management systems, assistance with selecting contract manufacturing partners, supplier qualification and raw material selection, cell line selection, bioprocess development, clinical trial design, gap analysis, and due diligence.
Target Audience
Regen CTC serves early-stage product developers, researchers, and companies involved in the development of human pluripotent stem cell (hPSC)-derived therapies.
Features
- Stage-appropriate quality management systems development
- Contract manufacturing partner selection support
- Supplier qualification and raw material selection guidance
- Cell line selection assistance
- Bioprocess development services in partnership with Advance Bioprocess Services
- Clinical trial design expertise
- Gap analysis and due diligence services
- Contract research opportunities in partnership with Advance Bioprocess Services