Superior CGT Platform
- Simplest way to produce a drug product
- Least variables to control to assure drug product quality
- World’s only linearly scalable CGT technology
- FDA & EMA have sanctioned miniature G-Rex devices as a “qualified reduced scale model” as a surrogate for full-scale G-Rex clinical and commercial production
- Miniature G-Rex devices enable full-scale manufacturing with least amount of time and money
- The only technology that can be used across all CGT functions:
- R&D
- Preclinical
- Clinical
- Commercial
- Fully automatable with robotics and integrated Process Analytic Technology (PAT)
- Proof of technological superiority
- G-Rex is the world’s most robust commercial manufacturing platform (CARVYTKI®)
Market Leader
- G-Rex is used to make five commercially approved drug products including CARVYTKI®, the world’s most successful CAR-T cell therapy:
- CARVYTKI® has treated the most patients (over 9000) in the least amount of time since launch
- CARVYTKI® is highly profitable with a gross margin of ~60% and annual sales over $1B (blockbuster status)
- G-Rex is used by ~50% of clinical trial sponsors in the USA
- CAR-T, TCR-T, TIL, NK, HSC, Treg, γδ T cells, etc.
- G-Rex is used in virtually every academic center doing CGT research & development
- G-Rex has been cited in >1,000 peer-reviewed publications
- $42M G-Rex Grant Program is currently sustaining the next generation of cell and gene-modified cell therapies
- Audited by many CGT companies, including 22 within the last year and have never had a major finding.