With decades of biopharmaceutical industry experience in CGMP facility design, software, engineering, manufacturing and Quality operations, Lykan Bioscience provides the first true end-to-end solution for cell-based therapies, including shipping and logistics.
Our experienced team provides Process Development and CGMP manufacturing for autologous and allogeneic cell-based therapies in concert with our Quality Management System which serves the entire product lifecycle.
Lykan can meet your immediate needs with capacity availability and also offer long-term vision toward scalability, validation and high-throughput commercial manufacture of your cell-based therapies, whether they are CAR-T, TCR, TIL, iPSC, or other platforms.
Overview of Capabilities & Services:
- Cell & Gene-Mediated Cell Therapy CGMP Manufacturing
- Autologous and Allogeneic
- Platforms: CAR-T, TCR, TIL, iPSC, etc.
- Clinical through Launch to Commercial
- Technology Transfer and Gap Assessment
- Method & Process Development
- Full Analytical Services
- On-site Quality Control
- On-site Quality Assurance
- Method & Process Validation
- CGMP Stability
- Regulatory Support for filings and inspections
- Ordering & Scheduling
- Product Shipping and Logistics to / from Healthcare Providers
- Client Dashboard Visibility
- Long term storage in our Cell Pharmacy