Overview

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

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