Discussion

Cell Therapy Challenges

Industry shift towards advanced biologics and cell therapeutics

Large difference between three methods:
Traditional Process – Synthetic Chemistry / Small Molecule
Cell Based – Autologous Process
Cell Based- Allogeneic Process

Drugs are living cells and viability is key

Requires ultra cold chain (cryogenic) integrated throughout the process flow which differs from traditional

Scale-up issues from PI to PIII

Commercialization & regulation pathway which is largely undefined