SNS Densomere™
Terminal Sterilization
SNS Densomere™ Sterilization
E-Beam sterilization of SNS products tested with both large and small molecules
Standard SAL targeted with E-Beam dosing may eliminate post-sterilization testing
SNS Densomere not adversely affected by terminal sterilization with E-Beam
Studies indicate molecular integrity and bioactivity retained for large (149 kD) MAb products after E-Beam terminal sterilization
The Challenge of Biologics Sterilization
- To sterilize biologics in a time- and cost-efficient manner that minimizes infection through elimination of microorganisms without affecting bioactivity
- This now requires fully aseptic manufacturing facilities adhering to validated protocols that processes and assembles all materials in a controlled aseptic environment utilizing detergents, antifungals, or chemical disinfectants of equipment and packaging
Retention of Bioactivity post-Terminal Sterilization
Neo-vascular Inhibition with sterilized MAb in Rabbit Corneal Suture Model
Day 7
Control
Subconjunctival post-e-beam
Day 28
Day 53
Retention of Bioactivity post-Terminal Sterilization
Neo-vascular Inhibition with sterilized MAb in Rabbit Corneal Suture Model
Day 7 – Control
Day 7 – Subconjunctival post-e-beam
Day 28 – Control
Day 28 – Subconjunctival post-e-beam
Day 53 – Control
Day 53 – Subconjunctival post-e-beam
Neovascular Inhibition in Rabbit Corneal Suture Model
Densomeres with SNS-300 MAb, Post Terminal Sterilization
