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