Terminal Sterilization Using g-Irradiation

One of the ultimate goals of biopharmaceutical product development is to provide a safe and effective product. Towards that end, there has been a long-standing interest in terminal sterilization, using methods that would inactivate pathogens of all types, including non-enveloped viruses. While g-irradiation has the potential to inactivate all types of pathogens, it also can cause substantial damage to proteins and peptides. In partnership with another company, we have developed formulation strategies that reduce the level of damage exhibited by proteins, even at relatively high doses of radiation. We would welcome the opportunity to evaluate g-irradiation as a potential terminal sterilization step for your biopharmaceutical or combination product.