Sirius Scissor

In vitro testing for injection site events for biopharmaceuticals

Sirius Scissor

The biopharmaceutical market has grown rapidly in the past 30 years, principally in the last decade. This has been driven by the discovery of new molecules and innovative therapies. However, the way biopharmaceuticals behave immediately after administration is still largely unknown. The Sirius Scissor is the first instrument designed to simulate the stress conditions and environmental transitions that a biopharmaceutical drug experiences upon injection into a subcutaneous (SC) environment.

These include chemical stresses such as:

  • Different buffer composition

  • pH change

  • Loss of excipients

And physical stresses such as:

  • Temperature

  • Pressure

  • Non-specific interactions with extracellular matrix (ECM) components

These transitional stresses can lead to poor in vivo bioavailability; with the lack of understanding in this area potentially severely impacting the drug development process leading to costly setbacks.

Well reported issues with current testing protocols:

  • Extremely poor correlation between animal models and human outcomes

  • High cost and inherent variability associated with in vivo models

  • Political desire to reduce in vivo testing where possible

  • Site-to-site and patient-to-patient variability affecting the bioavailability of the biopharmaceuticals

Sirius Scissor provides:

  • A novel in vitro model for investigating the bioavailability of SC or IO formulations under simulated physiological conditions

  • Possibility of different run times suitable for different release profiles

  • Monitoring of pH change upon injection

  • Generation of time release concentration profiles through offline analysis