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Pion’s instruments are 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:
- 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 vivotesting where possible
- Site-to-site and patient-to-patient variability affecting the bioavailability of the biopharmaceuticals