It is challenging to predict how Active Pharmaceutical Ingredients (APIs) such as Monoclonal Antibodies (mAbs), peptides and hormones will be impacted by the injection process and entry into the subcutaneous layer. The application of shear stress during the injection process, changes in temperature and pressure, and chemical stresses such as changes in buffer composition and pH all have the potential to trigger aggregation or denaturation of the biomolecule or precipitation of small molecule APIs. These effects can lead to poor in vivo release characteristics, compromising bioavailability and clinical efficacy, and in the worst case, safety.
The Pion Subcutaneous Injection Site Simulator (SCISSOR) is an in vitro model that investigates the release performance of subcutaneous formulations under simulated physiological conditions. It assesses the risk and performance of subcutaneously administered drugs including biologics, peptides and small molecules.
An article entitled, The Impact of Injection: Representative In Vitro Testing for Subcutaneous Drug Delivery in American Pharmaceutical Review discusses this injection site simulator technology in more detail and how it is used for rank ordering biopharmaceutical injections. SCISSOR allows users to screen excipients and compare different formulations to identify the best candidates for further development. The instrument mimics the stresses a biopharmaceutical experiences when transitioning from formulation conditions to a subcutaneous environment and potential precipitation events can be monitored and correlated to lymphatic and systemic release dynamics quantified. When coupled with the Rainbow R6 in-situ fiber optic UV-vis spectrometer, lymphatic and systemic release data can be measured in-situ giving real-time results and enriching the data collection process.
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