PAPER SUMMARY:
Assessing Physicochemical Stability of Monoclonal Antibodies in a Simulated Subcutaneous Environment
"The Subcutaneous Injection Site Simulator (SCISSOR) developed by Kinnuman and Mrsny is a recent, commercially available in vitro instrument that simulates the subcutaneous injection space. The system models environmental changes that a protein could experience as it transitions from a stabilized drug product environment to the physiological environment of the subcutaneous injection site.
The SCISSOR instrument employs an injection chamber filled with a synthetic ECM that is separated from the simulated interstitial fluid by a dialysis membrane. This injection chamber is immersed in a compartment filled with a carbonate-based buffer that mimics the interstitial fluid of the SC space and the infinite sink of the body. A biotherapeutic injected into the chamber diffuses out via diffusional movement through the dialysis membrane into the infinite sink compartment, thus simulating movement of a drug from the site of injection to the blood capillaries or lymph nodes. To date, the SCISSOR has primarily been used to rank order formulations based on their release profiles, co-relate absorption data to in vitro bioavailability, and identify formulation critical quality attributes for protein, peptide, and even small molecule therapeutics.
The SCISSOR offers a unique opportunity for early screening of the in vivo performance of subcutaneously administered therapeutics in preclinical evaluation and formulation development. In this study, we demonstrate a novel application for the SCISSOR combined with downstream offline analytical and biophysical techniques to identify and characterize potential structural changes in mAbs after subcutaneous administration."
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