Changes in the protein environment as it transitions from a stabilized, formulated drug product in an appropriate container to the subcutaneous tissue environment can drastically impact the structural stability and integrity of the injected protein. Further, interactions of the protein with components of the extracellular matrix can lead to changes in its structure, potentially impacting both safety and efficacy.
Investigating protein stability in the subcutaneous space for formulation optimization and improved clinical outcomes is critically important in subcutaneously-delivered drug development. Analytical techniques can reveal significant alterations in protein structure after subcutaneous administration, necessitating early evaluation of protein stability. One such analytical technique is the Subcutaneous Injection Site Simulator (SCISSOR.)
In a recent paper, “Assessing physiochemical stability of monoclonal antibodies in a simulated subcutaneous environment,” investigators explored monoclonal antibodies (mAbs) to detect biophysical and chemical changes, including post-injection in an in vitro, simulated, subcutaneous space. They found that all their mAb samples showed signs of reduced stability and conformational change after injection.
The authors concluded, “The SCISSOR offers a unique opportunity for early screening of the in vivo performance of subcutaneously administered therapeutics in preclinical evaluation and formulation development. …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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