New paper: Reversible protein complexes - Advancing subcutaneous delivery with controlled and sustained release of high concentration biologics
"High concentration formulations are crucial in developing biological drugs, especially for subcutaneous (SC) administration where the administered dose is adversely impacted by the limited injection volume. In this study, we evaluated the fate and behavior of high concentration formulations of biologics, using the previously described reversible protein complex (RPC) approach and a novel in vitro tool called Subcutaneous Injection Site Simulator (SCISSOR)...
In this study, high concentration formulations of biologics were achieved with five therapeutic proteins using the reversible protein complex technology...
Our findings suggest that the SCISSOR can provide a suitable tool to predict the stability of biological drugs in the subcutaneous environment. Also, the in vitro drug release data obtained from the SCISSOR highlighted a sustained and controlled release of RPC formulations and a surface erosion-based release mechanism was elucidated thanks to in vitro release models."
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