ITRI’s hydrogel technology is specially designed to locally deliver the active pharmaceutical ingredients consisting of biologics, such as antibodies and proteins, in controlled or sustained release. Unlike existing protein delivery systems with significantly limited clinical uses due to insufficient drug loading (<15 mg/mL), our hydrogel technology has a high protein loading capacity (>150 mg/mL). This technology has also overcome many technical challenges including protein stability and bioactivity during fabrication and release period, incomplete release from the matrix, product injectability issue and so on. Most of all, our in vivo studies used HerceptinR as an example and showed that ITRI’s novel hydrogel systems given by subcutaneous injection reduced Cmax of the antibody in blood plasma and offered at least four times prolongation of the half-life through controlling its sustained release from the hydrogel matrix. In addition, the efficacy result (PD) in a xenograft model of human breast cancer in mice showed that HerceptinR formulated with the hydrogel exhibited the enhanced efficacy of suppressing tumor growth, indicating that the antibody released from the hydrogels can retain its native anti-tumor potency. We believe these breakthrough technology will bring more broad application for biologics.
水膠組合物由低濃度(2~5 wt%)具生物相容性之polypeptide及poly(ethylene glycol)構成，具有多孔結構且能包覆高濃度蛋白質藥物(高達200 mg/mL)，並應用於蛋白質藥物控制釋放。
A hydrogel composition comprising polypeptide and poly(ethylene glycol) of low polymer concentration (2~5 wt%), which has the porous structure and can load high-concentration (up to 200 mg/mL) protein drugs, can be applied to the controlled release of protein drugs.
1.100% drug encapsulation efficiency
2.High antibody loading concentration (up to 200 mg/mL)
3.Sustained release over 5 weeks (in vitro and in vivo)
4.Intact stability and antigen binding affinity of antibody released from hydrogel
5.Unchanged anti-proliferation and ADCC capability of antibody released from hydrogel
6.Alterable release rate of antibody by changing composition of the formulation
7.Cmax reduction (40-70%) and T1/2 extension (up to 4.2 fold) for the trastuzumab antibody
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