PolyTherics moves lead candidate into development and manufacturing with DSM BioSolutions
PolyTherics has applied its HiPEG™ site-specific PEGylation technology to interferon alpha to produce a product (HiPEG™ IFN alpha-2a) that has eight-fold higher activity than a marketed PEGylated interferon in vitro and a comparable half-life in a preclinical study.
HiPEG™ specifically attaches poly(ethylene) glycol (PEG) to a histidine tag at the end of the protein; histidine tags are commonly used to improve protein stability and to facilitate the purification of proteins. PolyTherics is seeking partners for the development of HiPEG™ IFN alpha-2a for hepatitis C.
DSM has successfully started development, scale-up and manufacture of the recombinant his-tagged IFN alpha-2a. PolyTherics will transfer its proprietary HiPEG PEGylation method to DSM so that the process can also be scaled-up. The companies intend to develop a robust process to produce sufficient material for preclinical development and then for cGMP production of HiPEG™ IFN alpha-2a for clinical development.
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