DSM BioSolutions ("DSM"), DSM's microbial fermentation CMO business unit and PolyTherics Limited (PolyTherics), a biopharmaceutical company that applies precision chemistry to develop improved protein and peptide-based drugs, announced that they have entered into an agreement for the process development and manufacture of PolyTherics' lead biobetter product, HiPEG IFN alpha-2a.

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.

Keith Powell, CEO of PolyTherics, said, "The transfer of the production of our lead product to a contract manufacturer is a major milestone for PolyTherics and is the beginning of the development stage of its first biobetter drug."

Villaume Kal, Vice-President of DSM BioSolutions stated, "We are delighted to work with PolyTherics on this promising biobetter compound. Our technology, operational excellence, and outstanding cGMP and compliance record with the EMA and FDA allows us to serve this important customer and to develop, scale-up and manufacture their preclinical and clinical material".