DSM BioSolutions To Manufacture PolyTherics Biologic

DSM BioSolutions, DSM’s microbial fermentation CMO business unit, and PolyTherics Ltd. have entered into an agreement for the process development and manufacture of PolyTherics’ lead “biobetter” product, HiPEG IFN α-2a. Financial terms were not disclosed.

PolyTherics applied its HiPEG site-specific PEGylation technology to interferon alpha to produce HiPEG IFN α-2a, which in a preclinical study showed eight-fold higher activity than a marketed PEGylated interferon in vitro, and a comparable half-life. PolyTherics is seeking partners for the development of HiPEG IFN α-2a for hepatitis C.

DSM has successfully started development, scale-up and manufacture of the recombinant his-tagged IFN α-2a. PolyTherics will transfer its HiPEG PEGylation method to DSM for scale-up. The companies plan to develop a process to produce sufficient material for preclinical and clinical development.

Keith Powell, chief executive officer 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 said, “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.”