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Micreos, Northway Biotech Partner to Develop Scalable cGMP Production Processes

Will advance Micreos’ engineered endolysin therapeutic manufacturing program.

Micreos Pharmaceuticals AG, a preclinical-stage biopharmaceutical company, has entered into a strategic partnership with Northway Biotech, a Contract Development and Manufacturing Organization (CDMO), to develop scalable cGMP production processes for Micreos’ biologic therapeutic MEndoB, a first-in-class dual-active domain targeted medicine that will enter the clinic in the coming months as an investigational therapeutic to treat Atopic Dermatitis.

As part of the partnership, Northway Biotech will apply its expertise in biologics manufacturing to develop a scalable GMP production process for Micreos’ engineered endolysin technology. The collaboration will also include developing and validating robust analytical methods, cell bank manufacturing, technology scale-up for cGMP Drug Substance generation, and IND/IMPD supporting documentation preparation, to ensure that the production of Micreos’ engineered endolysins complies with stringent regulatory standards for clinical trials.

Matt Regan, CEO of Micreos, stated: “This partnership with Northway Biotech marks a significant milestone for Micreos as we advance our engineered endolysins into scalable therapeutics for clinical trials. By developing targeted medicines that address the underlying pathophysiology associated with disease aggravation in conditions such as atopic dermatitis and cutaneous T-Cell lymphoma, and by leveraging Northway’s significant manufacturing expertise, we are poised to make a meaningful impact on patient care in areas of great unmet medical need.”

Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech, added: “We are honored to contribute to Micreos’ innovative engineered endolysin therapies. With a dedicated and highly experienced team in recombinant protein process development and scale-up, we aim to accelerate Micreos’ development by providing cGMP drug substance material available by the end of summer 2024.”

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