Vilnius, Lithuania, and Lund, Sweden - December 20th, 2019 – Northway Biotechpharma, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, today announced a new service agreement to develop the next generation of IgG cleaving enzymes.
Under the terms of this agreement, Northway Biotechpharma will transfer the process developed by Hansa Biopharma to its state-of-the-art R&D and cGMP manufacturing facility to perform further process optimization work. Subsequently, the process will be scaled-up for cGMP manufacturing of the Drug Substance including the production of the Drug Product for Hansa Biopharma´s clinical studies.
Prof. Vladas Bumelis, Executive Chairman of the Board of Northway Biotechpharma, said, “We have developed a strong and successful partnership with Hansa Biopharma over the years and we are happy to extend this cooperation by supporting the development of their new drug candidate”.
“This second project which we will run for Hansa Biopharma will certainly benefit from the manufacturing process and the analytical panel synergies resulting from the previous project. Additionally, our capability as a true one-stop-shop CDMO will add to the smooth execution of all CMC-activities,” added Dr. André Markmann, VP Business Development of Northway Biotechpharma.
Søren Tulstrup, President and Chief Executive Officer of Hansa Biopharma, commented: “We greatly value our professional relationship with Northway Biotechpharma and this project is a cornerstone in developing the next generation of IgG cleaving enzymes to potentially enable repeat dosing in relapsing autoimmune diseases and oncology”.
About Hansa Biopharma - https://hansabiopharma.com
Hansa Biopharma leverages its proprietary immunomodulatory enzyme technology platform to develop treatments for rare immunoglobulin G (IgG)-mediated autoimmune conditions, transplant rejection, and cancer. The Company’s lead product candidate, imlifidase, is a unique antibody-cleaving enzyme that potentially may enable kidney transplantation in highly sensitized patients with potential for further development in other solid organ transplantation and acute autoimmune indications. Hansa’s research and development program is advancing with the next-generation technology to develop novel IgG-cleaving enzymes with lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden and also has operations in Europe and the US.
About Northway Biotechpharma
Northway Biotechpharma is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company’s wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facility while ensuring full process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotechpharma is a privately owned company founded in 2004 and located in Vilnius, Lithuania.
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