Vilnius, Lithuania, and Schlieren, Switzerland – August 11, 2020 – Northway Biotechpharma (Northway), a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Swiss biotech company Memo Therapeutics AG (MTx), announce a new partnership to manufacture MTx’s therapeutic COVID-19 antibody candidate in a 4-month fast-track process approved by regulatory authorities.
MTx today announces a collaboration with Northway to establish fast-track cGMP manufacturing for its lead antibody candidate for the treatment of COVID-19. MTX-COVAB is a fully human, highly potent antibody isolated from clinically selected convalescent COVID-19 donors with picomolar neutralizing activity against wild-type SARS-CoV-2, as well as newly described mutants. The selected antibody will undergo an accelerated development program as an immunotherapy and for the prevention of COVID-19.
Under the terms of the manufacturing agreement, Northway will develop the cell line and the manufacturing process, and will further produce cGMP batches of MTx´s antibody for clinical studies. Northway is also perfectly positioned to execute commercial production once MTX-COVAB receives marketing authorization. This will enable MTx to supply the market in time for the anticipated second wave of the pandemic.
Northway produces antibodies and other mammalian cell-based therapeutics up to the 2.000 L scale in single-use bioreactors at its current facilities. A larger-scale production facility using stainless-steel bioreactors will be made operational by the start of 2021 to facilitate ramping-up of capacity to meet MTx´s demand. This project leverages the innovative discovery research and applied cGMP manufacturing know-how of the two partners.
“Based on outstanding efficacy data from our MTX-COVAB clinical candidate, regulatory authorities fully support MTx’s development plan for a fast-track approach towards market authorization. We are confident that we will be equipped to serve patients’ needs by the start of 2021”, explained Dr. Karsten Fischer, CEO of Memo Therapeutics.
“It is a great pleasure to support MTx’s programs and to personally contribute to the global fight against COVID-19 by employing our technical know-how and excellent cGMP manufacturing capabilities”, said Dr. Vladas Bumelis, Executive Chairman of the Board of Northway Biotechpharma.
Dr. André Markmann, VP Business Development of Northway Biotechpharma, added: “MTx has very aggressive timelines due to the global health threat and therefore needs a partner that is able to respond to their demands rapidly while also providing a high-quality service. They have selected Northway Biotechpharma as we are able to meet these needs.”
About Northway Biotechpharma - https://www.northwaybiotech.com
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 facilities 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, and in Waltham, Boston, US.
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About Memo Therapeutics - https://memo-therapeutics.com/
Memo Therapeutics AG (MTx) is an innovator in the field of antibody discovery and immune repertoire analysis.
MTx’s antibody discovery platform uses robust, simple and fast microfluidic single-cell molecular cloning and screening technologies to enable antibody repertoire mining and antibody discovery at unprecedented speed, efficiency and sensitivity.
The platform captures and preserves entire B-cell repertoires from any donor species and any B-cell type in recombinant form for display using mammalian cells. The antibody repertoires are subsequently screened in single-cell format using microfluidic screening technology that can assess millions of candidate antibodies directly in functional assays, resulting in recombinant clonal cell lines expressing mAbs with the desired functional properties.
Exploiting the power of its microfluidic single-cell molecular cloning and screening technologies, the company engages in antibody discovery across species and indications for proprietary and partnered projects.
MTx’s current pipeline features programs in infectious diseases and immuno-oncology.
MTx is a private company located in Bio-Technopark Zurich, Switzerland.
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Northway Biotechpharma and Memo Therapeutics AG collaborate on the fast-track manufacturing of a SARS-CoV-2-neutralizing antibody for the therapy of COVID-19