samedan logo
 
 
spacer
home > news > detailed info
INDUSTRY NEWS AND PRESS RELEASES

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

Northway Biotechpharma


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 for fast-track cGMP manufacturing of 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 path 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.

For Further Information Contact:vladas.bumelis@northwaybiotech.com

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 Bcell 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.

For Further Information Contact:media@memo-therapeutics.com
email bd@northwaybiotech.com
web https://www.northwaybiotech.com/
email Northway Biotechpharma Mokslininku str. 4 LT-08412 Vilnius, Lithuania
 
Print this page
Send to a friend
   
spacer
News and Press Releases

European Medicines Agency Begins Rolling Review of Moderna’s mRNA Vaccine Candidate Against COVID-19 (mRNA-1273)

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 17, 2020-- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the European Medicines Agency (EMA) human medicines committee (CHMP) has started a rolling review of mRNA-1273, the Company’s vaccine candidate against COVID-19, following the confirmation of eligibility of mRNA-1273 for submission on October 14, 2020.
More info >>


White Papers

Sourcing Commercial Drugs for Clinical Trials: US vs. EU Understanding the Differences

Myoderm

Sourcing commercial drugs for clinical trials is a dynamic process. There are many factors to consider: single source or regional sourcing, strategy, price, supply availability, lead times, and documentation are just a few. In the past, there were fewer clinical trials that required commercial drug sourcing, so demand was not as high. Today, the demand for commercial drugs in clinical trials has greatly increased and, as a result, inventory is tighter, orders are monitored more closely by manufacturers, and lead times have increased. This report highlights the key differences in sourcing from the US and EU.
More info >>

Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement