Global CDMO Northway Biotech Opens $40 Million Facility in Greater Boston

Biopharmaceutical contract development and manufacturing organization (CDMO) Northway Biotech, which was previously Northway Biotechpharma, has opened a new $40 million 30,000-square-foot process development and Current Good Manufacturing Practice (cGMP) manufacturing site in Waltham, Mass.

Privately-owned Northway Biotech was founded in 2004 in Vilnius, Lithuania. The company’s cGMP manufacturing site in Europe is compliant with both European Medical Agency and U.S. Food and Drug Administration (FDA) regulations. In addition to the new site in the booming biotech hub in Boston and the Lithuania site, the CDMO also has a site in London, U.K.

Northway Biotech’s new state-of-the-art facility in the Greater Boston area will offer several production services, including cell line development, cGMP dietary supplement manufacturing and aseptic filling. End-to-end services will focus on microbial biologics and mammalian-based biologics.

The Mass.-based cGMP biomanufacturing site, which has established process, analytical method development and quality control labs to support local and international projects, represent a capital investment program valued at up to $40 million. The site will house 2,000 L mammalian and 500 L microbial bioreactors, and the full suite of services will reportedly be operational in the last quarter of 2021.

"Northway Biotech reaches an important strategic milestone to further strengthen its leadership by opening a second biomanufacturing facility and its first in the United States,” Northway Biotech’s CEO and Executive Chairman of the company's Board of Directors and Advisory Board, Dr. Vladas Algirdas Bumelis, said in a statement. “We are very excited about this expansion and are poised to support our next-door partners in the Boston biotech hub, as well as other domestically or internationally located companies, by enabling accelerated development and manufacturing of their novel, life-saving biopharmaceuticals for clinical or commercial needs.”

Back in August 2020 when Northway Biotech was Northway Biotechpharma, Memo Therapeutics entered into a partnership with the company to fast-track a SARS-CoV-2-neutralizing antibody for the treatment of COVID-19. Northway Biotech agreed to develop the cell line and take control of the manufacturing process. Additionally, the CDMO signed into agreement that it would produce cGMP batches of Memo’s antibody for clinical trials.

The collaboration had an impressive timeframe for development – four months. Memo Therapeutics, which plans to start clinical trials sometime in 2021, presented “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,” said Northway’s Vice President of Business Development Dr. André Markmann.

Demands within the global pharmaceutical CDMO services market have been on the rise as of late, primarily due to the increased need for safer and more effective treatments at lower production costs.

Another global CDMO, Cognate BioServices, also recently announced plans to expand its manufacturing capacity, warehousing capabilities, laboratory space and office support in additional facilities in the U.S. and Europe. The CDMO’s existing global manufacturing facility and headquarters are located in Memphis, Tenn., a city that will see two separate facility additions from Cognate.

These facilities will include a distribution center for managing global supply chain needs as well as another site focused solely on commercial manufacturing. The new additions in Memphis will total up to 250,000 new square feet of space.