The company recently welcomed an international delegation of ministers and local officials for a tour of the 30,000 square-foot (2787 sq. m) Waltham, Massachusetts-based site, which is slated to create 50 new jobs.
Northway, which describes itself as a client centric mid-sized CDMO with experience working with biotech startups, has been operating a manufacturing plant in Vilnius, Lithuania, for over 17 years.
The company is part of the burgeoning life sciences sector in Lithuania, which, according to Innovation Agency Lithuania, is growing at the fastest rate in the EU, 16% annually, with exports contributing significantly to the growth, which increased by 62% in 2020 alone.
Upstream and downstream process development
The new US facility, said the CDMO, adheres to US Food and Drug Administration (FDA) good manufacturing practice requirements. The site is outfitted with both single-use and stainless-steel systems for upstream and downstream process development, formulation, and fill-finish of microbial and mammalian cell culture-based products for the development of monoclonal antibodies and recombinant proteins.
“The facility's flexible design and integrated infrastructure will enable the development, formulation and manufacturing of clients' proteins and antibodies, while aseptic drug product manufacturing capabilities will add further value to customers' projects from a timeline and cost perspective.”
Ben Bradford, VP of economic development and workforce at MassBio, an organization charged with growing the life sciences industry in Massachusetts, said that Northway's offering will complement the strong community of service organizations in the region focused on supporting biopharma companies in advancing their products through the drug development pipeline.
Privately owned Northway, which was founded in 2004, said it can rapidly execute multiple projects from the two GMP facilities while ensuring full process and product compliance at all stages of research, development, and commercial manufacturing.
Tech transfer between sites
“Among the many benefits of having sites both in Waltham and in Lithuania is the ease with which experience, technology, processes and products can be seamlessly transferred from the US to Europe for approval in either place. Our clients will ultimately benefit from one company operating across two sites, both providing reliable, extensive experience," said Northway CEO, Vladas Bumelis.
December 2021 saw the Lithuanian CDMO sign an agreement with Sydney, Australia headquartered, Immutep, to manufacture a its preclinical candidate for autoimmune diseases, an immunosuppressive agonist antibody to LAG-3, ahead of clinical testing.