Northway Biotech, a biopharmaceutical contract development and manufacturing organization (CDMO), established in 2004, with an EMA and FDA-compliant, state-of-the-art, cGMP manufacturing site in Europe, has opened its new 30,000-square-foot process development and cGMP manufacturing site in Waltham, MA.
 
From cell line development to cGMP DS manufacturing and aseptic filling, the state-of-the-art facility, in the booming biotech hub in the Greater Boston area, will provide end-to-end services for biologics microbial and mammalian-based biologics. Currently, the new site has fully established process, analytical method development, and quality control labs supporting local and international customer projects since summer 2020. The cGMP biomanufacturing suite will house 500 L microbial and 2,000 L mammalian bioreactors and be operational in Q4 2021, representing a capital investment program worth $40 million.
 
“Northway Biotech reaches an important strategic milestone to further strengthen its leadership by opening a second biomanufacturing facility and its first in the U.S,” said Vladas Algirdas Bumelis, chief executive officer, Northway Biotech. “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.”
 
Earlier last month, the company announced that it is changing its brand name from Northway Biotechpharma to Northway Biotech to harmonize its brand name across EU and U.S.-located sites.