Overview
Northway Biotech is a leading global CDMO specializing in protein-based biologics and advanced therapies. With over 20 years of experience and a track record of 210+ completed projects, we partner with clients worldwide to advance programs from early development through clinical and commercial manufacturing.
Located in the Greater Boston area, our state-of-the-art Waltham, MA site serves as a premier US center for end-to-end development and cGMP manufacturing of microbial (E. coli, yeast) and mammalian (CHO, HEK) therapeutics. Our expertise spans monoclonal antibodies, bispecific and multispecific antibodies, fusion proteins, enzyme replacement therapies, cytokines, plasmid DNA (pDNA), and more.
Waltham Site Capabilities
- Cell Line & Process Development: Mammalian and microbial cell line development, supported by fully integrated upstream and downstream process development (USP/DSP).
- Technology Transfer: Seamless and efficient transfer of processes from partners, including confirmation runs prior to scale-up.
- Analytical & Formulation: End-to-end, in-house analytical method development, qualification, and validation, coupled with liquid and lyophilized formulation development.
- cGMP Manufacturing: Drug substance manufacturing for biologics and biosimilars, including plasmid DNA (pDNA) production and Master and Working Cell Bank (MCB/WCB) generation. Microbial and pDNA production scales up to 300 L (working volume), and mammalian production up to 2,000 L.
- Fill & Finish: cGMP aseptic filling of liquid and lyophilized drug products in vials, prefilled syringes, and cartridges.
- Quality & Regulatory Support: Integrated Quality Assurance (QA) and Quality Control (QC), with expert CMC support for IND- and BLA-enabling activities.
Backed by a team of 200+ professionals across 3 sites in the US and Lithuania, Northway Biotech delivers the technical expertise, operational flexibility, and reliability needed to accelerate your journey from molecule to market.
Explore how we can accelerate your project – connect with us: www.northwaybiotech.com