Northway Biotech Information

Northway Biotech is a Contract Development and Manufacturing Organization (CDMO) located in Waltham, MA, USA, and Vilnius, Lithuania, EU. Extensive expertise in drug substance and drug product development, as well as GMP compliant manufacturing, makes us exceptionally well-versed in all aspects of the biopharmaceutical value chain – from gene to drug manufacturing in microbial and mammalian expressions systems. Our customers appreciate our ability to react rapidly to unexpected project changes, adjusting timelines, and availability of additional capabilities to meet our customers' evolving needs. We are deeply invested in providing high-quality, world-class contract development and manufacturing services with vast flexibility and responsiveness backed by a strong foundation in science and technology innovation. Northway Biotech end-to-end services include: Cell Line (Mammalian & Microbial) Development Analytical Methods Development Formulation Development Upstream & Downstream Process Development (USP & DSP) cGMP Manufacturing of Biologics & Biosimilars (Drug Substance, Drug Product) cGMP Master and Working Cell Bank Manufacturing cGMP pDNA Manufacturing Fill & Finish (F&F) Quality Assurance, Quality Control, and Regulatory CMC Support