Northway Biotech is a global end-to-end CDMO specializing in protein-based biologics and gene therapy, supporting AAV, lentiviral, and other viral vector programs. With over 20 years of experience and 205+ successful client programs, we provide fully integrated solutions — from cell line development and process development to cGMP Drug Substance and Drug Product manufacturing, including viral clearance studies.

Our cGMP facilities in Vilnius, Lithuania, and Waltham, MA, enable rapid and scalable manufacturing from early development through clinical and commercial phases. Recognized for scientific excellence, regulatory compliance, and a collaborative approach, Northway Biotech accelerates biologics and gene therapy development with speed, precision, and flexibility.

Type of Drugs Manufactured:
Protein-based Biologics; Gene Therapy

CDMO Services:
• Drug Substance Manufacturing (Biologics)
• Drug Product Formulation (FDF)
• Aseptic Fill–Finish
• Research & Development
• Analytical Development
• Regulatory Services
• Process Development (Upstream & Downstream)
• Cell Line Development
• Technology Transfer & Scale-Up
• Quality Control & Quality Assurance (GMP)
• Stability Studies
• Packaging, Labeling & Supply Chain Logistics
• Project Management
• Viral Vector Manufacturing (AAV, LV, AV)
• Plasmid DNA Manufacturing

No. of Manufacturing Facilities:
2

Facilities Locations:
Europe; North America

Manufacturing Technologies:
antibodies (mAbs), peptides, proteins, hormones & enzymes, ATMPs (advanced therapies),
injectables, fill & finish, small-volume vials, PFS (pre-filled syringes), cartridges, FDF / drug
products, biologics, viral vectors, API processing/manufacturing