Northway Biotech
Vertically integrated biologics CDMO with 20+ years expertise in protein and gene therapy development and manufacturing.
End-to-end CDMO specializing in protein-based biologics and gene therapies, with 20+ years of expertise and cGMP facilities in Lithuania and Massachusetts supporting development from preclinical to commercial stages. Headquartered in Vilnius, Lithuania.
Modalities
Development & manufacturing
Structured CDMO capabilities from verified public sources.
Development (D)
Manufacturing (M)
Regulatory clearances
Services
Indications
About this organization
Northway Biotech is a contract development and manufacturing organization (CDMO) focused on protein-based biologics and gene therapies (pDNA and viral vectors). The company operates state-of-the-art facilities in Vilnius, Lithuania and Waltham, Massachusetts, offering vertically integrated services across the full development and manufacturing lifecycle.
Development Services:
- Cell line development (mammalian and microbial expression systems)
- Process development (upstream and downstream processing)
- Analytical methods development
- Formulation development
- Viral clearance studies (ICH Q5A(R2) compliant, FDA/EMA regulatory support)
cGMP Manufacturing:
- Cell banking
- Drug substance production
- Drug product manufacturing (aseptic fill-finish)
- Multiple production units supporting mammalian cell culture and microbial processing
Quality & Regulatory:
- Quality assurance and quality control
- Regulatory affairs support (IND/BLA/IMPD documentation)
- Full regulatory compliance across development and commercial stages
The company has demonstrated expertise in engineered endolysin therapies and supports clients from preclinical through commercial manufacturing with rapid project execution and comprehensive regulatory guidance.
Locations
Headquarters
Vilnius · Vilnius · Lithuania
US Facility
Waltham · Massachusetts · United States
Recent news about Northway Biotech
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