---
name: Northway Biotech
slug: northway-biotech
site: cdmo
website_domain: northwaybiotech.com
summary: 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.
tagline: Vertically integrated biologics CDMO with 20+ years expertise in protein and gene therapy development and manufacturing.
founded_year: 2004
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: LT
tier2_domain_verified: false
updated_at: 2026-09-05T00:01:37.753Z
services_count: 11
modalities_count: 2
indications_count: 1
locations_count: 2
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Northway Biotech

Vertically integrated biologics CDMO with 20+ years expertise in protein and gene therapy development and manufacturing.

Listed on cdmo.directory.

## Summary

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.

## At a glance

- Founded: 2004
- HQ country: LT

## Services

- Cell-Line Development
- Process Development
- Upstream Processing
- Downstream Processing
- CMC Analytical Development
- Formulation Development
- Stability Testing & Storage
- Quality Control Testing
- CMC Regulatory Submission Support
- Recombinant Protein Manufacturing
- Biologics Development & Manufacturing

## Modalities

- Biologics (Other)
- Gene Therapy

## Indications

- Dermatology

## Locations

- Headquarters, Vilnius, Vilnius, Lithuania
- US Facility, Waltham, Massachusetts, United States

## Long description

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.

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- [Enzene Biosciences](/companies/enzene) (Cell-Line Development, Process Development) — [Compare](/compare/enzene/northway-biotech)
- [Charles River Laboratories](/companies/criver) (Cell-Line Development, Process Development) — [Compare](/compare/criver/northway-biotech)

_Profile last updated: 2026-09-05T00:01:37.753Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.