Provider profile

Northway Biotech.

Biologics CDMOs

Northway Biotech describes cell line and strain, process, analytical and formulation development and cGMP drug substance and drug product (fill and finish) manufacturing of antibodies and recombinant proteins from mammalian and microbial systems, plus plasmid DNA, viral vectors and cell therapies, for clinical and commercial supply. It lists biologics sites in Vilnius, Lithuania and Waltham, Massachusetts.

Website: northwaybiotech.com (opens in a new tab)
Sources reviewed: November 4, 2026 · Source pages re-checked within 4 months
First published: November 3, 2026

This profile summarizes what public sources state about the provider, mostly its own website. It is not an audit, qualification or endorsement by ArgusBio. Confirm capabilities directly with the provider before contracting.

Services and capabilities

Analytical development and QC testing1,4
Cell line development5,6
Formulation development7
GMP drug product manufacturing1,5,6In-house aseptic fill and finish: three lines across Vilnius and Waltham (vials, prefilled syringes, cartridges, lyophilization)
GMP drug substance manufacturing1,5
Lyophilization7Stated as liquid and lyophilized formulation development; lyophilization is also listed under aseptic fill and finish at both sites
Process development1,2,3
Stability studies8,9
Technology transfer1,8

Platforms and methods

Mammalian cell culture5,7
Microbial fermentation1,6,10Bacterial and yeast fermentation; microbial manufacturing up to 3,000 L working volume
Single-use bioreactors7,8Single-use mammalian bioreactors (10 L to 4,000 L in Vilnius; 10 L to 2,000 L in Waltham)

Drug substance / drug product

Drug product5,6
Drug substance1,5

Development experience

Development stage

Commercial3,11
Phase 17Stated as team experience with S2 insect-cell expression programs, not as a company production record
Phase 27Stated as team experience with S2 insect-cell expression programs, not as a company production record
Phase 37Stated as team experience with S2 insect-cell expression programs, not as a company production record

Modality

Cell therapies1Autologous and allogeneic cell therapy development and cGMP manufacturing stated for a Vilnius facility
Gene therapies1,8Viral vector and plasmid DNA development and cGMP manufacturing stated for Vilnius
Monoclonal antibodies2,7
mRNA and nucleic acids8Plasmid DNA development and manufacturing; mRNA itself not documented
Recombinant proteins1,2

Locations

Vilnius, Lithuania · Manufacturing site5Biologics (mammalian single-use 10–4,000 L, microbial 10–4,500 L) drug substance and aseptic fill and finish; Vilnius also hosts the gene therapy (pDNA, viral vector) and cell therapy CDMO facilities
Waltham, United States · Manufacturing site6Waltham, Massachusetts: biologics (mammalian single-use 10–2,000 L, microbial 45–450 L) drug substance and aseptic fill and finish

Quality and regulatory

The provider’s own materials state that it works to, or holds, the following. ArgusBio has not inspected or audited these claims.

GMP / cGMP1

Unknowns and questions to ask

Public sources rarely establish what matters most for a specific project. Confirm directly:

Available capacity, slot timing and scale for your next campaign
Recent experience with your specific modality and expression system or chemistry
Regulatory inspection history of the specific site that would manufacture your product
Technology-transfer approach, timeline and who owns the resulting process knowledge
Analytical and QC release testing done in-house versus subcontracted
Quality agreement terms, batch-failure responsibility and change-order mechanics

Choosing a CDMO: a practical guide

Evidence and sources

1cGMP Manufacturing | Northway Biotech (opens in a new tab)Northway Biotech · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
2Cell Line & Strain Development Services | Northway Biotech (opens in a new tab)Northway Biotech · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
3Microbial Biologics | Northway Biotech (opens in a new tab)Northway Biotech · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
4Analytical Methods Development | Northway Biotech (opens in a new tab)Northway Biotech · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
5Biologics CDMO Site | Vilnius, Lithuania | Northway Biotech (opens in a new tab)Northway Biotech · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
6Biologics CDMO Site | Boston, MA | Northway Biotech (opens in a new tab)Northway Biotech · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
7Mammalian Biologics | Northway Biotech (opens in a new tab)Northway Biotech · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
8Process Development | Northway Biotech (opens in a new tab)Northway Biotech · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
9Quality & Regulatory Support | Northway Biotech (opens in a new tab)Northway Biotech · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
10Plasmid DNA Manufacturing | Northway Biotech (opens in a new tab)Northway Biotech · Provider website · retrieved November 3, 2026 · last checked November 3, 2026
11End-to-end Biologics CDMO | Northway Biotech (opens in a new tab)Northway Biotech · Provider website · retrieved November 3, 2026 · last checked November 3, 2026

“Last checked” means we confirmed the page was still available and still contained the cited statement. It does not mean ArgusBio verified the provider or its capabilities.

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