Northway Biotech

Vilnius, LT; Waltham (MA), USA
No confirmed program data — ClinicalTrials.gov verification pending · Last scored 2026-09-07
80.8
Signal Score
○ FDA Inspections ○ Clinical Trials ○ SEC Filings ○ Press ✓ EMA GMP (8) ○ MHRA GMP

Quick Facts: Northway Biotech

Signal Score
80.8/100 (as of 2026-09-07)
Quality Compliance
100.0/100
Headquarters
Vilnius, LT; Waltham (MA), USA
Founded
2004
Max Bioreactor Scale
4,000 L
Website
Modalities
Biologics, mAbs, Recombinant proteins, pDNA, AAV, Viral vectors, Gene Therapy
Active Programs
Data pending
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CDMO intelligence platform

About Northway Biotech

The Vilnius facility recently strengthened by the 2024 inauguration of a dedicated Gene Therapy Center and a growing team of over 200 specialized professionals overall. Our infrastructure supports both mammalian and microbial expression systems with significant scale-up potential, featuring cGMP manufacturing capacities of up to 4,000 L and 3,000 L, respectively. This dual-track versatility allows for the seamless transition of diverse modalities from initial cell line development through rigorous process optimization and characterization. Technical excellence is sustained through a fully integrated service suite that encompasses analytical method development and qualification, alongside in-house virus clearance studies to ensure the highest safety standards. Downstream, our capabilities extend to advanced Drug Product manufacture, providing precision filling for vials, syringes, and cartridges. This technical continuum is finalized by robust Quality Control services and strategic Regulatory Affairs support, facilitating the preparation of comprehensive CMC documentation to streamline the path toward global clinical and commercial approval.

Signal Score & Pillar Breakdown

Scores are being republished. Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.
Quality Compliance 100.0
FDA InspectionsNo US records on file
EMA GMP Certificates8 on record
Operations —
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs — no verified data
Sponsors— no verified data
ModalitiesBiologics, mAbs, Recombinant proteins, pDNA, AAV, Viral vectors, Gene Therapy
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability 60.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity 68.0
Capacity status: Available
StatusAvailable

Northway Biotech EMA GMP Compliance 8 certificates

2026-01
2025-11
2025-01
2022-10
2019-04
2019-02
2017-06
2016-04
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
LT/01H/2026 Biotechnologines farmacijos centras Biotechpharma UAB Lithuania 2026-01-14 COMPLIANT
LT/10H/2025 Biotechnologines farmacijos centras Biotechpharma UAB Lithuania 2025-11-26 COMPLIANT
LT/01H/2025 Biotechnologines farmacijos centras Biotechpharma UAB Lithuania 2025-01-30 COMPLIANT
LT/07H/2022 Biotechnologines farmacijos centras Biotechpharma UAB Lithuania 2022-10-14 COMPLIANT
LT/05H/2019 UAB Biotechnologinės farmacijos centras "Biotechpharma" Lithuania 2019-04-11 COMPLIANT
LT/03H/2019 UAB Biotechnologinės farmacijos centras "Biotechpharma" Lithuania 2019-02-28 COMPLIANT
LT/09H/2017 Biotechnologinės farmacijos centras "Biotechpharma" Lithuania 2017-06-02 COMPLIANT
LT/07H/2016 UAB Biotechnologinės farmacijos centras "Biotechpharma" Lithuania 2016-04-28 COMPLIANT
Source: EMA EudraGMDP · Retrieved Oct 07, 2026

Frequently Asked Questions About Northway Biotech

Does Northway Biotech hold EMA or MHRA GMP certificates?
CDMO Signal tracks 8 EMA GMP certificates for Northway Biotech.
What is Northway Biotech's CDMO Signal Score?
Northway Biotech has a Signal Score of 81/100, based on quality, operations, financial stability, and capacity data.
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