Northway Biotech

Vilnius, LT; Waltham (MA), USA
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29
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 2026-04-29)
Quality Compliance
100.0/100 — No FDA inspection records found for this manufacturer
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
No ClinicalTrials.gov matches confirmed
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

Quality Compliance 100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
EMA GMP Certificates8 on record
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs no verified data
Sponsorsno verified data
ModalitiesBiologics, mAbs, Recombinant proteins, pDNA, AAV, Viral vectors, Gene Therapy
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability 60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity 68.0
2 manufacturing sites
Broad modality coverage (7 modalities)
Sites: Vilnius, LT, Waltham (MA), USA
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
StatusAvailable
2 manufacturing sites
Broad modality coverage (7 modalities)
Sites: Vilnius, LT, Waltham (MA), USA
2 manufacturing sites
Broad modality coverage (7 modalities)

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 May 20, 2026
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Biologics CDMOs → mAbs CDMOs → Recombinant proteins CDMOs → pDNA CDMOs → AAV CDMOs → Viral vectors CDMOs → Gene Therapy CDMOs →

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