Northway Biotech
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
- https://www.northwaybiotech.com/
- 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
EMA GMP Compliance 8 certificates
| 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 |