FDF / DRUG PRODUCTS BIOLOGICS SERVICES API PROCESSING in Europe
Global End-to-End Biologics CDMO
About the plant
Northway Biotech is a global end-to-end CDMO specializing in protein-based biologics and gene therapy, offering services for AAV, lentiviral, and other viral vector programs. With over 20 years of experience and 205+ successful client programs, we provide integrated solutions — from cell line development to manufacturing of cGMP Drug Substance and Drug Product, including viral clearance studies.
Our cGMP facilities in Vilnius, Lithuania, and Waltham, MA, support rapid, scalable manufacturing from early development to commercial phases. Known for scientific excellence, regulatory compliance, and a collaborative approach, Northway Biotech helps clients accelerate gene therapy development with speed, precision, and flexibility.
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- French Service-Public (CIR)
- SFDA (Saudi Food & Drug Authority)
Activity
- Abs (Antibodies), Peptide, protein, hormone & enzyme, ATMP (Advanced Therapies), Injectables, Fill&Finish, Small volume vials, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS, BIOLOGICS, SERVICES, API PROCESSING manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
- DEA: N/A
- BSL: 1, 2, 3
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), EDE (UAE), MFDS (South Korea), SFDA (Saudi Arabia)
Batch Size / Reactor
- Small, Medium, Large, Batch, Fed-batch, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, 2000 - 5000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Preformulation studies, Formulation / Galenic design, Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission
