Northway Biotech
Northway Biotech is an innovative and fast-growing contract development and manufacturing organization (CDMO) specializing in the development and manufacturing of biologics, gene therapies, and biopharmaceutical products. With over 20 years of expertise and state-of-the-art facilities in the EU and US, Northway Biotech supports clients across all development stages, from cell line development to commercial manufacturing, ensuring full regulatory compliance and high-quality service.
Industries
Nr. of Employees
medium (51-250)
Northway Biotech
Products
Drug Substance Manufacturing
Flexible cGMP drug substance manufacturing services including mammalian cell culture and microbial fermentation capabilities across European and US facilities.
Northway Biotech Global End-to-End Biologics CDMO
An end-to-end contract development and manufacturing organization (CDMO) specializing in the development and manufacturing of protein-based biologics and gene therapies.
Viral Clearance Studies
Full-service viral clearance studies (VCS) to validate the effectiveness of purification processes in removing or inactivating viral contaminants in compliance with ICH Q5A(R2) guidelines.
Process Development Services
R&D process development services for cell line development, USP and DSP processes establishment, and analytical support to enable efficient transfer and scale-up for production.
Cell Banking Services
cGMP Master and Working Cell Banks (MCB/WCB) production and characterization to support long-term manufacturing needs for microbial and mammalian cultures.
Drug Product
Flexible, state-of-the-art R&D and cGMP manufacturing facilities for sterile drug product fill-finish, including liquid and lyophilized sterile drug product into vials, pre-filled syringes, and cartridges.
Drug Substance Manufacturing
Flexible cGMP drug substance manufacturing services including mammalian cell culture and microbial fermentation capabilities across European and US facilities.
Northway Biotech Global End-to-End Biologics CDMO
An end-to-end contract development and manufacturing organization (CDMO) specializing in the development and manufacturing of protein-based biologics and gene therapies.
Viral Clearance Studies
Full-service viral clearance studies (VCS) to validate the effectiveness of purification processes in removing or inactivating viral contaminants in compliance with ICH Q5A(R2) guidelines.
Process Development Services
R&D process development services for cell line development, USP and DSP processes establishment, and analytical support to enable efficient transfer and scale-up for production.
Cell Banking Services
cGMP Master and Working Cell Banks (MCB/WCB) production and characterization to support long-term manufacturing needs for microbial and mammalian cultures.
Drug Product
Flexible, state-of-the-art R&D and cGMP manufacturing facilities for sterile drug product fill-finish, including liquid and lyophilized sterile drug product into vials, pre-filled syringes, and cartridges.
Services
Generation and optimization of production cell lines and creation of master cell banks to support biologics production.
Development and optimization of upstream and downstream processes, including scale-up to clinical and commercial volumes.
Design, development and qualification of analytical methods supporting characterization, release and stability testing.
Optimization of drug product formulations and associated stability testing to support clinical and commercial product profiles.
Full-service viral removal and inactivation study programs with regulatory-compliant reporting, available standalone or as part of integrated CDMO projects.
cGMP production of biologic drug substances and aseptically filled drug products for clinical and commercial supply, across microbial and mammalian platforms.
Generation and optimization of production cell lines and creation of master cell banks to support biologics production.
Development and optimization of upstream and downstream processes, including scale-up to clinical and commercial volumes.
Design, development and qualification of analytical methods supporting characterization, release and stability testing.
Optimization of drug product formulations and associated stability testing to support clinical and commercial product profiles.
Full-service viral removal and inactivation study programs with regulatory-compliant reporting, available standalone or as part of integrated CDMO projects.
cGMP production of biologic drug substances and aseptically filled drug products for clinical and commercial supply, across microbial and mammalian platforms.
Expertise Areas
- Cell line development and banking
- Upstream and downstream bioprocess development
- Biologics manufacturing (microbial and mammalian)
- Analytical method development and characterization
Key Technologies
- Single-use bioreactor systems
- Stainless-steel bioreactors
- Microbial fermentation
- Mammalian cell culture
News & Updates
Northway Biotech has entered into a manufacturing agreement with Kaida BioPharma for the production of KAD101, a targeted anti-cancer therapy. The collaboration includes process development, analytical methods, and GMP manufacturing for clinical studies.
Northway Biotech has expanded its service offerings to include Viral Clearance Studies with faster turnaround times, supporting gene therapy and biologics development.
The company was recognized for its contribution to Lithuania’s biotech sector and its role in developing the BIO CITY project.
Northway Biotech received industry recognition for its performance and reliability in biologics CDMO services.
Emerging biopharma companies need personalized support from development to manufacturing. Northway Biotech offers integrated services supporting biologics throughout the lifecycle.
Recognition for Northway Biotech's excellence in biologics development and manufacturing services.
Northway Biotech has entered into a manufacturing agreement with Kaida BioPharma for the production of KAD101, a targeted anti-cancer therapy. The collaboration includes process development, analytical methods, and GMP manufacturing for clinical studies.
Northway Biotech has expanded its service offerings to include Viral Clearance Studies with faster turnaround times, supporting gene therapy and biologics development.
The company was recognized for its contribution to Lithuania’s biotech sector and its role in developing the BIO CITY project.
Northway Biotech received industry recognition for its performance and reliability in biologics CDMO services.
Emerging biopharma companies need personalized support from development to manufacturing. Northway Biotech offers integrated services supporting biologics throughout the lifecycle.
Recognition for Northway Biotech's excellence in biologics development and manufacturing services.