Frequently asked questions
What types of products can you manufacture?
Our cGMP manufacturing capabilities span biologics, gene therapy, and cell therapy, including mammalian- and microbial-derived biologics, viral vectors, plasmid DNA, and advanced cell therapy programs.
Can you take on a process developed elsewhere?
Yes. We can onboard established processes developed by clients or other CDMOs. Our teams assess the available process, analytical, manufacturing, and quality information and establish a technology transfer strategy appropriate to the maturity and requirements of the program.
What manufacturing scales can you support?
Our network includes mammalian manufacturing up to 4,000 L working volume, microbial fermentation up to 3,000 L working volume, viral vector production up to 1,000 L working volume, dedicated pDNA production up to 300 L working volume, and BSL-3 production capability up to 200 L working volume.
Can development and manufacturing be integrated?
Yes. Programs can progress from cell line or process development through analytical development, scale-up, technology transfer, GMP manufacturing, and drug product activities within Northway Biotech.
Do you support both drug substance and drug product manufacturing?
Yes. Our capabilities extend from GMP drug substance manufacturing through formulation and aseptic fill & finish. Three fill & finish lines across Vilnius and Waltham support multiple drug product formats.
Where are your cGMP manufacturing capabilities located?
Our manufacturing network spans Vilnius, Lithuania, and Waltham, Massachusetts, with dedicated infrastructure supporting biologics, gene therapy, cell therapy, and drug product manufacturing.
