Frequently asked questions
At what stage can you take on a biologics program?
We can take on programs from early development through clinical manufacturing, as well as later-stage programs with an established cell line and process. If development work has already been completed elsewhere, we assess what is available and define what is needed to transfer, scale, and prepare the process for manufacturing at Northway Biotech.
Can you work with a cell line or process developed by another CDMO?
Yes. We can onboard client-owned cell lines and processes developed internally or by another CDMO. We review the available development history, process data, analytical methods, and manufacturing information to identify any gaps and establish a transfer plan appropriate to the maturity of the program.
How do you manage technology transfer into your manufacturing facilities?
Technology transfer is managed by a cross-functional team spanning process development, analytical, manufacturing, quality, and other relevant functions. We assess the incoming process, identify technical and operational risks, and define the studies or adaptations needed for transfer and scale-up. The extent of the work depends on the maturity of the process and the requirements of the program.
Can you support both mammalian and microbial biologics?
Yes. Our biologics capabilities cover both mammalian and microbial expression systems. For mammalian programs, we support CHO-based production with single-use manufacturing up to 4,000 L working volume. For microbial programs, we work with bacterial and yeast expression systems, with fermentation capacity up to 4,500 L working volume.
Can you optimize an existing process before cGMP manufacturing?
Yes. An incoming process does not need to be manufacturing-ready. Where needed, we can address process performance, robustness, scalability, or manufacturability before transfer into cGMP manufacturing. The scope is based on the existing process knowledge, program stage, and the specific risks identified during assessment.
Can you evaluate a different expression system if the current one does not meet our needs?
Yes. Where there is a clear technical rationale, we can evaluate alternative expression strategies. The decision is considered in the context of product quality, productivity, scalability, development timelines, and the additional development or comparability work that a change may require.
Do you have in-house capabilities for viral clearance studies?
Yes. We have six BSL-2 laboratories in Vilnius supporting viral clearance studies, alongside specialized infrastructure for viral and advanced therapy development.
Where are your biologics development and manufacturing capabilities located?
Our biologics operations span Vilnius, Lithuania, and Waltham, MA. Programs can draw on capabilities across our European and US sites depending on the development, manufacturing, and supply needs of the project.
WHAT EXPERIENCE DO YOU HAVE WITH INSECT CELL EXPRESSION?
Our team brings experience with , supporting the development and manufacture of recombinant proteins and other complex molecules. This experience enables us to support clients as their programs progress through clinical development and toward commercialization.
