Frequently asked questions
FAQs At what stage can you take on a microbial biologics program?
We can take on microbial programs from early development through clinical manufacturing, as well as later-stage programs with an established strain and process. If development work has already been completed elsewhere, we assess the available process and analytical information and define what is needed to transfer, optimize, scale, and prepare the process for manufacturing at Northway Biotech.
Which microbial expression systems do you work with?
We work with both bacterial and yeast expression systems and can develop strains with stable expression. The expression strategy is selected according to the characteristics of the target product, required product quality, productivity, scalability, and the needs of the overall development program.
Can you work with a microbial strain or process developed elsewhere?
Yes. We can onboard client-owned microbial strains and processes developed internally or by another CDMO. We review the available development history, process data, analytical methods, and manufacturing information to identify gaps and establish a transfer plan appropriate to the maturity of the program.
Can you optimize an existing fermentation process before cGMP manufacturing?
Yes. An incoming process does not need to be manufacturing-ready. Where needed, our upstream development team can optimize parameters such as media and feeding strategy, process conditions, productivity, and scalability before transfer into cGMP manufacturing. Small-scale qualifications, process characterization, and scale-up activities can also be incorporated according to program needs.
Can you develop the downstream purification process as well as fermentation?
Yes. Our microbial capabilities extend beyond upstream fermentation. We develop and optimize downstream purification processes with the goal of achieving the required product quality, recovery, robustness, and scalability. Upstream and downstream development are aligned so that the overall process can be efficiently transferred into manufacturing.
How do you manage technology transfer into your microbial manufacturing facilities?
Technology transfer is managed across 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 scope depends on the maturity of the existing process and the requirements of the program.
What microbial manufacturing scales can you support?
Our microbial manufacturing capabilities support working volumes up to 300 L and 3,000 L working volume across our facilities.
Can you support both microbial and mammalian biologics?
Yes. Our biologics capabilities cover both microbial and mammalian expression systems, allowing programs to access development, analytical, and manufacturing expertise across both platforms within Northway Biotech. This flexibility can also support evaluation of the most appropriate expression approach during development.
Where are your microbial development and manufacturing capabilities located?
Our biologics operations span Vilnius, Lithuania, and Waltham, MA, with microbial development and manufacturing capabilities available across our European and US operations. Programs can draw on capabilities across sites depending on development, manufacturing, scale, and supply requirements.
