Frequently asked questions
At what stage can you take on a cell therapy program?
We can support cell therapy programs from early process development through technology transfer and cGMP manufacturing. Programs can also enter with an established process developed internally or elsewhere. We assess the available process, analytical, and manufacturing information and define the activities needed to transfer, optimize, scale, and prepare the process for manufacturing at Northway Biotech.
Which cell therapy modalities can you support?
Our cell therapy infrastructure is designed to support multiple cell-based modalities, including CAR-T, CAR-NK, TIL, MSC, and other. Capabilities include both adherent and suspension cell processing, allowing the manufacturing approach to be adapted to the characteristics and requirements of the product.
Can you work with a cell therapy process developed elsewhere?
Yes. We can onboard client-owned processes developed internally or by another development or manufacturing organization. We assess the available development history, process information, analytical methods, equipment requirements, and manufacturing strategy to define an appropriate technology transfer plan.
Can you optimize an existing cell therapy process before cGMP manufacturing?
Yes. An incoming process does not need to be manufacturing-ready. Where needed, process development and optimization activities can be incorporated before technology transfers into cGMP manufacturing, with the scope defined according to the maturity and requirements of the program.
Do you have capabilities for 3D bioprinting and tissue engineering?
Yes. Our cell therapy platform includes 3D bioprinting and tissue engineering technologies, extending our capabilities beyond conventional cell processing, and providing infrastructure for the development of more complex cell-based and tissue-engineered products.
How do you manage technology transfer into your cell therapy manufacturing facility?
Technology transfer is managed across process development, analytical, manufacturing, quality, and other relevant functions. We assess the incoming process, identify technical and operational requirements, and define the development, qualification, or adaptation activities needed to establish the process within our manufacturing environment.
Can cell therapy programs be integrated with viral vector and plasmid DNA services?
Yes. Cell therapy programs can draw on complementary viral vector and plasmid DNA development and manufacturing capabilities within Northway Biotech. This provides an opportunity to coordinate interconnected elements of an advanced therapy program within one CDMO.
Where are your cell therapy development and manufacturing capabilities located?
Our viral vector and gene therapy capabilities are based at our Vilnius, Lithuania cell therapy CDMO site.
