Discover NorthX Biologics’ complete cell therapy production solutions
Every cell therapy product is special and NorthX Biologics is proud to adopt a flexible manufacturing operation where we together with the client tailor a manufacturing and testing process meeting the specific product’s exact requirements.
Flexible cell therapy manufacturing at the highest quality
NorthX Biologics offers a state-of-the-art manufacturing operation for cell therapy products. We operate modern EU grade B cleanrooms with open handling in grade A. This combined with our advanced ball room EU grade C area for closed processing using various types of production systems enables the support of most cell therapy types.
We’re here to support your mission of bringing life-changing therapies to patients in need. We specialize in the development and GMP manufacturing of various therapies.
With extensive in-house analytics including FACS based methods and sterility testing, we can provide full control and optimized timelines through the development phases.
At NorthX Biologics, our commitment to safety and quality is unwavering. When you select us for your cell therapy production, rest assured that your therapeutic products receive the highest level of care, precision, and efficiency.
Cell therapy capabilities
Once the correct cell type have been isolated, we expand the cells utilizing various technologies ranging from T-flask culture to automated bioreactors. We can handle both adherent cells like MSCs and suspension cells like dendritic and NK cells. We make sure to design processes suitable for the specific cell therapy product.
We design solutions to enable closed processing including cell wash, exchange of media. By addition of signal substances such as growth factors and cytokines differentiation and activation is induced. In the case of CAR-T products the cells are transduced using the viral vectors that can be sourced from external partners of manufactured in house.
The cells are harvested using gentle methods ensuring the sustained viability and functionality of the cells. The cells are concentrated to the defined cell density and formulated in a buffer suitable for administration to the patient.
Depending on the batch size, specific requirements for the cells, we offer both semi-automated and fully automated filling into the final container closure system. The semi-automated option offers the highest grade of flexibility and is done by experienced and qualified scientists in EU grade A with grade B background. The fully automated filling operation gives the highest possible aseptic assurance utilizing our robotic isolator filling service.
By applying controlled rate freezing the product is frozen ensuring a highly viable and active cell therapy product. The product is stored in ultra low temperature liquid nitrogen vapor phase freezers with 24/7 surveillance and alarm functionality ensuring the safest possible storage of the valuable product until the controlled shipping to the clinic.
Cell therapy is the future, let's journey together
Cell therapies can be complex but we are ready to support your project from start to finish. Let us know how we can help with your upcoming cell therapy project.