Aligned route to GMP
We excel in the development of effective manufacturing processes compliant with regulatory expectations from pre–clinical to commercial needs. By adapting a structured development approach with aligned methods from early development to GMP manufacturing, we ensure the correct level of process control to rapidly progress your project to the next phase.
Microbial Protein Expression
NorthX Biologics is a trusted and leading provider of microbial development and manufacturing services. With our expertise and state-of-the-art facilities, we offer comprehensive solutions for the development and production of microbial proteins for various applications such as therapeutics, vaccines and technical use.
Results tailored to meet your specific needs
NorthX operates a flexible manufacturing option for GMP and non-GMP applications, ranging from fully closed single use systems to traditional cost–efficient large–scale stainless–steel plants enabling batch sizes from mg to kg scale. We have long experience from producing both intra cellular and periplasmatic proteins expressed in soluble form or as inclusion bodies.
Mammalian Protein Expression
At NorthX Biologics, we have extensive expertise in development and manufacturing of processes for proteins expressed in mammalian systems. We understand the intricacies of mammalian cell culture and the importance of optimizing upstream and downstream processes to ensure optimal yields and product quality.
Mammalian manufacture to the highest standard
NorthX Biologics offers a full range of mammalian services including adherent and suspension-based manufacturing systems.
Our fully compliant adherent manufacturing capabilities for cell lines such as HEK293 and Vero cells ensures an effective translation to GMP. The scales range from T-flasks to 500m2 fixed bed reactors ensuring full scale up possibilities in house.
For suspension cell lines such as CHO, HEK293 and PerC6 we offer a wide range of alternatives from shake flasks, Wave-mixing bioreactors to single use stirred tank bioreactors operated in batch, fed batch or perfusion mode.