Aligned route to GMP manufacturing for advanced biologics
We develop scalable, GMP‑ready manufacturing processes using harmonized methods from early development to commercial production. Our team works across microbial and mammalian expression systems to ensure strong process performance and optimal protein expression.
Gene-optimized CHO
cell line development
to GMP production
Developing a biologic should not be slowed down by fragmented workflows or restrictive licensing. Through our collaboration with Demeetra, we offer an integrated and royalty free path from cell line development to full GMP manufacturing. Powered by the optimized CleanCut GS CHO platform and advanced gene editing technologies, the pathway delivers fast, stable and high performing cell lines with a seamless transition into GMP.
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
We operate 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
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
We 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 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 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.
