Alder Therapeutics will help CDMO NorthX expand its services into pluripotent stem cells and help to design and validate process development and GMP-manufacturing labs in Sweden.

Investor group Flerie launched contract development and manufacturing organization (CDMO) NorthX Biologics in 2021, through the acquisition of a former-Cognate plant in Matfors, Sweden from Charles River Laboratories.

The entity has focused on providing plasmid DNA and technical protein production at commercial scale but is now expanding into cell therapy services, establishing GMP-manufacturing labs at the Matfors facility and at its Karolinska University Hospital campus in Stockholm.

Image: Stock Photo Secrets

The expansion will be supported by Alder Therapeutics – a venture recently set-up by Kristian Tryggvason – which, in addition to its own product development, will help NorthX design and validate its facilities.

“NorthX has one of Northern Europe’s largest clinical-grade manufacturing capacities for plasmid DNA, recombinant proteins, cell banking and associated gene therapy services and this expansion into cell therapy is a major step to complete our offering for innovative clients,” said Ted Fjällman, CEO of NorthX. “We are especially excited to work with Dr. Kristian Tryggvason, a leader in cell therapy technologies, and his team.”

A spokesperson from NorthX told us the firm is moving into this field due to both the needs of patients and due to the robustness of the advanced therapies market.

“From a patient impact perspective cell therapies have the possibility to treat or cure indications that have no hope of treatment today.  Examples of these are people that are paralyzed with spinal cord injury, severe diabetes that is extremely difficult to control with insulin, Parkinson’s, several different eye diseases making people fully/partial blind and people with decreased heart function after heart infarctions,” we were told.

“From the business side of things, we see a huge amount of investment going into the cell and gene therapy space and we want to be the leading supplier in this space.  There are no other service providers that dedicate themselves to serving this industry in its entirety and that is what we aim to achieve.”

The spokesperson would not reveal the extent of the investment by the company, but told us NorthX is “hiring competence for both allogeneic and autologous cell therapy development and manufacturing including all the necessary equipment needed for these operations.”