The company is moving its production of the GAD65 protein, the active substance in its diabetes vaccine Diamyd, from abroad to Umeå, Sweden.
The new unit is around 1,000 square meters in size and contains clean rooms, laboratories and offices. Today, the unit has six employees, including protein scientists and quality management.
”We are short term going to add more GMP expertise. As the manufacturing process is established and scaled up we will also add additional laboratory personnel to make sure we can run the process at full capacity while in parallel developing new processes and know how,” says Maja Johansson, PhD, associate professor of neuroendocrinology, Site Manager in Umeå.
A university city
Despite being in the middle of a pandemic, Johansson says that the company has been very successful in finding highly qualified individuals.
”Umeå is a university city with an emerging life science research and biotech ecosystem.”
Paving the way for precision medicine treatments of type 1 diabetes
With the setup of a completely new facility within a highly technical and regulated industry, Johansson and her colleagues are paving the way for the development for future precision medicine treatments of type 1 diabetes.
”So, we aim to attract the excellence; individuals who are both experts in specific fields such as cell culture work, protein purification and analysis, quality management or GMP certification to manufacture GAD65, the active ingredient in Diamyd. And of course we need the skills able to collaborate across disciplines and to apply knowledge in areas of expertise other than their own,” she describes.
An exciting phase of development
Having the production in Umeå gives Diamyd Medical predictability and control over a core asset in the company, and in addition, the formulation process of Diamyd resides next door at APL.
”Having a well controlled and scalable process is key to succeeding long term with the drug development and commercialization. By making sure this is integrated in the company, we gain control and are less dependent on external factors and therefore less vulnerable to disruptive events,” explains Johansson. ”Personally it feels fantastic to be involved in building a vaccine facility from the ground up.”
Diamyd Medical is in a very exciting phase of development right now, the company has provided strong clinical data verifying the potential of the treatment targeting an identified genetic HLA group of individuals with type 1 diabetes, and is planning for the clinical phase III trial.
Photo of Maja Johansson. Photographer: Andreas Nilsson