Diamyd Medical’s new unit is around 1,000 square meters in size and contains clean rooms, laboratories and offices.
Staff at the facility are experts in cell culture and protein purification – in other words everything required to produce the protein. In order to administer Diamyd in clinical trials the protein needs to be mixed with a liquid, known as a formulation. This step takes place at the pharmaceutical manufacturer APL, which is located right next to Diamyd Medical’s premises in Umeå.
“It is vital to have skilled personnel who understand all the production steps, the documentation required and have a complete knowledge of the current regulations”, says Maja Johansson, who continues:
“We are still in an active phase of expanding our workforce with key competencies at our production facility”.
Maja Johansson has a PhD in biochemistry from Umeå University and is an associate professor of neuroendocrinology. She previously worked at the spin-off company Umecrine Cognition, an early-stage drug project based on research in Umeå that progressed to testing its drug on patients.
“It was a very educational experience and gave me the knowledge I need to run the production facility in Umeå. I know what staff and what functions we need to get started”, says Maja Johansson.
Diamyd Medical’s test drug is the diabetes vaccine Diamyd, a precision medicine that specifically targets the disease.
“An example of how a precision medicine works is when, thanks to a large amount of collected data, you know so much about the patients and how the treatment works that you can choose which patients will benefit most from the treatment based on, for example, their gene sets.”, says Maja Johansson.
Previous clinical trials have clearly shown that individuals with the autoimmune form of the disease, type 1 diabetes, who carry a common genetic variant, seem to respond well to the treatment. Accordingly, recently announced results from a clinical trial show that this genetically predefined group of patients treated with the diabetes vaccine Diamyd, recorded more than 50 per cent higher retention of their own insulin production 15 months after the start of the trial compared to placebo-treated patients.
“We are now entering phase 3 of the drug development, which feels very exciting. It’s also extremely rewarding to bring the protein production to Sweden and handle it ourselves,” says Maja Johansson.
For more information about career opportunities please contact:
Maja Johansson, Site Manager at Diamyd Medical, Umeå
+46 72 571 92 20