Umeå-based life science company Diamyd Medical continues to recruit specialists for its new manufacturing unit. “For a scientist it is a fun and challenging place to work, where you really feel your knowledge makes a big difference and means something”, says Maria Åhman, Quality Assurance Manager at Diamyd Medical.
The company announced it was moving the production of GAD65 protein, the active ingredient in its diabetes drug Diamyd, from the USA to Umeå in the spring of 2020. Diamyd is currently being developed as a precision drug for patients with type 1 diabetes, with the clinical effects of the immunotherapy currently being evaluated in a phase 3 study. Moving production of the GAD65 protein was a long-term strategic decision that gives the company direct control over the technology.
In 2021 Diamyd Medical bought the 2,000 square-metre property where they are establishing the production – a SEK 24.5 million investment that has created the ideal conditions for development and scaling up of production.
The onsite team responsible for setting up production of the GAD65 protein say it is an exciting challenge to build a completely new facility in a new location.
“If you are technically and biochemically minded it’s a lot of fun getting to work with a tech transfer of cultivation and purification processes”, says Maria Åhman, who has worked at Diamyd Medical as Quality Assurance Manager since January 2021.
Even in this short space of time she has seen a lot of progress. Diamyd Medical has specified a large number of requirements and demands for the equipment it has purchased, as well as redesigned the facility to suit its processes. There was also a substantial rebuild of the cleanroom facilities last summer, before equipment began arriving that needed to be installed and commissioned.
“There were a lot of deliveries from Cytiva and several were built in Umeå, which feels satisfying. We have continued to buy in additional equipment, including laboratory equipment, and have worked intensely installing and testing them. Now we are working, among other things, on setting up all our regulatory documents and routines for risk assessments and deviation management in our digital systems”.
Diamyd Medical’s operations in Umeå are conducted with a palpable sense of enthusiasm and new-build spirit. As the facility grows, the company continues to attract new staff to Umeå, and is currently recruiting for a biomedical analyst and a specialist in microbiology.
“Right now we are setting up routines for the cleanrooms, but we will also be conducting microbiological analyses and need biomedical analysts when we make large-scale technical batches in the future. There are many different tests and final control analyses that will need to be carried out and evaluated before we can finally assess the results of a completed manufacturing round”, says Maria, and continues:
“We will continue to grow. For example, we will be hiring a process engineer with a focus on validation and we also need competences for supporting systems, data management, logistics and lab data systems”.
Maria says she can wholeheartedly recommend Diamyd Medical as a place to work, both for those who have recently graduated as well as those who have been in employment for a while.
“It is an amazing challenge – partly to build the entire factory, and partly the technology transfer itself. We’re a close and unpretentious group working here and we have high ambitions, with staff who come from different backgrounds in both academia and the quality-regulated/GMP world. Several are specialists in their field and everyone’s knowledge is important”.
In her role as Quality Assurance Manager Maria is responsible for product quality and safety, and oversees the quality systems that support Diamyd Medical’s processes. The company complies with the strict requirements for pharmaceutical production set by the authorities, and ensures its production processes comply with GMP requirements in Europe, as well as those in other markets.
”The purpose of these requirements is to ensure processes guarantee each patient receives a drug that is suitable for its intended use, which provides the intended effect, is safe and is always made to the same high levels of quality”, explains Maria Åhman.
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