- FlexFactory platform enables Diamyd Medical to manufacture its key protein GAD65 for type 1 diabetes precision medicine vaccine
- Diamyd Medical’s biologics manufacturing is located in Umeå, Sweden
- FlexFactory is a configurable single-use bioprocess manufacturing platform
Diamyd Medical will install a new Cytiva FlexFactory platform in Umeå, Sweden. Once up and running, the clinical stage biopharmaceutical company will begin manufacturing its precision medicine vaccine. The first of its kind, the type 1 diabetes vaccine works to reprogram immune cells to prevent the destruction of pancreatic insulin producing beta cells.
Globally, more than 1.1 million children and adolescents live with the autoimmune disease, type 1 diabetes1. Diamyd Medical develops therapies that target the underlying causes of diabetes. During clinical development of the vaccine, the global pandemic threatened its progress.
Ulf Hannelius, President & CEO, Diamyd Medical says: “The importance of being in control of your own manufacturing process for biologics has never been so apparent as during the present pandemic. With FlexFactory, we will be able to produce the biologic GAD, the active product ingredient in our diabetes vaccine. We chose Cytiva’s solutions thanks to the flexibility. The platform we use today can be transformed tomorrow to meet future growth and demand.”
Olivier Loeillot, Vice President of BioProcess, Cytiva, says: “We developed our FlexFactory platform to be flexable and scalable so companies like Diamyd Medical can respond to changing demands. Whether it’s smaller targeted therapies or larger scale manufacturing, the goal is the same: getting life changing therapies into those most vulnarable - quicker and more efficiently.”
The vaccine, the antigen-specific immunotheraphy Diamyd® targets approxiamately fifty percent of individuals recently diagnosed with type 1 diabetes, sepcifically individuals who carry the DR3-DQ2 human leukocyte antigen haplotype.
In over 80 installations around the world, FlexFactory integrated manufacturing lines accelerate research, clinical trials and commercial production of advanced and novel therapeutics and vaccines.
To learn more about how Cytiva’s enterprise solutions work click here. https://www.cytivalifesciences.com/en/us/solutions/bioprocessing/products-and-solutions/enterprise-solutions
About Cytiva
Cytiva is a global life sciences leader with more than 7,000 associates across 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture and delivery of transformative medicines to patients.
About Diamyd Medical
Diamyd Medical develops therapies for type 1 diabetes. The diabetes vaccine Diamyd® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results have been shown in a genetically predefined patient group in a large-scale meta-analysis as well as in the Company’s European Phase IIb trial DIAGNODE-2, where the diabetes vaccine was administered directly into a lymph node in children and young adults with recently diagnosed type 1 diabetes. A new facility for vaccine manufacturing is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd®. Diamyd Medical also develops the GABA-based investigational drug Remygen® as a therapy for regeneration of endogenous insulin production and to improve hormonal response to hypoglycaemia. An investigator-initiated Remygen® trial in patients living with type 1 diabetes for more than five years is ongoing at Uppsala University Hospital. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB.
Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser; phone: +46 8-528 00 399, e-mail: info@fnca.se
Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com Reg. no.: 556242-3797 Website: https://www.diamyd.com
The information was submitted for publication, through the agency of the contact person set out above, at 15.15 CET on March 16 2021.