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EN ISO 13485:2016, issued June 17th, 2020
Imusyn (founded in 2001) is a biotechnology company which specialises in alloproteomics with the objective of advancing allogeneic cellular therapies and personalised medicine. The company’s primary focus is the development and manufacture of recombinant proteins from polymorphic genetic systems including major histocompatibility complex genes, blood group genes and many other immunology related or immunogenetically relevant genes. Using proprietary recombinant protein technology makes a high-yield, massive parallel manufacturing process possible. With these techniques, we can meet the demands of customers on the medical diagnostic and life sciences markets for modern research tools in next-generation drug and diagnostic assay developments.
On the basis of its extensive expertise in molecular biology as well as an understanding of the relevant regulatory requirements, imusyn competently supports its clients in designing innovative diagnostic tools - which provide the highest sensitivity and precision - with its development, engineering, testing and manufacturing services. Imusyn is DIN EN ISO 13485 certified and can thus provide a comprehensive service to customers in developing in vitro diagnostic medical devices under the European regulations and in accordance with Directive 98/79/EC.
Independent of the diagnostic platform applied, we offer our customers a complete spectrum of services from genetic engineering through clinical evaluation management to in-market supply. In other words, we cover every step from gene expression to CE marking, including full project management support. Our services are fully integrated and supervised by our Quality Management Department to ensure that each individual development step will contribute towards achieving the most efficient and compliant manufacturing process possible.
Imusyn currently comprises an interdisciplinary team of 20 scientists, technicians and project managers experienced in development, production, and quality management in the fields of life sciences. The company has more than 600 square meters of R&D and QC laboratories and a 400 square meter state-of-the-art recombinant protein facility.
To date Imusyn has produced more than 30 products to advance allogeneic cellular therapies, is currently producing a number of CE-marked diagnostic assays and has also been involved in numerous assay developments throughout Europe and the US.