DIARECT AG, a privately held company founded in November 1998, specializes in the production and worldwide distribution of key components for development of diagnostic end products.

These crucial components can be proteins, nucleoproteins and nucleic acids that are used as antigens in diagnostic test kits for autoimmune and infectious disease detection. Due to the lack of high-quality antigens from natural sources, we produce these proteins and other components using biotechnological methods. DIARECT’s products are sold in over 25 countries worldwide. DIARECT is also the European distributor for SurModics assay and protein stabilizers, BioFx colorimetric substrates and for chemiluminescence substrates from Lumigen. DIARECT's quality management system is certified according to DIN EN ISO 13485:2003 and ISO 9001:2008

DIARECT’s expertise includes recombinant production of proteins that require expression in a eukaryotic system for proper conformation and activity. The scientists at DIARECT have expert knowledge of the baculovirus/Sf9 expression system for the production of recombinant human auto-antigens; furthermore, E. coli and mammalian cell systems have been established for particular expression tasks (Dr. Thomas Simon and Dr. Heike Schwarz).

The baculovirus/insect cell system is available at fermentation scales of up to 100 L, which allows the production of up to hundreds of milligrams of protein. For expression in E. coli we have a capacity of up to 20-L high density culture for the production of gram amounts of protein. Our upstream processes are complemented by the establishment of cell-free expression using bacterial, insect cell and mammalian systems.

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Participants for DIARECT

Richard Kneusel, PhD (M)

Dr. Kneusel received his BSc from the University of Wisconsin and his PhD from the University of Freiburg. Dr. Kneusel has extensive experience in R&D as well as marketing and business development at the Fraunhofer Institute and QIAGEN. He joined DIARECT upon startup (5% ownership) as one of four (1999) to over 40 (2015) employees. He developed and employed production protocols for protein purification, analysis, and packaging, and had an integral role in implementing QM-systems (ISO9000, ISO13485) and as internal system auditor. Further tasks include providing technical support and troubleshooting for customers, developing marketing material for print and web site.Dr. Kneusel is also general manager of BadenBioTec, a technology spin-off of DIARECT AG, involved in research and development of protein microarrays and assays for use in applied research and diagnostics. His responsibilities include direct day-to-day activities, plan marketing and sales schemes, structure strategic proposals, manage personnel, negotiate contracts, procure distribution products, and close sales transactions.

Iris Asen, PhD (F)

Dr Asen is the head of the production and protein chemistry department at DIARECT. She plans the day-to-day production and also organizes the research and development of new products. Dr. Asen has a broad knowledge of protein purification of diagnostically relevant proteins.

Armin Neininger, PhD (M)

Dr Neiniger is responsible for quality control and assurance at DIARECT. His department conducts routine quality analysis of products and processes. Dr. Neiniger has extensive experience in biochemical analysis and assay development. He is also an expert in the implementation of quality management according to ISO9000 and ISO13485.