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EN ISO 13485:2016, issued June 17th, 2020
The company’s facility offers extensive research and production capacities to perfectly meet its customer’s requirements. This includes more than 600 square meters of R&D, QC and molecular genetic laboratories and a 400 square meter state-of-the-art recombinant protein facility.
The Molecular Genetic Facility covers all technologies used in molecular diagnostics and genetic profiling including next generation sequencing technologies. The facility’s vector technology offers maximal flexibility for genetic engineering of all types of mammalian or bacterial cells.
The Recombinant Protein Production Facility brings together comprehensive technologies for high-quality, massively parallel and flexible scale production of recombinant proteins in eukaryotic and prokaryotic hosts. A full spectrum of protein purification development methods and fully automated protein purification instrumentation guarantees the ideal and reproducible level of protein purity for all downstream applications. The superior protein production and purification facility with large-scale production capacity can meet our customer’s needs in all aspects.
The Molecular Genetic and Recombinant Protein Production Facilities are supported by the expert capabilities of an interdisciplinary team of scientists in the fields of biochemistry, cell biology, immunoassay techniques and molecular biology.
These facilities maintain a stringent quality management system for all procedures and fulfil national and international regulations for in vitro diagnostics and medical devices. This includes DIN EN ISO 13485 certification and European regulations according to the Directive 98/79/EC.