Benefit from our IVD Expertise
SERION Immunologics offers a range of customized services including antigen development and production, manufacturing of coated ELISA plates as well as buffer preparation and lyophilization. In addition, together with our partner ArkAb (Limoges, France), SERION Immunologics now offers custom development and manufacturing of monoclonal antibodies, especially for IgM. If you have any project in mind, please contact us to discuss feasibility and the best possible production procedure.
Antigens and antibodies:
Due to the long-term experience of Virion\Serion as a developer and manufacturer of high performing and recognized IVD infectious disease antigens, SERION Immunologics is capable to developing and manufacturing a wide range of antigens. Based on the additional expertise of our cooperation partner ArkAb (Limoges, France), we are also the right partner for the development of new monoclonal antibodies.
Because flexibility matters, SERION Immunologics offers all steps of customization, starting with the production of custom antigens according to already established production procedures and ending with the complete development of novel antigens and antibodies upon customer request. This includes all necessary development and production steps according to DIN EN ISO 13485 guidelines. The antigen production facilities are biosafety level 3 (BSL) certified and are additionally licensed for work with genetically modified organisms up to safety level 2 (S2). The laboratory license covers all organisms being classified as BSL3 and the facility is licensed for the work with animal pathogens and animal derived components. Together with modern laboratory equipment and an experienced team, SERION Immunologics is the ideal partner for all types of custom antigen and antibody projects, including viral, bacterial, fungal and parasitic antigens as well as state-of-the-art recombinant proteins from E. coli, yeast, Baculovirus and S2 insect cells.
ELISA Plate Coating:
SERION Immunologics offers a fully automated production line for ELISA coating, incubation and vacuum packaging. A modular system enables processing of up to four different lots with individual requirements in one production flow. Embedded in a DIN EN ISO 13485 certified production environment the state-of-the-art coating system is ready for your batch production.
SERION customized also comprises the production of tailor-made reagents or buffer formulations, beginning from a simple bottling up to the production of complex buffer solutions. Based on Institut Virion\Serion GmbH’s certification for the production of in vitro diagnostics according to DIN EN ISO 13485, all products are manufactured to the highest standards.
Freeze drying often increases the shelf-life of sensitive biological substances, such as antigens or antibodies, significantly. Therefore, this method is widely used in the manufacture of diagnostic reagents and components, such as CFT reagents or conjugates. Lyophilized products can be easily reconstituted with water or a suitable buffer and the reagent can be instantly used in a diagnostic test. Therefore, lyophilization is often the method of choice if a sensitive biological substance needs to be preserved for long-term storage or to remove the need for shipping of cooled or frozen reagents. Currently batch sizes of up to several thousand vials per lyophilization run can be freeze-dried under continuous quality conditions according to DIN EN ISO 13485.
Features and benefits - SERION customized
- Maximum flexibility
- Proven track record
- Technical customer support
- DIN EN ISO 13485 quality management system