BBI’s recently-acquired and well-respected team based in Freiburg, Germany (DIARECT GmbH) has developed two new recombinant antigen preparations produced in Baculovirus transfected Sf9 cells.

The antigens Nucleocapsid (N) protein and Spike (S) glycoprotein Receptor Binding Domain (RBD) have been designed as critical raw materials for next generation serological assays.

With the continuing COVID-19 vaccination programme, testing for antibody response will become increasingly important. Antibody tests detecting immune response to both the conserved and abundant nucleocapsid and the receptor binding domain that is unique for the SARS-CoV-2, will deliver physicians important information for disease management.

Serology testing is strongly suggested to play a major role in screening populations to determine exposure, as well as potential immunity, to identify recovering individuals as plasma donors as well as for research on immune response and to help identify neutralising antibodies (Amanat et al. 2020; Farnsworth and Anderson 2020; Okba et al. 2020).

BBI Solutions has seven manufacturing sites across four continents and has an established reputation as a leading manufacturer of biological reagents and finished test platforms for the in-vitro diagnostics market. The lateral flow manufacturing centre of excellence in Wales, UK is also part of the UK-Rapid Test Consortium (UK-RTC).

BBI Solutions acquired the Germany-based specialist manufacturer of autoimmune, infectious disease and allergy antigens DIARECT last year. This launch is the latest of new products in the pipeline. BBI’s two novel antigens are produced and characterised in the company’s ISO 13485:2016 compliant laboratories in Freiburg, Germany.

Dr Mario Gualano, Chief Executive of BBI Group, said: “These recombinant antigens are a welcome addition to our product catalogue and complement our existing range. We were delighted that our expertise in Freiburg can add a further component to the support BBI can offer the IVD industry in the fight against this pandemic.”  

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