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Humanised Antibodies

Why choose BBI’s Humanised Antibodies 

BBI Solutions’ humanised antibodies are reproducible and highly characterised preparations with defined purity at concentrations suitable for use as a critical raw material in rare autoimmune diseases. 

Uses of Humanised Antibodies in Immunoassays 

Immunoassays for the detection of antibodies in patient samples and serological methods require reference materials to determine cut-off values and test assay integrity, and these are then included in the kit as calibrators and positive controls. One of the latest advances in assay development is the use of chimeric antibodies as an alternative to characterised disease state plasma which is limited in availability, shows variability and also has safety and ethical issues. BBI has developed a range of specific chimeric antibodies for these applications where disease state plasma is difficult to source. 

Please contact our Customer Services Team directly to discuss your requirements on tel:+44 (0) 1495 363000 or alternatively you can submit an enquiry here.

How are humanised antibodies produced? 

Human chimeric monoclonal antibodies are produced in transgenic mouse strains in which the sequence for mouse IgG1 fc region is substituted with the human sequence. After mouse immunisation and the use of hybridoma technology, antibodies are generated that retain a human constant region for recognition by the anti-human conjugate.  

Autoantibodies against intracellular antigens are commonly found in connective tissue disorders. One example is SLE which can involve joints, kidneys, skin, mucous membranes and blood vessel walls. The idiopathic inflammatory myopathies dermatomyositis (DM) and polymyositis (PM) are characterised by the presence of inflammatory infiltrates within the skeletal muscle.  

Autoantibodies to tRNA synthetases are closely linked with AM/PM detection and diagnosis. Autoantibodies against PL-7 and PL-12 have been found in up to 6% of myositis patients. Anti SRP autoantibodies are mainly associated with a syndrome of a necrotising myopathy and severe prognosis. Autoantibodies against MI-2 are considered specific serological markers of DM. Detected in about 20% of myositis sera they are proven markers for acute onset and good response to therapy. Autoantibodies against PCNA are detected in about 5-10% of SLE patients.  

Are you developing an In Vitro assay? 

BBI now offers these specificities for IVD manufacturers developing in vitro assays that require a consistent, reliable source of raw material positive calibrator and quality control materials. Materials are stored and shipped from our Freiburg facilities. From this facility our materials are prepared and supplied directly to clients in Europe and non-China Asian territories. For customers in America and China, our Freiburg products are distributed through our carefully selected and highly reputable partners.  


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BBI Solutions Brands


The acquisition of DIARECT in June 2020 and their world leading recombinant autoimmune antigen capability immediately enhances BBI’s portfolio and position as a ‘complete’ immunoassay reagent supplier. This further enhances BBI’s position as the world’s largest diagnostics components company with a market leading antigen portfolio.


Maine Biotechnology Services brings 27 years of knowledge, experience, process development, and project management to our customers to ensure the best possible antibodies for any application. As antibody development goals in the biotechnology and pharmaceutical industry have evolved the acquisition of MBS will help BBI further meet and exceed our customers needs.


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