Hoeford is able to assist developers and manufacturers of recombinant vaccines and biotherapeutics with in vivo antibody raising using ELISA (Enzyme-Linked Immunoabsorbent Assay).

Monoclonal antibodies (mAb) are increasingly important in the treatment of a broad range of viral infections and other conditions.

With so many patients and treatment-related variables impacting the ability of a molecule or substance to provoke an immune response, assessment of efficacy is an important element of regulatory approval.

The method involves immunising mice with vaccine/substance, taking blood at intervals, and measuring immunoglobulin G levels with ELISA.  Home Office licensing for this testing is subject to proof of unavailability of non-animal alternatives.

Testing the levels of antibodies produced following administration of a vaccine/substance is indicative of the success of the test product.

How is it done?

• Mice are immunised with antigen to generate an immune response
• Blood is collected from the animals after immunisation and the serum separated
• In the ELISA assays serum samples are added to antigen-coated plates for detection of bound antibodies
• An enzyme-conjugated secondary antibody is added to the plate to determine if the animal has produced antibodies against the antigen
• A substrate that reacts with the enzyme is added to the plate to determine binding of the secondary antibody to the primary antibody. Successful binding produces a coloured product
• The colour development is measured using a spectrophotometer to determine the concentration of antibodies in the serum, or antibody titre
• ELISA assay determines which animals have generated an immune response and selection for further antibody purification and vaccine/substance production