Development of unwanted immunogenicity is a particular issue affecting therapeutic proteins. The development of anti-drug antibodies (ADA) can cause allergic or anaphylactic reactions, reduction in efficacy, or induction of autoimmunity. The risk of antibody formation is related to many factors including the production process, formulation and number of doses administered during the course of treatment.

Following current guidelines, we use a stepwise approach to assess the extent and nature of an anti-drug antibody response initiated by a therapeutic protein. The steps are as follows:

• Screening assay
• Confirmatory assay
• Neutralisation assay
• Characterisation assays (isotype, affinity etc)

BioAnaLab has the capability and expertise to provide a complete ADA service from screening through to characterisation.

We have experience using a variety of different methods to measure anti-drug antibody responses. These include ELISA/EIA/RIA, surface plasmon resonance (BIAcore), electrochemiluminescence (ECL), immunoblotting and neutralizing antibody assays (including cell-based assays). For large scale studies we have the equipment to automate assay handling where appropriate.

The development and validation of immunogenicity assays is under constant discussion within the industry. BioAnaLab is involved in international workshops and has an R & D programme underway to keep ahead of the latest developments in this area.