As more protein-based therapeutics and biologics enter the drug development pipeline, the demand for technologies for immunogenicity testing is expected to become increasingly important. When taking a drug, a patient may initially or over time develop antibodies that block or interfere with the drug’s efficacy. The response can also result in life-threatening conditions.

In 2008, the European Medicines Agency (EMEA) and the FDA adopted new guidance on immunogenicity assessment of biologicals that provided general recommendations. To test for immunogenicity, drug developers develop assays to address unwanted humoral and cellular immunogenicity responses. In most cases, they focus their efforts on the detection and characterization of antibodies.

Consequently, biotechnology and pharmaceutical companies are investing in technologies to monitor immunogenicity of not only new drugs in the pipeline, but also of biosimilars and drugs already on the market. Although ELISA and microplate readers are typically employed to screen patient samples, other technologies, such as biosensors, are becoming more important to immunogenicity testing.

GE Healthcare offers the Biacore T100 and A100 systems, which are used to detect the immune response in serum samples. The Biacore systems, which are based on surface plasmon resonance technology (SPR), are used to screen for low-affinity antibodies. Low-affinity antibodies interact rapidly with drugs, and cannot be detected using traditional assays. The company recently introduced a software package specifically for immunogencity testing.

While SPR technology is the gold standard for biosensor technologies, it is limited in terms of throughput. Other instrument manufacturers have developed systems that have higher throughput capabilities. ForteBio’s OCTET instrument platform employs a standard 96-well format and utilizes bio-layer interferometry (BLI) technology. BLI is a label-free technology that analyzes the interference pattern of white light reflected from a layer of immobilized protein on the biosensor tip, and an internal reference layer. Any change in the number of molecules bound to the biosensor tip causes a shift in the interference pattern, which is measured in real time.

Meso Scale Discovery’s system utilizes electrochemiluminescence to detect binding events on patterned arrays for multiplex assays. The company offers solutions for cell-based assays, including NAb (neutralizing antibody) assays for quantitation of secreted proteins, such as cytokines, as well as for monitoring changes in receptor phosphorylation status, and characterizing interactions between proteins and cell-surface receptors.

While the biosensor market has been somewhat lackluster over the last few years, the market is experiencing renewed growth due to regulatory requirements for immunogenicity testing of biotherapeutics.

Immunogenicity Testing with Biosensors at a Glance:

Leading Suppliers

• GE Healthcare Biacore

• ForteBio

• Meso Scale Discovery

Largest Markets

• Biotechnology

• Pharmaceutical

• CROs

Instrument Cost

• $50,000–$350,000