Protein drugs, one class of biologics, represent an increasing share of the pharmaceutical market and include both therapeutics and vaccines. The concentrations of protein analytes are typically determined using immunoassay methods. In one common format, a pair of antibodies are used to first capture a protein of interest onto a surface and then detect its presence. Detection can involve generation of colour by an enzyme, as in enzyme-linked immunosorbent assays (ELISA). Newer technology allows for detection by electrically stimulated emission of light in electrochemiluminescence (ECL) assays. TetraQ offers both ELISA and ECL assays, the latter via a state of the art Meso Scale Discovery (MSD) reader.
Like small molecule drugs, protein drugs are the object of pharmacokinetic (PK) measurements. However, as therapy with this class of drugs can lead to unwanted immunogenicity in the form of anti-drug antibody (ADA) responses, it is generally necessary to develop and validate both PK and ADA methods to support clinical trials for a protein active. Sponsors generally need to supply custom antibodies for this process, although in some cases commercial antibodies may be available. Development and validation of suitable PK and ADA methods can be a lengthy process and we encourage sponsors to engage early.
Beyond determination of actives, immunoassay techniques can alsobe used to assay protein biomarkers. Pharmacodynamic (PD) protein biomarkers are increasingly used to follow the course of inflammatory, metabolic and oncological disease. Commercial ELISA kits are available for many individual markers and can be used for sample analysis at TetraQ. We can also run multiplex MSD kits for standard or custom panels relevant particular disease states. Kits can be specified for human, rodent or non-human primate targets, and can include up to 100 biomarkers in a single kit.
TetraQ can also offer assessment of immune responses to vaccines and played a key role in The University of Queensland’s COVID-19 vaccine development work, both at the pre-clinical and clinical stages.