Biotherapeutics are widely used across the whole pharma sector. Examples include vaccines, therapeutic antibodies, genes (for gene therapy), and cells (for cell therapy).
When testing these biotherapeutics in patients, the timing of sample extraction can give a variety of information, such as the pharmacokinetics (PK) of the therapy. PK looks at how the body affects a drug as it passes through i.e., absorption, distribution, metabolism, and excretion. For example, the effective dose of a biotherapeutic may be present in the blood for up to one year, which can affect minimal effective dosing. These tests also highlight safety concerns early on, avoiding obstacles and delays.
When monitoring biotherapeutics, the drug’s effective concentration in blood is measured at timed intervals, giving an acute picture of the effects at a certain point in time. Therefore, biotherapeutic assays, from PK to anti-drug antibody (ADA), must be fit-for-purpose, accurate, and high-quality to ensure patient safety and solid results.
Sanquin PBS is a globally recognized key opinion leader that combines science and clinical practice to create and implement ready-to-go assays with direct results. As a co-creator of the field of biomonitoring of biotherapeutics, Sanquin PBS has provided decades of consistent performance, adhering to GCLP requirements, publishing over 200 peer-reviewed publications in the field, and contributing to numerous clinical guidelines. The in-house biotherapeutic assays (such as PK/PD (pharmacodynamics) and ADA assays) developed have a long scientific and clinical track record which allows for meaningful interpretation of results.