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Our microphysiological systems (MPS) allow researchers to set up human 3D cell culture assays and generate results quickly.
Standard in vitro DMPK studies face many challenges including, incompatibility with new therapeutic modalities, inaccurate predictions of human in vivo clearance rates (particularly for low clearance compounds) and missing rare or human-specific metabolites.
Mera systems can be used to study human drug absorption, distribution, metabolism and excretion (ADME) to help inform parameters such as dosage regime and effective drug concentration. To date, these insights have been gained using single-organ tissue models, often built from multiple cell types, however, the new Mera offers a unique capability to improve the prediction of in vivo pharmacokinetics and pharmacodynamics by interconnecting two tissues related to ADME.
With safety concerns being the principal cause for phase 1 and 2 clinical trial failures, it is clear that more predictive models are required to improve the translatability of data from the laboratory to the clinic.
Safety toxicology testing traditionally occurs in simple cell culture systems which lack physiological complexity, and animal models that are limited by cross-species differences. Many drugs with clean toxicity profiles in these systems will present with adverse effects in human trials leading to costly late-stage withdrawals and potential harm to study participants.
Mera allows scientists to identify and address potential side effects early in the drug discovery pipeline, using advanced in vitro single-, or multi-organ models, whose phenotype and functions mimic those in vivo. It provides a deep mechanistic, human-specific, understanding of potential drug toxicity that complements data derived from in vivo models for more insightful next step decision making.
The reality is that, even when two patients are diagnosed with the same disease, the behaviors of their respective phenotypes remain quite diversified, making each individual’s disease one of its own kind. To this end, the MPS technology, featuring miniaturized units of functional tissues or organs, may bring us true precision medicine, by allowing screening of drugs or drug combinations in a personalized manner before the most effective options applied to one’s own self.
A small-scale microfluidic palte can be designed to integrate various biomimetic cues, including those of biophysical and biochemical in nature, in addition to the tissue/organ models hosted within, which may derive from the patient’ cells – or sometimes simply a piece of patient’s explanted tissue. When multiple chips each containing a different tissue/organ model are interconnected into a compartmentalized system, the multi-tissue-drug interactions may further be picked up, to better predict how the drug is exerting effects on the patient as an organism.