REPROCELL can help you reduce the risks of clinical failure via our assays in human fresh tissues. Human tissue testing gives an accurate indication of human safety (including to GLP), efficacy, and bioavailability in advance of expensive clinical trials.
This invaluable information allows you to make ‘go’ or ‘no-go’ decisions with greater confidence, based on human data generated in tissues sourced from the target patient population.
Our expertise in all areas of human tissue testing – including ethics, sourcing, handling and fee-for-service experiments in human fresh tissue – allows us to act as your “Human Tissue Research Department”.
Human tissue testing is being increasingly recognised for its translatability. As a result, the regulators encourage the use of human tissue testing in safety assessment.
When the International Partnership for Microbicides (IPM) approached the EMA for approval of an intravaginal drug-eluting ring to reduce the incidence of HIV transmission, additional data was requested to investigate the potential effects on surrounding organs.
Our scientists designed and conducted a study in human fresh uterine tissue, measuring the effects of the drug on uterine contractility. No effect on uterine contractility was observed ex vivo, which contributed to the safety assessment process, and in 2020, the ring received regulatory approval in Europe.
Preclinical models remain over-reliant on animals and simple cell culture systems. Although many biological pathways are conserved across species, significant differences in drug response, drug metabolism and drug absorption exist between animals and humans.
Predictive preclinical assays in fresh, intact human tissues avoids species differences, providing a more accurate prediction of the likely responses of patients during clinical trials. Moreover, the advent of precision medicine is driving the need for human-relevant predictions of drug efficacy, to better understand drug effects in patient sub-populations much earlier in drug development.
Read our case study on Amgen's publication, which highlights the useful comparisons that can be made between matched tissues from preclinical species and humans. The species comparison studies allowed identification of the receptors involved in the adverse effects observed in the clinic and underpinned a risk mitigation strategy to counteract side-effects.
Adverse effects may go undetected during preclinical safety assessments and only become apparent during clinical trials. In most cases, such adverse effects in humans were not observed in animal models.
At Reprocell, we investigate adverse effects using human fresh tissues to better understand mechanisms of action and identify mitigation strategies.
Predictive Drug Discovery Assay Services