Biopta Ltd is a GLP CRO specialising in predictive functional tests in human tissues.
We use ethically obtained tissues to provide early adverse effect screening in man. Human in vitro pharmacology studies bridge the gap between animal in vivo data and the clinic and offer invaluable human data much earlier in the drug development process, helping to reduce the risk of late stage failures.
Biopta’s core expertise is utilising fresh isolated ex vivo human tissues and measuring a functional response such as an unwanted constriction or dilation. With a specific focus on Safety Pharmacology, we complement the ICHS7A Core Battery of studies by assessing the safety profiles of compounds in man.
Biopta’s human tissue assays, with full GLP compliance, provide invaluable preclinical supporting data in man. The ICHS7A guideline proposes a battery of safety studies which are required to be conducted to GLP prior to human exposure. These studies include; cardiovascular assessment, an assessment of central nervous system effects and respiratory function.
Routinely, these assessments are carried out in animal in vivo models; however at Biopta we are able to provide powerful supporting data in functional human tissues and cells, entirely to GLP.
Safety profiling in human tissue delivers accurate data on the safety of your compound in man, reducing the extent of in vivo animal testing required and eliminating species variation.
It is Biopta’s recommendation that fully GLP, human in vitro safety pharmacology testing is carried out as part of your preclinical development program, delivering powerful human safety data prior to expensive Phase I/IIa studies.