Pre-clinical Safety

Biopta

Preclinical Safety Services

Drug Discovery and Development Services

Through an extensive array of ex vivo human tissue assays, 3D models and stem cells, REPROCELL is able to provide invaluable human safety data for your compound early in the development cycle. REPROCELL is the only GLP laboratory undertaking tests using human fresh functional tissues.

The benefits of undertaking safety testing in human tissues are many. When carried out in conjunction with the ICH S7A core battery, our data can provide an unparalleled indication of clinical safety and even reduce the number of animals required for in vivo experimentation. More importantly though, our data can help reduce the number of late stage failures as ‘go’ or ‘no go’ decisions can be made with confidence based on human responses.

In addition to the positive effect on cost and time to clinic, human safety data adds significant value for investors and potential partners.

Routine safety assays conducted by REPROCELL include:

ConditionTissueTechnique
Blood pressure Human subcutaneous resistance arteries Vessel diameter – wire myography
Myocardial infarction or angina Human coronary artery Vessel diameter – wire myography
Diarrhoea or constipation Human colon
Human gall bladder
Fluid transport – Ussing chambers
Gut motility – Organ baths
Gall bladder contractility – Organ baths
Cardiac contractility Human ventricular trabeculae Electrical field stimulation – Organ baths

 

Human heart
Human heart
Force of contraction measured in organ baths
Force of contraction measured in organ baths
Graph (isoprenaline)

Comparisons between human and animal data are often vital, as safety in animals does not always mean safety in humans. REPROCELL can conduct comparative pharmacology studies across the main preclinical species, generating data on your compounds in humans and animals.

Why do safety pharmacologists request human fresh tissue studies?

  • Unexpected observations during clinical trials
  • Observations from in vivo animal models
  • Known species differences for the target/mechanism
  • Requests from regulators (available as GLP studies if required)

 

The graph below shows the differences in responsiveness of bronchi from various species to a range of bronchoconstrictors. No species accurately predicts human responses.