Aqix have developed a new, non-animal derived serum that increases the supply, quality and shelf-life of fresh human tissue samples. This will reduce the time taken for pharmaceutical companies and contract research organisations (CRO) to obtain human tissue trials, reduce costs and speed-up pre-clinical trial evaluation.
The need for human tissue for pre-clinical drug testing is growing, due, in part, to the increased species-specificity of new drugs, especially biopharmaceuticals such as antibody therapies. Changes in regulations involving increased testing and high profile drug failures have only exacerbated the need for a constant supply of fresh tissue.
Talking to DrugResearcher.com, Matthew Durdy, Aqix CEO, said: "The key to the technology is to maintain the function of the cell by maintaining the exterior of the cell - the fluid immediately surrounding the cell membrane is critical in doing this."
The Aqix serum mimics natural serum by possessing almost identical pH and osmolality values as well as containing compounds to keep the energy cycles intact.
Durdy continued: "to keep the mitochondria functioning correctly you need to keep the whole energy cycle going."
The energy cycle is maintained by inclusion of three key ingredients: cocarboxylase, vitamin B1, which is needed to process carbohydrates, fats and proteins; L-carnitine, which transports long chain fatty acids across inner mitochondrial membranes for processing into the biological energy source, ATP; and insulin, which facilitates glucose transport into cells and its conversion into energy.
Conventional solutions, such as the Krebs Henseleit, use ionic phosphate buffers, which are not naturally occurring in extracellular fluid. Ionic phosphate damages cell membranes resulting in early cell mortality as well as causing calcium precipitation, which reduces cell receptor responses.
The serum is so effective that many CROs are using this technology as a base for their specific assays as it allows them to keep human organs alive for hours outside the body. It also increases the reproducibility of pre-clinical trials, as the calf serum that it replaces is notoriously variable.
Aqix estimates the current market for the transport of human tissue and its containment during bioassay at $50m (€38m) a year.
The serum is currently being investigated by UK hospitals for use in the normothermic transportation of human organs, where whole organs can be preserved at body temperature in a clean environment. The market for human organ transplant solutions has been estimated to be about $100m per year.
The serum may also find applications in both the regenerative medicine markets and the replacement blood markets.