Animal testing could be eliminated; Kirkstall

Speaking to Outsourcing-Pharma at CPhI 2009 Darley commented that no one system will be able to replace animal testing but suggested that using numerous different technologies may present a viable alternative.

This could be more ethical and economical than animal testing, according to Darley who also thinks it may provide a framework that can more accurately predict a drug’s effect on the human body.

However, Darley believes that a shift to this model may be hindered by regulations as much as technology. Regulatory agencies have become used to relying on data from animal studies and it will take time and a body of evidence to shift their stance.

Darley believes that Kirkstall has begun accumulating this evidence for its advanced cell culture biomodule, which was nominated for the innovation award at CPhI 2009 in Madrid, Spain.

Ian Siragher, commercial director at Agenda1, a company providing the solubilising system for the biomodules, explained to Outsourcing-Pharma how the technology works.

The biomodules consist of 3D scaffolding for cell culture. Through this flows nutrient media, in which a drug can be solubilised, to provide a platform for testing the impact of a therapeutic on certain cells.

By linking multiple of these biomodules a “quasi vivo​” system can be created. For instance, linking biomodules containing skin and liver cells allows the user to witness communication between the different tissue types and more accurately predict irritation.

Furthermore, users can grow different cell types from an organ in the same biomodule, for example those in different layers of the skin, to investigate the impact of cell-to-cell communication on the drug’s effects.

Building a system​

Kirkstall has linked 32 biomodules in an attempt to mimic human metabolism and the system is being used by academics that help to validate the system, providing information on topics such as optimal flow rates.

Darley explained that “validation is incredibly important​” when convincing pharma companies of the systems effectiveness, adding that the economic and ethical benefits are attractive to these businesses.

By using the biomodules before toxicology studies the user can evaluate several candidates in a cost-effective manner, according to Darley and Siragher. It can take three to six months to set up animal testing and the biomodules could help companies have a better understanding of their products before beginning this step.

The system has been commercially available since April and can be used on a contract basis or purchased for use in-house.