Survey Case Study

The Client

A company that used our Survey service recently was a European biopharmaceutical client with a fairly small development team. They had great biological and chemical expertise but limited experience of developing poorly soluble compounds. A lack of time was a real concern for them as they were under considerable pressure from their management to select a viable lead candidate.

The Problem

The client had multiple leads to choose from. Various routes of administration needed to be examined. All of their potential candidates showed promising in vitro activity but inconclusive in vivo activity when the compounds were dosed as a simple suspension. An additional problem was the relatively low availability of drug substance: 150 mg of each, including supply for testing.

How Survey Worked

Focused studies were conducted to get a handle on delivery approaches. These were performed early on and at great speed, enabling in vitro results to be translated into in vivo performance. Survey identified feasible delivery approaches (crystalline, solubilized or amorphous) taking into account the early stage of the compounds.

The Results

• Crystalline and solubilized techniques compared and ranked
• All compounds equivalent in terms of physico-chemical properties
• One compound showed superior delivery properties enabling x50 higher concentrations to be achieved than the other candidates
• Small amounts: less than 100 mg used (including supply for in vivo testing)

Survey provided the client with a flexible formulation that could be explored across different administration routes. It helped them understand both the limitations and the benefits of each compound. The client evaluated and used the Survey data in conjunction with their biological data to select their preferred lead candidate. In this case, the compound selected for best efficacy also had the best delivery properties.