Icebreaker Case Study

The Client

A client that benefitted from our Icebreaker service was a European virtual company with no lab facilities of their own. They had a compound for IV administration but with little supporting CMC data and no profiling data. Their existing pre-clinical formulation contained DMSO.

The Problem

The client's compound was poorly soluble. They had a limited quantity (2.5 g) of non GMP API to complete the formulation for the clinic. Furthermore, the pre-clinical form was identical to the clinical form. Commercially, the company was under great pressure from tight deadlines set by investors to reach the clinic.

How Icebreaker Worked

Icebreaker was used to explore different delivery approaches. In parallel, we profiled the compound’s strengths and weaknesses to fortify the CMC package. We also identified production and sterilization techniques. We focused on techniques that were transferable within the given time constraints.

The Results

• Identified cause of the insolubility and identified pH trick enabling increase in solubility within acceptable physiological pH
• Characterized the solid state supplied. Identified pseudopolymorph
• Conditions affecting stability identified along with incompatibility
• Aseptic processing identified as most promising sterilization process
• Bridged studies with GMP batch prior to transfer
• Recommended 2 lead manufacturing sites (lead with one back up)
• Tech Transfer to manufacturing site within 8 weeks of receiving compound

Primarily, Icebreaker got the client's compound into man fast. As well as providing a focused solution, we also built up a robust package for a sound understanding of the development space around the formulation. The service identified potential risk factors on the solid state properties, enabling the client to devise a clear development strategy to mitigate risk.