Case Study – Xanthus Pharmaceuticals

Lyophilized Product Formulation and Cycle Development

Situation

An emerging pharmaceutical company, focused on small-molecule therapeutics for the treatment of cancer and autoimmune disorders, was concentrating efforts on compounds that had previously undergone certain important developmental phases yet had been abandoned for any number of clinical complications. One such drug candidate was a cytotoxic material whose solvent-based formulation would require lyophilization for product stability. The client had attempted lyophilizing a number of formulations using basic laboratory vacuum equipment with little success. The client needed to finalize the drug formulation and produce enough material to proceed with pre-clinical testing. Due to its cytotoxicity, most labs with lyophilization capability did not want to handle the material.

Approach

IMPACT has a strong core competency in lyophilization including both operations and equipment design. To address the client’s issue, IMPACT arranged for the use of a used commercial R&D lyophilizer at minimal cost. The system was also modified to handle solvents versus typical water-based formulation. A number of safety procedures were implemented to protect against the cytotoxic material.

Results

IMPACT tested a number of different potential solvents and excipients, each of which was lyophilized into a dry powder. The best formulation was chosen and a second run was performed to produce enough material for the client to proceed with pre-clinical trials and thereby accomplished this technical milestone.