Accelerated stability studies to support a screening IND
An international pharmaceutical company had a large drug development group that was fully committed to existing programs. They did not have sufficient internal resources to devote to development of a new candidate.
The compound had been in research for three years and early GLP toxicology studies had been initiated. There were metabolic differences between the various species, so the client needed to evaluate the metabolic properties in healthy human volunteers within six months, to be followed three months later by Phase I clinical trials. To support the clinical program, the client needed to set up accelerated stability studies of a drug product and a matching placebo, and schedule GMP manufacturing of the product.
The client had sufficient quantities of non-GMP API and a qualified HPLC method that would need to be installed and qualified prior to compounding, filling and starting the accelerated stability studies. They had never made the product on the scale that they were requesting, and the compounding procedure was not optimized. The timelines of the program were exceedingly tight: method installation and qualification, compounding, filling and labeling needed to occur within two weeks in order to obtain sufficient accelerated stability data prior to dosing the healthy volunteers.
WLI responded to the clients' requests by starting the method installation and qualification immediately. Simultaneously, we wrote protocols for all of the processes, such as compounding, filling, labeling, finished product testing, data management, and reporting, and procured all of the necessary supplies and equipment. Upon completion of the analytical work, the product and placebo were manufactured, tested and placed on stability.
All of the timelines were met, and the client was particularly pleased with the rapidity with which we responded to their needs as well as with the quality of work. Additionally, there were some unforeseen issues that arose during the compounding process which we helped them to troubleshoot to ease the transition to the GMP manufacturing site. The stability results were acceptable and the manufacture of GMP drug product and the clinical dosing were started according to the original timeline.