A biopharmaceutical contract services organization was preparing for a Pre-Approval Inspection (PAI) and had two large compliance gaps to overcome. First, there was a substantial backlog of manufacturing deviations and lab investigations associated with their Process Performance Qualification (PPQ) and commercial launch inventory campaign. This required highly trained, experienced, and efficient resources to address in a condensed timeline, ahead of the Pre-Approval Inspection. Secondly, the client also required assistance and additional expertise related to addressing multiple validation gaps to demonstrate their cleaning methods were adequate and effective.


Backlog of manufacturing deviations, lab investigations, and re-execution of cleaning validation studies needed to pass pre-approval inspections


Kymanox® investigators provided support and expertise to increase efficiency in working through the backlog of deviations, lab investigations, and re-execution of studies


Kymanox provided support to execute the most complex technical deviations. This removed a large burden of work from the client and allowed them to focus on other aspects of preparation for the pre-approval inspections. The team was also able to provide microbial, analytical, and environmental expertise to support and resolve cleaning validation issues. This included resolving protocol deviations, establishing proper acceptance criteria, and suggesting more effective cleaning methods. Kymanox investigators provided support to improve throughput 3x-5x as compared to what the client could have achieved with their existing infrastructure alone. By adding to the client’s existing expertise, we were able to increase efficiency and get project goals across the finish line faster.