Scenario Analysis

Context: A major biopharmaceutical manufacturer had been forced by the FDA to change components of their product QA/QC to reflect advances in characterisation technologies that had occurred since the product was originally licensed. This was unexpected and was prompted by safety concerns for a competitor product, attributed to a given QA/QC consumable.

Solution: IPAV worked closely with the biopharmaceutical manufacturer, the regulator and the consumable supplier to conduct a failure mode and effect (FMEA) analysis for all QA/QC components to safeguard against future mandatory bioprocess changes, and streamline the process where possible, without making a “substantial change” to the process, requiring full revalidation.

Outcome: In less than one month, the FMEA was completed and findings presented to the client and regulator, these included replacing a number of QA/QC consumables for new low cost, disposable and higher sensitivity products. Overall, product cost of goods (COGs) and the frequency of process contamination were reduced, and the updated QA/QC regime is now the regulatory ‘gold standard’ for the product class. The client was also able to file and license formal IP around the updated process to their competitors.