Release By Exception Saves Time And Money In QC Activities

Release by exception is an aspiration that could significantly reduce therapeutic release time and cost. Currently, quality compliance (QC) cost of autologous products can comprise up to 32% of COGS per dose, while making up to 23% of COGS per dose for allogeneic products. In both autologous and allogeneic cases, QC cost is the second highest cost factor, second to only the cost of consumables.i

For small lot sizes of 50 doses per lot, QC costs can run even higher, at more than 50%. These high costs are due in large part to the significant manpower needed to review hundreds of pages of batch information before the batch can be released.

Adopting manufacturing automation technologies would allow quality teams to implement a release by exception process which would drastically reduce the number of costly reviews required, saving on both the time and money needed to produce cell therapies. Release by exception is a review approach where quality teams would review information only when pre-established targets are not met, or certain alarms are triggered. This means that products can be released automatically unless pre-defined metrics are not met.