On April 12, 1955, Cutter Laboratories was one of several companies that the United States government licensed to produce Salk polio vaccine.
The Tragedy
In what became known as the Cutter Incident, some lots of the Cutter vaccine—despite passing required safety tests—contained live polio virus in what was supposed to be an inactivated-virus vaccine. Cutter withdrew its vaccine from the market on April 27 after vaccine-associated cases were reported.
This tragedy resulted in 51 children been paralysed and a further 10 deaths.
Possible Causes
Several possible reasons were pinpointed including:
- Inconsistent viral inactivation process
- Quick scale-up production without proper validation of the inactivation steps – i.e trying to meet market demands without adequate Quality Control in place.
- A scale-up of heat inactivation step which may not have been sufficient
Lessons Learned
So what GMP lessons can we learn from this?
One of the obvious solutions would have been the introduction of a robust process validation coupled with batch by batch QC Testing and batch release system.
Process Validation
If you are not familiar with Process validation, it is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
