We conclude our series on improving cell therapy manufacturing with a closer look at the review by exception process.
In the manufacturing process of cell therapeutics, product cycle times are extremely short and any exceptions occurring during the production process must be found and addressed quickly.Emerson’s Bob Schiros notes that manufacturing execution systems, such as the Syncade MES, must include this exception reporting capability to address each of the thousands of batches manufactured each year. Getting batches out of the door faster – while ensuring quality – is especially important in the area of cell therapy manufacturing. Any delay can be catastrophic.
The review by exception functionality in the Syncade MES provides integrated exception reports to expedite the quality review processes, helping to quickly identify, review, and resolve issues during the batch production process.
By consolidating and logically presenting this data to the operators, it enables them to identify and resolve deviations that can impact product quality.
These exceptions or deviations can be flagged and used to drive the quality review process and focus on remediation steps. Incorporating this process and workflow into the batch production process can significantly reduce overall review time, getting medicine out of the door and delivered to patients quickly.
The earlier these exceptions can be identified and resolved, the earlier batches can be released with the quality level required for the particular cell therapy treatment.