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MES Implementation Maintains Chain of Identity

September 27, 2023

Avoid Errors, Reduce Risk, Increase Performance, & Stay Compliant

Control Associates will work with you to understand your manufacturing business goals, identify opportunities, develop a business case, and take a phased approach to implementation that is focused on ROI.
<span style="color:#00488e;">Customer Story:</br>MES Implementation Maintains Chain of Identity </span>
Customer Story:
MES Implementation Maintains Chain of Identity
With Cell/Gene Therapy, the treatment must be provided ‘vein to vein’ in a limited period of time—with the same rigorous controls as any other biologic. This manufacturer, not unlike others in this industry, also had additional process challenges to accommodate cell count variations in the starting material. In addition, this customer's autologous process requires maintaining strict chain of identity across the supply chain with no room for error.
<span style="color:#00488e;">The Big Benefit:</span>
The Big Benefit:
In Cell/Gene Therapy, the uniqueness of each batch requires it to be adjusted for every patient’s starting material. That’s where MES comes in: MES maintains control over a complex manual process; MES automatically tracks materials usage to an individual patient lot and maintains identity of the lot; and MES recipes help accommodate varied growth timelines for varying starting material.