In an earlier post, Managing the Chain of Identity in Cell Therapeutics Manufacturing, we highlighted how the manufacturing process of these cell therapies must be performed with absolute accuracy the first time since each batch is produced for a specific patient. It’s critical during the production process that any execution errors be identified and corrected before completion. Any errors in development, manufacturing, or documentation can mean a missed treatment window for patients as well as financial and regulatory consequences for cell therapeutics manufacturers.Emerson’s Bob Schiros described how manufacturing execution systems, such as Syncade MES, help to reduce errors and deviations by automating manual procedures, integrating with other systems, automating calculations, and reviewing in-process data during the running batch. By automating workflows and improved electronic manufacturing, critical errors can be avoided or caught early enough to correct.
A well-designed and integrated manufacturing execution system helps reduce process errors by verifying materials, samples, process manipulations, and equipment. Calculation errors, occasionally introduced when performed manually during the batch run, are eliminated by automating the calculations.
These manufacturing execution systems provide integration with the underlying control systems, enterprise resource planning (ERP) systems, laboratory information management systems and computerized maintenance management systems (CMMS). This integration helps to assure that data is shared accurately, deviation management is easier to perform, and deviations are easier to eliminate.
The manufacturing process begins with the production order for the specific cell therapy to be produced. The production order includes the therapeutic to be produced, when to make it, how much to make, the equipment that should be used, the procedures to make it and the quality specifications required. This production order drives the interworking between the systems to meet the requirements in the timeframe and produce the documentation required to verify that everything was performed as designed.
This integration also helps assure the quality of the finished therapeutic from fewer deviation investigations and exception reporting. Because quality is improved, and less errors are made, faster quality assurance review and approval can be expected. Moving the review-by-exception process directly into the batch production process enables the finding and fixing of errors more quickly to assure quality and timely manufacturing.
Given the precision required to produce each unique cell therapy for each patient, it’s critical to reduce execution errors as quickly as possible during the running batch. The combination of manufacturing execution system technology and consulting expertise to effective plan & execute helps to automate procedures and provide manufacturing staff with the right information at the right time to make the right decisions.