Product lifecycle management is a critical enabler to allow the full realization of the commercial potential and long term value of a product. It is typical to associate product lifecycle management with major changes such as new formulations, new delivery devices, next generation processes etc., however, an important facet of this process is the enhancement of value derived from the improvements that are possible from continued process verification (CPV). Commercial bioprocess manufacturing facilities generate considerable amounts of process data which are routinely used for process monitoring. These process data also provide significant opportunities to further understand the interaction between operating parameters, process equipment and raw materials to enable improved process control and optimization. This talk will present case studies whereby significant process improvements were implemented for a complex protein biologic through the introduction of new process analytical technology and through the application of knowledge derived from CPV. These improvements led to significant increases in overall process robustness and increased overall yield by &gt;25% with minimal regulatory impact.<br/>

Maximizing the value of commercial scale data: A case study

251st National Meeting (2016)

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