Biologics Made Right First Time – On-Demand Process Quality Data


Biologics manufacturers are challenged today with reducing variability and costs, as well as speeding time to market by collaborating across growing manufacturing networks with external and internal partners spread across the globe. As they strive to develop and improve process performance and quality to meet business, regulatory and patient needs, effective utilization of their process and quality data is critical to success. The Biologics Made Right First Time Industry Process Exerience enables understanding of critical bioprocess drivers, monitoring variability for preemptive action and leveraging opportunities to maximize sustainability and maximize profitability and shorten time to market.

Many pharmaceutical and biopharmaceutical organizations are shifting their activities away from small molecule toward biologics drug development. The biologics R&D workflow from discovery through development to manufacturing is similar to small molecule R&D at the highest level but demands unique processes required by the added complexity of biological systems.

To design and implement robust biologics processes, monitor their performance, and to troubleshoot and introduce improvements to them, businesses need to make scientifically-informed decisions. Bioprocess and quality professionals need self-service, on-demand access and aggregation of process and quality data from multiple sources (including paper records) in the right context for analysis, interpretation and action enabling them to collaborate across organizations and geographies to convert data into information and then into process knowledge that becomes available for access and dissemination across global manufacturing networks.

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