Through its Process Analytical Technologies (PAT) and Quality by Design (QbD) initiatives, the Food and Drug Administration (FDA) has created a regulatory framework that encourages the use of innovative technology to deepen manufacturing process understanding. During process development and in commercial manufacturing processes, Discoverant can help companies reduce process variability, improve yields and reduce batch failures.
Bristol-Myers Squibb noted that Discoverant fits well into the company's strategy for implementing PAT and QbD. In addition, enhancing data analysis capabilities during manufacturing process development for a new drug will help Bristol-Myers Squibb meet regulatory expectations that are critical to the approval and launch of new products.
Aegis' technology platform and application set provide a collaborative root cause analysis and decision-making environment to improve operational efficiencies and accelerate time to value by understanding the sources of variability and achieving overall process predictability. Discoverant provides users with interactive access to all types of process development and manufacturing data that is integrated with powerful analysis, trending and reporting capabilities.
"Companies like Bristol-Myers Squibb who are leaders in leveraging PAT and QbD can use Discoverant to gain process understanding and reduce product variability -- resulting in both regulatory and business benefits," said Robert Di Scipio, Aegis president and CEO.
About Aegis Analytical Corporation:
Aegis Analytical Corporation provides the only fully integrated manufacturing process management software system that enables life sciences companies to accelerate products to the market, improve operating efficiencies and satisfy regulatory obligations. Aegis' Discoverant software solution presents a complete view of the manufacturing process from raw materials to finished product to provide on-demand data access integrated with user-centric investigational analytics and reporting capabilities for all data types. To learn more about Discoverant, visit: http://www.aegiscorp.com.
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